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PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00332202
Collaborator
(none)
758
Enrollment
153
Locations
2
Arms
85
Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
758 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
Other Names:
  • LY317615

    		•
    Placebo Comparator: B

    Drug: placebo
    oral, daily

    Outcome Measures

    Primary Outcome Measures

    1. Overall Disease-Free Survival [Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)]

      Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

    Secondary Outcome Measures

    1. Disease Free Survival at 2 Years [Baseline to 2 Years]

      Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

    2. Event-Free Survival [Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)]

      Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

    3. Event-Free Survival at 2 Years [Baseline to 2 Years]

      Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

    4. Overall Survival [Baseline to Date of Death from Any Cause (up to 80.30 months)]

      Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.

    5. Number of Participants With Treatment-Emergent Adverse Events [First dose through 30 days post-study treatment discontinuation (up to 81.30 months)]

      Number of participants with treatment-emergent adverse events.

    6. Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score [Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36]

      The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.

    7. Change From Baseline in EuroQol-5D (EQ-5D) Score [Baseline, Month 6; Baseline, Month 24; Baseline, Month 33]

      The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.

    8. Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells [Baseline to 24 months (2 years)]

      Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.

    9. Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression [Baseline to 94.5 months]

      Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).

    10. Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte [Month 2, Month 4: Predose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of diffuse large B cell lymphoma

    • Recently completed R-CHOP therapy and achieved remission

    • International Prognostic Index (IPI) score 3,4,5

    • At least 18 years of age

    • Agree to study follow-up schedule

    Exclusion Criteria:

    • Have received therapy other than R-CHOP for lymphoma

    • Serious medical condition such as infection,second cancer,heart disease

    • Received radiation to more than one lesion

    • Unable to swallow tablets

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anchorage Alaska United States 99508
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90095
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orlando Florida United States 32806
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chicago Illinois United States 60637
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bloomington Indiana United States 47402
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46202
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Iowa City Iowa United States 52242
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lexington Kentucky United States 40536
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Boston Massachusetts United States 02115
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Robbinsdale Minnesota United States 55422
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rochester Minnesota United States 55905
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia Missouri United States 65201
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Louis Missouri United States 63131
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durham North Carolina United States 27710
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tulsa Oklahoma United States 74136
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pittsburgh Pennsylvania United States 15232
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38138
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Houston Texas United States 77030
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. The Woodlands Texas United States 77380
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salt Lake City Utah United States 84103
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Everett Washington United States 98201
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seattle Washington United States 98104
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vancouver Washington United States 98686
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madison Wisconsin United States 53792
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Garran Australian Capital Territory Australia 2605
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gosford New South Wales Australia 2250
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Casuarina Northern Territory Australia 0811
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Woolloongabba Queensland Australia 4102
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg Victoria Australia 3084
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prahran Victoria Australia 3181
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nedlands Western Australia Australia 6009
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brugge Belgium 8000
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brussels Belgium 1000
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gent Belgium 9000
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leuven Belgium 3000
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Roeselare Belgium 8800
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belo Horizonte Brazil 30380-490
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Campinas Brazil 13083970
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Goiania Brazil 74075040
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rio De Janeiro Brazil 22260020
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. São Paulo Brazil 01223001
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edmonton Alberta Canada T6G 1Z2
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vancouver British Columbia Canada V5Z 4E6
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamilton Ontario Canada L8V 5C2
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toronto Ontario Canada M5G 2M9
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montreal Quebec Canada H3T 1E2
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Regina Saskatchewan Canada S4T 7T1
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beijing China 100083
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chengdu China 610041
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guang Zhou China 510080
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hangzhou China 310003
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nanjing China 210029
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shanghai China 200032
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Suzhou China 215006
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brno Czechia 62500
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Olomouc Czechia 775 20
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prague Czechia 128 08
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Herlev Denmark 2730
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Odense Denmark 5000
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Helsinki Finland 00290
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Avignon France 84902
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bayonne France 64109
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Roche Sur Yon France 85925
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Le Mans France 72000
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nantes France 44202
    66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nice France 06202
    67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nimes France 30029
    68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pessac France 33604
    69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rennes France 35033
    70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vandoeuvre Les Nancy France 54511
    71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berlin Germany 13353
    72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chemnitz Germany 09113
    73 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Erlangen Germany 91054
    74 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frankfurt Germany D-65929
    75 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Giessen Germany 35392
    76 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamburg Germany 20099
    77 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Homburg Germany 66421
    78 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kassel Germany 34125
    79 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mainz Germany 55131
    80 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Muenchen Germany 81675
    81 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Athens Greece 11527
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    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00332202
    Other Study ID Numbers:
    • 9823
    • H6Q-MC-JCBJ
    • PRELUDE
    First Posted:
    Jun 1, 2006
    Last Update Posted:
    Sep 10, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Period Title: Overall Study
    STARTED 504 254
    Received At Least One Dose of Study Drug 493 249
    COMPLETED 263 129
    NOT COMPLETED 241 125

    Baseline Characteristics

    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control Total
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1. Total of all reporting groups
    Overall Participants 504 254 758
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    62.19
    (13.13)
    62.65
    (12.09)
    62.35
    (12.78)
    Sex: Female, Male (Count of Participants)
    Female
    245
    48.6%
    105
    41.3%
    350
    46.2%
    Male
    259
    51.4%
    149
    58.7%
    408
    53.8%
    Race/Ethnicity, Customized (Count of Participants)
    African
    5
    1%
    2
    0.8%
    7
    0.9%
    Caucasian
    309
    61.3%
    155
    61%
    464
    61.2%
    East Asian
    144
    28.6%
    73
    28.7%
    217
    28.6%
    Hispanic
    24
    4.8%
    13
    5.1%
    37
    4.9%
    Native American
    1
    0.2%
    0
    0%
    1
    0.1%
    West Asian (Indian sub-continent)
    21
    4.2%
    11
    4.3%
    32
    4.2%
    Region of Enrollment (Count of Participants)
    Australia
    20
    4%
    9
    3.5%
    29
    3.8%
    Belgium
    10
    2%
    4
    1.6%
    14
    1.8%
    Brazil
    13
    2.6%
    5
    2%
    18
    2.4%
    Canada
    24
    4.8%
    16
    6.3%
    40
    5.3%
    China
    18
    3.6%
    7
    2.8%
    25
    3.3%
    Czechia
    6
    1.2%
    2
    0.8%
    8
    1.1%
    Germany
    15
    3%
    10
    3.9%
    25
    3.3%
    Denmark
    9
    1.8%
    4
    1.6%
    13
    1.7%
    Spain
    20
    4%
    5
    2%
    25
    3.3%
    Finland
    11
    2.2%
    5
    2%
    16
    2.1%
    France
    22
    4.4%
    10
    3.9%
    32
    4.2%
    Greece
    2
    0.4%
    2
    0.8%
    4
    0.5%
    Hungary
    4
    0.8%
    2
    0.8%
    6
    0.8%
    India
    22
    4.4%
    11
    4.3%
    33
    4.4%
    Italy
    15
    3%
    10
    3.9%
    25
    3.3%
    Japan
    54
    10.7%
    33
    13%
    87
    11.5%
    South Korea
    37
    7.3%
    21
    8.3%
    58
    7.7%
    Mexico
    13
    2.6%
    9
    3.5%
    22
    2.9%
    Poland
    9
    1.8%
    7
    2.8%
    16
    2.1%
    Puerto Rico
    3
    0.6%
    1
    0.4%
    4
    0.5%
    Portugal
    5
    1%
    3
    1.2%
    8
    1.1%
    Sweden
    19
    3.8%
    5
    2%
    24
    3.2%
    Taiwan
    24
    4.8%
    8
    3.1%
    32
    4.2%
    United Kingdom
    4
    0.8%
    4
    1.6%
    8
    1.1%
    United States
    125
    24.8%
    61
    24%
    186
    24.5%

    Outcome Measures

    1. Primary Outcome
    Title Overall Disease-Free Survival
    Description Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.
    Time Frame Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 504 254
    Median (95% Confidence Interval) [Month]
    42.8
    43.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.541
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.689 to 1.216
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Disease Free Survival at 2 Years
    Description Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.
    Time Frame Baseline to 2 Years

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 504 254
    Number (95% Confidence Interval) [proportion of participants]
    0.785
    0.2%
    0.748
    0.3%
    3. Secondary Outcome
    Title Event-Free Survival
    Description Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.
    Time Frame Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. EFS is censored at the last assessable disease-free assessment for participants who are alive, have not progressed or started new anticancer treatment. The number of censored participant data for enzastaurin and placebo is 364 (72.2%) and 176 (69.3%), respectively.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 504 254
    Minimum EFS Survival
    0.03
    0.03
    Maximum EFS Survival
    76.81
    71.56
    4. Secondary Outcome
    Title Event-Free Survival at 2 Years
    Description Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.
    Time Frame Baseline to 2 Years

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 504 254
    Number (95% Confidence Interval) [Proportion of participants]
    0.781
    0.2%
    0.734
    0.3%
    5. Secondary Outcome
    Title Overall Survival
    Description Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.
    Time Frame Baseline to Date of Death from Any Cause (up to 80.30 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Overall survival is censored at the last date of contact for participants who have no reported death. The number of censored participant data for enzastaurin and placebo is 404 (80.2%) and 205 (80.7%), respectively.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 504 254
    Minimum OS Survival
    0.03
    0.03
    Maximum OS Survival
    76.81
    80.30
    6. Secondary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events
    Description Number of participants with treatment-emergent adverse events.
    Time Frame First dose through 30 days post-study treatment discontinuation (up to 81.30 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 493 249
    Count of Participants [Participants]
    459
    91.1%
    230
    90.6%
    7. Secondary Outcome
    Title Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score
    Description The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.
    Time Frame Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who completed at least one FACT-Lym assessment.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 348 189
    Month 2
    2.45
    (0.67)
    1.86
    (0.93)
    Month 4
    2.56
    (0.80)
    2.51
    (1.06)
    Month 6
    2.04
    (0.87)
    2.82
    (1.10)
    Month 12
    3.85
    (0.87)
    2.11
    (1.29)
    Month 18
    2.87
    (0.89)
    1.73
    (1.26)
    Month 24
    2.72
    (0.99)
    3.96
    (1.26)
    Month 36
    2.54
    (1.13)
    4.22
    (1.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.606
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.971
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 6
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.580
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.265
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 18
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.460
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 24
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.441
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 36
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.357
    Comments
    Method Mixed Models Analysis
    Comments
    8. Secondary Outcome
    Title Change From Baseline in EuroQol-5D (EQ-5D) Score
    Description The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.
    Time Frame Baseline, Month 6; Baseline, Month 24; Baseline, Month 33

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who completed at least one EQ-5D assessment.
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Placebo administered PO QD after an initial loading dose of placebo on Day 1.
    Measure Participants 346 187
    Month 6
    0.02
    (0.01)
    0.00
    (0.01)
    Month 24
    0.02
    (0.01)
    0.03
    (0.02)
    Month 33
    0.03
    (0.01)
    0.03
    (0.01)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 6
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.267
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 24
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.807
    Comments
    Method Mixed Models Analysis
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments Analysis for Month 33
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.864
    Comments
    Method Mixed Models Analysis
    Comments
    9. Secondary Outcome
    Title Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells
    Description Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.
    Time Frame Baseline to 24 months (2 years)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.
    Arm/Group Title Enzastaurin: Arm A - Experimental With Germinal-center B-cells Enzastaurin: Arm A - Experimental Non-germinal-center B-cells Placebo: Arm B - Control With Germinal-center B-cells Placebo Arm B- Control With Non-germinal-center B-cells
    Arm/Group Description Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1.Participants from enzastaurin treatment group with diffuse large B-cell lymphoma expression profile similar to germinal-center B-cells. Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells Placebo administered PO QD after an initial loading dose of placebo on Day 1.Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells. Placebo administered PO QD after an initial loading dose of placebo on Day 1. Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells.
    Measure Participants 79 63 30 39
    Number (95% Confidence Interval) [percentage of participants]
    76.31
    15.1%
    75.97
    29.9%
    66.21
    8.7%
    68.20
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.400
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.768
    Confidence Interval (2-Sided) 95%
    0.415 to 1.420
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo: Arm B - Control With Germinal-center B-cells, Placebo Arm B- Control With Non-germinal-center B-cells
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.539
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.309
    Confidence Interval (2-Sided) 95%
    0.557 to 3.080
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression
    Description Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).
    Time Frame Baseline to 94.5 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.
    Arm/Group Title Enzastaurin: Arm A With PKC-β2 Cytoplasm (High Expression) Enzastaurin: Arm A With PKC-β2 Cytoplasm (Low Expression) Placebo: Arm B With PKC-β2 Cytoplasm (High Expression) Placebo: Arm B With PKC-β2 Cytoplasm (Low Expression)
    Arm/Group Description Participants from enzastaurin treatment groups with PKC-β2 cytoplasmic protein expression. Participants from enzastaurin treatment groups with PKC-β2 cytoplasmic protein expression. Participants from placebo treatment group with PKC-β2 cytoplasmic protein expression. Participants from placebo treatment group with PKC-β2 cytoplasmic protein expression.
    Measure Participants 39 117 21 50
    Number (95% Confidence Interval) [percentage of participants]
    64.86
    12.9%
    81.16
    32%
    61.54
    8.1%
    70.58
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzastaurin: Arm A - Experimental, Placebo: Arm B - Control With Germinal-center B-cells
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.084
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.775
    Confidence Interval (2-Sided) 95%
    0.947 to 3.329
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo: Arm B - Control, Placebo Arm B- Control With Non-germinal-center B-cells
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.585
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.286
    Confidence Interval (2-Sided) 95%
    0.527 to 3.137
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte
    Description
    Time Frame Month 2, Month 4: Predose

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of the study drug and had evaluable PK data.
    Arm/Group Title Total Enzastaurin Population
    Arm/Group Description All participants who received enzastaurin 500 mg PO QD after an initial loading dose of 1125 mg on Day 1.
    Measure Participants 328
    Geometric Mean (Geometric Coefficient of Variation) [nanomole/liter (nmol/L)]
    2370
    (59.9)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Arm/Group Description Administered orally as four 125-mg tablets daily (after an initial loading dose of three 125-mg tablets given three times on Day 1) Administered orally as four tablets daily (after an initial loading dose of three tablets given three times on Day 1)
    All Cause Mortality
    Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 135/493 (27.4%) 72/249 (28.9%)
    Blood and lymphatic system disorders
    Anaemia 5/493 (1%) 9 0/249 (0%) 0
    Febrile neutropenia 6/493 (1.2%) 6 3/249 (1.2%) 4
    Leukopenia 1/493 (0.2%) 1 1/249 (0.4%) 1
    Lymphadenopathy 0/493 (0%) 0 1/249 (0.4%) 1
    Neutropenia 3/493 (0.6%) 3 2/249 (0.8%) 2
    Cardiac disorders
    Acute coronary syndrome 0/493 (0%) 0 1/249 (0.4%) 2
    Angina pectoris 1/493 (0.2%) 1 0/249 (0%) 0
    Angina unstable 1/493 (0.2%) 1 0/249 (0%) 0
    Arrhythmia 1/493 (0.2%) 1 0/249 (0%) 0
    Atrial fibrillation 0/493 (0%) 0 2/249 (0.8%) 15
    Atrial flutter 0/493 (0%) 0 1/249 (0.4%) 1
    Atrioventricular block complete 1/493 (0.2%) 11 1/249 (0.4%) 1
    Bradycardia 0/493 (0%) 0 1/249 (0.4%) 1
    Cardiac arrest 2/493 (0.4%) 2 1/249 (0.4%) 3
    Cardiac failure 3/493 (0.6%) 16 2/249 (0.8%) 2
    Cardiac failure chronic 1/493 (0.2%) 1 0/249 (0%) 0
    Cardiac failure congestive 1/493 (0.2%) 2 2/249 (0.8%) 4
    Cardio-respiratory arrest 0/493 (0%) 0 1/249 (0.4%) 1
    Cardiomyopathy 3/493 (0.6%) 25 0/249 (0%) 0
    Coronary artery disease 1/493 (0.2%) 1 0/249 (0%) 0
    Coronary artery stenosis 0/493 (0%) 0 1/249 (0.4%) 1
    Left ventricular dysfunction 1/493 (0.2%) 6 1/249 (0.4%) 1
    Myocardial infarction 1/493 (0.2%) 1 1/249 (0.4%) 1
    Myocardial ischaemia 1/493 (0.2%) 1 1/249 (0.4%) 3
    Sick sinus syndrome 1/493 (0.2%) 1 0/249 (0%) 0
    Sinus bradycardia 1/493 (0.2%) 2 0/249 (0%) 0
    Torsade de pointes 0/493 (0%) 0 1/249 (0.4%) 1
    Ventricular fibrillation 1/493 (0.2%) 1 0/249 (0%) 0
    Ventricular tachycardia 0/493 (0%) 0 1/249 (0.4%) 1
    Ear and labyrinth disorders
    Vertigo 1/493 (0.2%) 8 0/249 (0%) 0
    Eye disorders
    Cataract 2/493 (0.4%) 4 2/249 (0.8%) 2
    Conjunctival haemorrhage 1/493 (0.2%) 2 0/249 (0%) 0
    Eyelid ptosis 1/493 (0.2%) 5 1/249 (0.4%) 6
    Ophthalmoplegia 0/493 (0%) 0 1/249 (0.4%) 2
    Retinal detachment 1/493 (0.2%) 2 0/249 (0%) 0
    Retinal vein occlusion 0/493 (0%) 0 1/249 (0.4%) 1
    Vision blurred 1/493 (0.2%) 1 0/249 (0%) 0
    Gastrointestinal disorders
    Abdominal pain upper 1/493 (0.2%) 2 0/249 (0%) 0
    Anal prolapse 0/493 (0%) 0 1/249 (0.4%) 2
    Colitis 1/493 (0.2%) 1 1/249 (0.4%) 1
    Colonic polyp 1/493 (0.2%) 1 0/249 (0%) 0
    Constipation 1/493 (0.2%) 1 0/249 (0%) 0
    Diarrhoea 3/493 (0.6%) 3 0/249 (0%) 0
    Dysphagia 0/493 (0%) 0 2/249 (0.8%) 17
    Food poisoning 0/493 (0%) 0 1/249 (0.4%) 1
    Gastritis 1/493 (0.2%) 13 0/249 (0%) 0
    Gastrointestinal obstruction 0/493 (0%) 0 1/249 (0.4%) 1
    Gingivitis ulcerative 1/493 (0.2%) 3 0/249 (0%) 0
    Haemorrhoids 2/493 (0.4%) 3 0/249 (0%) 0
    Ileus 2/493 (0.4%) 3 0/249 (0%) 0
    Ileus paralytic 0/493 (0%) 0 1/249 (0.4%) 1
    Inguinal hernia 2/493 (0.4%) 2 1/249 (0.4%) 1
    Intestinal obstruction 0/493 (0%) 0 1/249 (0.4%) 1
    Jejunal perforation 1/493 (0.2%) 1 0/249 (0%) 0
    Nausea 1/493 (0.2%) 1 0/249 (0%) 0
    Oral lichen planus 1/493 (0.2%) 11 0/249 (0%) 0
    Pancreatitis 1/493 (0.2%) 1 0/249 (0%) 0
    Pancreatitis acute 1/493 (0.2%) 2 1/249 (0.4%) 1
    Pseudopolyposis 1/493 (0.2%) 1 0/249 (0%) 0
    Small intestinal obstruction 1/493 (0.2%) 2 1/249 (0.4%) 2
    Subileus 0/493 (0%) 0 1/249 (0.4%) 1
    Umbilical hernia 0/493 (0%) 0 1/249 (0.4%) 1
    Volvulus of small bowel 1/493 (0.2%) 1 0/249 (0%) 0
    Vomiting 2/493 (0.4%) 2 1/249 (0.4%) 15
    General disorders
    Asthenia 2/493 (0.4%) 4 1/249 (0.4%) 2
    Chest pain 2/493 (0.4%) 2 1/249 (0.4%) 1
    Death 1/493 (0.2%) 1 0/249 (0%) 0
    General physical health deterioration 1/493 (0.2%) 2 0/249 (0%) 0
    Multi-organ disorder 0/493 (0%) 0 1/249 (0.4%) 3
    Multi-organ failure 0/493 (0%) 0 1/249 (0.4%) 1
    Pain 1/493 (0.2%) 2 0/249 (0%) 0
    Spinal pain 1/493 (0.2%) 1 0/249 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 3/493 (0.6%) 4 0/249 (0%) 0
    Cholecystitis acute 1/493 (0.2%) 1 0/249 (0%) 0
    Cholelithiasis 4/493 (0.8%) 6 0/249 (0%) 0
    Hepatic cirrhosis 1/493 (0.2%) 7 0/249 (0%) 0
    Hepatic function abnormal 1/493 (0.2%) 1 0/249 (0%) 0
    Hepatotoxicity 1/493 (0.2%) 2 0/249 (0%) 0
    Immune system disorders
    Allergy to arthropod sting 1/493 (0.2%) 1 0/249 (0%) 0
    Contrast media allergy 0/493 (0%) 0 2/249 (0.8%) 2
    Infections and infestations
    Abdominal sepsis 1/493 (0.2%) 1 0/249 (0%) 0
    Arthritis infective 1/493 (0.2%) 1 0/249 (0%) 0
    Beta haemolytic streptococcal infection 1/493 (0.2%) 1 0/249 (0%) 0
    Bronchitis 1/493 (0.2%) 2 0/249 (0%) 0
    Bronchopneumonia 0/493 (0%) 0 1/249 (0.4%) 1
    Bronchopulmonary aspergillosis 0/493 (0%) 0 1/249 (0.4%) 2
    Cellulitis 2/493 (0.4%) 3 0/249 (0%) 0
    Cervicitis 1/239 (0.4%) 1 0/249 (0%) 0
    Clostridium difficile colitis 1/493 (0.2%) 1 0/249 (0%) 0
    Enteritis infectious 0/493 (0%) 0 1/249 (0.4%) 1
    Enterocolitis infectious 1/493 (0.2%) 1 0/249 (0%) 0
    Escherichia sepsis 1/493 (0.2%) 1 0/249 (0%) 0
    Escherichia urinary tract infection 0/493 (0%) 0 1/249 (0.4%) 1
    Gastroenteritis 1/493 (0.2%) 1 0/249 (0%) 0
    Helicobacter gastritis 0/493 (0%) 0 2/249 (0.8%) 3
    Hepatic cyst infection 0/493 (0%) 0 1/249 (0.4%) 2
    Hepatitis b 0/493 (0%) 0 3/249 (1.2%) 11
    Hepatitis c 1/493 (0.2%) 7 0/249 (0%) 0
    Herpes zoster 1/493 (0.2%) 1 0/249 (0%) 0
    Infection 0/493 (0%) 0 1/249 (0.4%) 1
    Infectious peritonitis 1/493 (0.2%) 1 0/249 (0%) 0
    Intervertebral discitis 1/493 (0.2%) 11 0/249 (0%) 0
    Lobar pneumonia 1/493 (0.2%) 2 0/249 (0%) 0
    Lung infection 2/493 (0.4%) 2 0/249 (0%) 0
    Myelitis 0/493 (0%) 0 1/249 (0.4%) 10
    Necrotising fasciitis 0/493 (0%) 0 1/249 (0.4%) 1
    Neutropenic infection 1/493 (0.2%) 1 0/249 (0%) 0
    Periodontitis 1/493 (0.2%) 2 0/249 (0%) 0
    Pneumonia 6/493 (1.2%) 7 7/249 (2.8%) 10
    Pseudomembranous colitis 1/493 (0.2%) 1 0/249 (0%) 0
    Pseudomonal bacteraemia 0/493 (0%) 0 1/249 (0.4%) 1
    Pyelonephritis 1/493 (0.2%) 2 0/249 (0%) 0
    Respiratory tract infection 0/493 (0%) 0 1/249 (0.4%) 2
    Scrub typhus 0/493 (0%) 0 1/249 (0.4%) 1
    Sepsis 5/493 (1%) 7 1/249 (0.4%) 1
    Septic shock 1/493 (0.2%) 2 0/249 (0%) 0
    Staphylococcal infection 0/493 (0%) 0 1/249 (0.4%) 1
    Urinary tract infection 3/493 (0.6%) 5 0/249 (0%) 0
    Urosepsis 2/493 (0.4%) 3 0/249 (0%) 0
    Viral upper respiratory tract infection 1/493 (0.2%) 1 0/249 (0%) 0
    Wound infection 0/493 (0%) 0 1/249 (0.4%) 1
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/493 (0.2%) 2 0/249 (0%) 0
    Ankle fracture 0/493 (0%) 0 1/249 (0.4%) 2
    Cervical vertebral fracture 1/493 (0.2%) 1 0/249 (0%) 0
    Concussion 1/493 (0.2%) 1 0/249 (0%) 0
    Fall 0/493 (0%) 0 2/249 (0.8%) 3
    Hip fracture 1/493 (0.2%) 12 1/249 (0.4%) 1
    Lumbar vertebral fracture 1/493 (0.2%) 1 0/249 (0%) 0
    Maternal exposure during pregnancy 2/239 (0.8%) 8 0/249 (0%) 0
    Radius fracture 0/493 (0%) 0 1/249 (0.4%) 1
    Road traffic accident 1/493 (0.2%) 1 0/249 (0%) 0
    Spinal compression fracture 1/493 (0.2%) 7 1/249 (0.4%) 17
    Subdural haematoma 1/493 (0.2%) 2 0/249 (0%) 0
    Tendon rupture 0/493 (0%) 0 1/249 (0.4%) 10
    Tibia fracture 1/493 (0.2%) 6 0/249 (0%) 0
    Investigations
    Aspartate aminotransferase increased 1/493 (0.2%) 3 0/249 (0%) 0
    Ejection fraction decreased 1/493 (0.2%) 1 1/249 (0.4%) 3
    Electrocardiogram abnormal 1/493 (0.2%) 1 0/249 (0%) 0
    Electrocardiogram qt prolonged 3/493 (0.6%) 12 1/249 (0.4%) 2
    Metabolism and nutrition disorders
    Decreased appetite 0/493 (0%) 0 1/249 (0.4%) 2
    Dehydration 1/493 (0.2%) 1 1/249 (0.4%) 1
    Hypoglycaemia 2/493 (0.4%) 2 0/249 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/493 (0.2%) 1 0/249 (0%) 0
    Back pain 2/493 (0.4%) 2 2/249 (0.8%) 4
    Haemarthrosis 1/493 (0.2%) 6 0/249 (0%) 0
    Intervertebral disc protrusion 0/493 (0%) 0 1/249 (0.4%) 12
    Myalgia 1/493 (0.2%) 1 0/249 (0%) 0
    Neck pain 1/493 (0.2%) 1 0/249 (0%) 0
    Osteoarthritis 1/493 (0.2%) 1 2/249 (0.8%) 21
    Osteolysis 1/493 (0.2%) 2 0/249 (0%) 0
    Pain in extremity 1/493 (0.2%) 1 0/249 (0%) 0
    Plantar fasciitis 1/493 (0.2%) 1 0/249 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 0/493 (0%) 0 1/249 (0.4%) 1
    Basal cell carcinoma 1/493 (0.2%) 11 0/249 (0%) 0
    Breast cancer in situ 1/493 (0.2%) 1 0/249 (0%) 0
    Cerebellar tumour 1/493 (0.2%) 3 0/249 (0%) 0
    Colon adenoma 1/493 (0.2%) 1 0/249 (0%) 0
    Colon cancer 1/493 (0.2%) 9 1/249 (0.4%) 14
    Diffuse large b-cell lymphoma 0/493 (0%) 0 1/249 (0.4%) 3
    Gastric cancer 2/493 (0.4%) 4 0/249 (0%) 0
    Hepatic cancer metastatic 1/493 (0.2%) 9 0/249 (0%) 0
    Hypopharyngeal cancer 1/493 (0.2%) 2 0/249 (0%) 0
    Large intestine carcinoma 1/493 (0.2%) 1 0/249 (0%) 0
    Lung neoplasm 0/493 (0%) 0 1/249 (0.4%) 10
    Lung neoplasm malignant 2/493 (0.4%) 7 0/249 (0%) 0
    Multiple myeloma 1/493 (0.2%) 6 0/249 (0%) 0
    Myelodysplastic syndrome 0/493 (0%) 0 1/249 (0.4%) 3
    Ovarian neoplasm 1/239 (0.4%) 1 0/249 (0%) 0
    Pancreatic neoplasm 1/493 (0.2%) 5 0/249 (0%) 0
    Prostate cancer 1/254 (0.4%) 5 0/249 (0%) 0
    Rectal cancer 1/493 (0.2%) 9 1/249 (0.4%) 1
    Salivary gland adenoma 1/493 (0.2%) 4 0/249 (0%) 0
    Squamous cell carcinoma 1/493 (0.2%) 18 0/249 (0%) 0
    Thyroid neoplasm 1/493 (0.2%) 1 0/249 (0%) 0
    Nervous system disorders
    Basal ganglia infarction 1/493 (0.2%) 2 0/249 (0%) 0
    Cerebral haemorrhage 2/493 (0.4%) 2 0/249 (0%) 0
    Convulsion 1/493 (0.2%) 1 0/249 (0%) 0
    Cranial nerve paralysis 0/493 (0%) 0 1/249 (0.4%) 2
    Dysaesthesia 0/493 (0%) 0 1/249 (0.4%) 6
    Epilepsy 0/493 (0%) 0 1/249 (0.4%) 2
    Grand mal convulsion 2/493 (0.4%) 2 0/249 (0%) 0
    Headache 1/493 (0.2%) 1 1/249 (0.4%) 15
    Hypoaesthesia 0/493 (0%) 0 1/249 (0.4%) 15
    Hypoxic-ischaemic encephalopathy 1/493 (0.2%) 1 0/249 (0%) 0
    Ischaemic stroke 1/493 (0.2%) 1 0/249 (0%) 0
    Nerve root compression 1/493 (0.2%) 4 0/249 (0%) 0
    Neuropathy peripheral 0/493 (0%) 0 1/249 (0.4%) 9
    Posterior reversible encephalopathy syndrome 1/493 (0.2%) 1 0/249 (0%) 0
    Sciatica 1/493 (0.2%) 3 1/249 (0.4%) 3
    Syncope 6/493 (1.2%) 8 0/249 (0%) 0
    Tongue paralysis 0/493 (0%) 0 1/249 (0.4%) 15
    Tonic convulsion 1/493 (0.2%) 1 0/249 (0%) 0
    Transient ischaemic attack 0/493 (0%) 0 2/249 (0.8%) 3
    Vith nerve paralysis 1/493 (0.2%) 2 0/249 (0%) 0
    Vocal cord paralysis 0/493 (0%) 0 1/249 (0.4%) 2
    Psychiatric disorders
    Delirium 1/493 (0.2%) 2 0/249 (0%) 0
    Depression 1/493 (0.2%) 14 0/249 (0%) 0
    Renal and urinary disorders
    Calculus ureteric 1/493 (0.2%) 6 0/249 (0%) 0
    Hydronephrosis 1/493 (0.2%) 3 0/249 (0%) 0
    Incontinence 1/493 (0.2%) 1 0/249 (0%) 0
    Oliguria 1/493 (0.2%) 2 0/249 (0%) 0
    Renal failure 2/493 (0.4%) 4 1/249 (0.4%) 1
    Renal failure acute 2/493 (0.4%) 2 0/249 (0%) 0
    Renal pain 1/493 (0.2%) 1 0/249 (0%) 0
    Urinary retention 0/493 (0%) 0 1/249 (0.4%) 1
    Reproductive system and breast disorders
    Prostatic obstruction 1/254 (0.4%) 12 0/249 (0%) 0
    Prostatitis 1/254 (0.4%) 1 0/249 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 0/493 (0%) 0 1/249 (0.4%) 6
    Asthma 0/493 (0%) 0 1/249 (0.4%) 1
    Dyspnoea 2/493 (0.4%) 4 1/249 (0.4%) 2
    Interstitial lung disease 1/493 (0.2%) 2 0/249 (0%) 0
    Lung infiltration 1/493 (0.2%) 8 0/249 (0%) 0
    Pleural effusion 0/493 (0%) 0 1/249 (0.4%) 1
    Pleurisy 3/493 (0.6%) 4 0/249 (0%) 0
    Pneumonitis 1/493 (0.2%) 5 0/249 (0%) 0
    Pulmonary embolism 8/493 (1.6%) 23 2/249 (0.8%) 2
    Skin and subcutaneous tissue disorders
    Dermal cyst 1/493 (0.2%) 1 0/249 (0%) 0
    Skin fibrosis 1/493 (0.2%) 1 0/249 (0%) 0
    Skin ulcer 1/493 (0.2%) 8 0/249 (0%) 0
    Surgical and medical procedures
    Abdominal hernia repair 1/493 (0.2%) 2 0/249 (0%) 0
    Anal fissure excision 1/493 (0.2%) 1 0/249 (0%) 0
    Meniscus removal 0/493 (0%) 0 1/249 (0.4%) 1
    Spinal fusion surgery 1/493 (0.2%) 2 0/249 (0%) 0
    Vascular disorders
    Aortic aneurysm 1/493 (0.2%) 9 0/249 (0%) 0
    Deep vein thrombosis 4/493 (0.8%) 21 0/249 (0%) 0
    Hypotension 1/493 (0.2%) 4 0/249 (0%) 0
    Thrombosis 0/493 (0%) 0 1/249 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Enzastaurin: Arm A - Experimental Placebo: Arm B - Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 406/493 (82.4%) 185/249 (74.3%)
    Blood and lymphatic system disorders
    Anaemia 33/493 (6.7%) 221 13/249 (5.2%) 79
    Leukopenia 27/493 (5.5%) 87 11/249 (4.4%) 45
    Neutropenia 52/493 (10.5%) 143 26/249 (10.4%) 66
    Gastrointestinal disorders
    Abdominal pain 40/493 (8.1%) 140 12/249 (4.8%) 20
    Constipation 49/493 (9.9%) 256 20/249 (8%) 101
    Diarrhoea 97/493 (19.7%) 387 33/249 (13.3%) 115
    Dry mouth 25/493 (5.1%) 177 5/249 (2%) 44
    Faeces discoloured 39/493 (7.9%) 340 0/249 (0%) 0
    Nausea 73/493 (14.8%) 195 38/249 (15.3%) 150
    Vomiting 47/493 (9.5%) 64 26/249 (10.4%) 44
    General disorders
    Fatigue 91/493 (18.5%) 628 45/249 (18.1%) 304
    Oedema peripheral 63/493 (12.8%) 370 16/249 (6.4%) 84
    Pyrexia 34/493 (6.9%) 60 16/249 (6.4%) 21
    Infections and infestations
    Nasopharyngitis 37/493 (7.5%) 112 13/249 (5.2%) 34
    Upper respiratory tract infection 42/493 (8.5%) 80 15/249 (6%) 47
    Urinary tract infection 27/493 (5.5%) 93 7/249 (2.8%) 13
    Investigations
    Alanine aminotransferase increased 27/493 (5.5%) 148 12/249 (4.8%) 73
    Aspartate aminotransferase increased 29/493 (5.9%) 191 12/249 (4.8%) 52
    Electrocardiogram qt prolonged 54/493 (11%) 317 11/249 (4.4%) 44
    Weight increased 24/493 (4.9%) 194 19/249 (7.6%) 149
    Metabolism and nutrition disorders
    Decreased appetite 34/493 (6.9%) 151 14/249 (5.6%) 56
    Musculoskeletal and connective tissue disorders
    Arthralgia 43/493 (8.7%) 368 28/249 (11.2%) 238
    Back pain 52/493 (10.5%) 353 24/249 (9.6%) 213
    Musculoskeletal pain 32/493 (6.5%) 263 15/249 (6%) 107
    Pain in extremity 36/493 (7.3%) 173 17/249 (6.8%) 71
    Nervous system disorders
    Dizziness 53/493 (10.8%) 238 21/249 (8.4%) 129
    Headache 49/493 (9.9%) 295 32/249 (12.9%) 189
    Psychiatric disorders
    Insomnia 40/493 (8.1%) 327 13/249 (5.2%) 107
    Renal and urinary disorders
    Chromaturia 96/493 (19.5%) 916 1/249 (0.4%) 13
    Respiratory, thoracic and mediastinal disorders
    Cough 76/493 (15.4%) 283 30/249 (12%) 130
    Oropharyngeal pain 26/493 (5.3%) 84 7/249 (2.8%) 14
    Skin and subcutaneous tissue disorders
    Pruritus 51/493 (10.3%) 329 21/249 (8.4%) 104
    Rash 56/493 (11.4%) 323 27/249 (10.8%) 120
    Vascular disorders
    Hypertension 8/493 (1.6%) 64 13/249 (5.2%) 127

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00332202
    Other Study ID Numbers:
    • 9823
    • H6Q-MC-JCBJ
    • PRELUDE
    First Posted:
    Jun 1, 2006
    Last Update Posted:
    Sep 10, 2018
    Last Verified:
    Sep 1, 2018