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A Study of Tasisulam in Treating Participants With Malignant Melanoma

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00383292
Collaborator
(none)
130
Enrollment
13
Locations
1
Arm
104
Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tasisulam

Drug: tasisulam
Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.
Other Names:
  • LY573636

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response) [Baseline to Measured Progressive Disease (up to 60 Months)]

      Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)]

      PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.

    2. Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate) [Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)]

      Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.

    3. Pharmacokinetics: Plasma Clearance Rate of Tasisulam [Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion]

    4. Overall Survival (OS) Time [Baseline to Death from Any Cause (up to 42 Months)]

      OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

    5. Duration of Overall Objective Response [Date of Response to Date of Measured PD (up to 1 Year)]

      The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.

    6. Duration of Stable Disease (SD) [Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)]

      Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.

    7. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events) [Baseline to Study Completion (up to 60 Months)]

      Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

    8. Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score [Baseline to Study Completion (up to 60 Months)]

      FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.

    Eligibility Criteria

    Criteria

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

    • Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)

    • Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.

    • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

    Exclusion Criteria:

    • Serious pre-existing medical conditions

    • Have received two or more previous treatment regimens for unresectable or metastatic melanoma

    • Have a second primary cancer (unless disease-free to more than 2 years)

    • Active treatment with Warfarin (Coumadin)

    • Primary ocular or mucosal melanoma

    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. Los Angeles California United States 90025
    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. Aurora Colorado United States 80045
    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. Lakeland Florida United States 33805
    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. Indianapolis Indiana United States 46202
    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. Rochester Minnesota United States 55905
    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. Albuquerque New Mexico United States 87131
    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. Pittsburgh Pennsylvania United States 15232
    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. Memphis Tennessee United States 38138
    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. Coffs Harbour New South Wales Australia 2450
    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. Wollongong New South Wales Australia 2500
    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. Adelaide South Australia Australia 5000
    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. Ashford South Australia Australia 5035
    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. Nedlands Western Australia Australia 6009

    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:
    NCT00383292
    Other Study ID Numbers:
    • 10409
    • H8K-MC-JZAF
    First Posted:
    Oct 3, 2006
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    May 1, 2018
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    Participant Flow

    Recruitment Details Interim analyses of pharmacokinetic (PK) data resulted in adjusted dosing populations to achieve desired concentrations of study drug within the targeted range.
    Pre-assignment Detail Study completion was defined as a participant completing 2 cycles of treatment and end of Cycle 2 radiographic assessment of response.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Period Title: Overall Study
    STARTED 68 32 30
    Received at Least One Dose of Study Drug 68 32 30
    COMPLETED 53 26 22
    NOT COMPLETED 15 6 8

    Baseline Characteristics

    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose Total
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks). Total of all reporting groups
    Overall Participants 68 32 30 130
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    58.03
    (12.68)
    61.60
    (15.89)
    61.35
    (11.69)
    59.67
    (13.34)
    Sex: Female, Male (Count of Participants)
    Female
    26
    38.2%
    10
    31.3%
    9
    30%
    45
    34.6%
    Male
    42
    61.8%
    22
    68.8%
    21
    70%
    85
    65.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    3.1%
    0
    0%
    1
    0.8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    1.5%
    0
    0%
    0
    0%
    1
    0.8%
    White
    67
    98.5%
    31
    96.9%
    30
    100%
    128
    98.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    39
    57.4%
    25
    78.1%
    26
    86.7%
    90
    69.2%
    Australia
    29
    42.6%
    7
    21.9%
    4
    13.3%
    40
    30.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)
    Description Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
    Time Frame Baseline to Measured Progressive Disease (up to 60 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Number (90% Confidence Interval) [Percentage of Participants]
    10
    14.7%
    6
    18.8%
    7
    23.3%
    2. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
    Time Frame Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Median (95% Confidence Interval) [Months]
    2.8
    2.8
    3.5
    3. Secondary Outcome
    Title Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)
    Description Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.
    Time Frame Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Number (90% Confidence Interval) [Percentage of Participants]
    47
    69.1%
    47
    146.9%
    50
    166.7%
    4. Secondary Outcome
    Title Pharmacokinetics: Plasma Clearance Rate of Tasisulam
    Description
    Time Frame Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol.
    Arm/Group Title Tasisulam
    Arm/Group Description Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Participants will receive a 2-hour intravenous infusion of study drug once every 28 days.
    Measure Participants 127
    Geometric Mean (Standard Error) [Liters/hour (L/h)]
    0.0275
    (3.57)
    5. Secondary Outcome
    Title Overall Survival (OS) Time
    Description OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.
    Time Frame Baseline to Death from Any Cause (up to 42 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Median (95% Confidence Interval) [Months]
    10.5
    11.9
    20.1
    6. Secondary Outcome
    Title Duration of Overall Objective Response
    Description The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.
    Time Frame Date of Response to Date of Measured PD (up to 1 Year)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Median (95% Confidence Interval) [Months]
    5.6
    7.2
    4.1
    7. Secondary Outcome
    Title Duration of Stable Disease (SD)
    Description Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.
    Time Frame Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Median (95% Confidence Interval) [Months]
    6.9
    6.4
    5.7
    8. Secondary Outcome
    Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)
    Description Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
    Time Frame Baseline to Study Completion (up to 60 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug.
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    Measure Participants 68 32 30
    Count of Participants [Participants]
    13
    19.1%
    6
    18.8%
    6
    20%
    9. Secondary Outcome
    Title Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score
    Description FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.
    Time Frame Baseline to Study Completion (up to 60 Months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol.
    Arm/Group Title Tasisulam
    Arm/Group Description Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Participants will receive a 2-hour intravenous infusion of study drug once every 28 days.
    Measure Participants 127
    Mean (Standard Deviation) [Units on a Scale]
    80.76
    (15.03)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Arm/Group Description Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks). Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).
    All Cause Mortality
    Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/68 (35.3%) 13/32 (40.6%) 11/30 (36.7%)
    Blood and lymphatic system disorders
    Anaemia 5/68 (7.4%) 11 2/32 (6.3%) 3 2/30 (6.7%) 2
    Febrile neutropenia 2/68 (2.9%) 2 1/32 (3.1%) 1 0/30 (0%) 0
    Leukopenia 1/68 (1.5%) 2 0/32 (0%) 0 1/30 (3.3%) 1
    Neutropenia 6/68 (8.8%) 9 1/32 (3.1%) 2 4/30 (13.3%) 6
    Thrombocytopenia 7/68 (10.3%) 12 3/32 (9.4%) 4 4/30 (13.3%) 4
    Cardiac disorders
    Atrial fibrillation 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Cardiac ventricular thrombosis 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Cardiogenic shock 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Sinus tachycardia 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Supraventricular tachycardia 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    Acute abdomen 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Gastrointestinal haemorrhage 1/68 (1.5%) 1 1/32 (3.1%) 1 0/30 (0%) 0
    Haematemesis 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Ileus 1/68 (1.5%) 1 0/32 (0%) 0 1/30 (3.3%) 1
    Intestinal obstruction 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Melaena 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    Pancreatitis acute 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Small intestinal obstruction 1/68 (1.5%) 1 0/32 (0%) 0 1/30 (3.3%) 1
    Upper gastrointestinal haemorrhage 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    General disorders
    Asthenia 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Chest pain 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Fatigue 2/68 (2.9%) 2 0/32 (0%) 0 0/30 (0%) 0
    Mucosal inflammation 2/68 (2.9%) 4 0/32 (0%) 0 0/30 (0%) 0
    Multi-organ failure 2/68 (2.9%) 2 0/32 (0%) 0 0/30 (0%) 0
    Oedema peripheral 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Infections and infestations
    Bacteraemia 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Bacterial infection 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Biliary tract infection 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    Cellulitis 2/68 (2.9%) 2 1/32 (3.1%) 1 0/30 (0%) 0
    Herpes zoster 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Paronychia 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Pneumonia 3/68 (4.4%) 4 2/32 (6.3%) 2 3/30 (10%) 4
    Sepsis 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Urinary tract infection 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    Injury, poisoning and procedural complications
    Procedural complication 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Investigations
    Blood bilirubin increased 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Haemoglobin decreased 2/68 (2.9%) 9 0/32 (0%) 0 1/30 (3.3%) 1
    Metabolism and nutrition disorders
    Decreased appetite 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Dehydration 2/68 (2.9%) 2 0/32 (0%) 0 0/30 (0%) 0
    Hyperkalaemia 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Musculoskeletal and connective tissue disorders
    Joint swelling 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Muscular weakness 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Nervous system disorders
    Aphasia 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Cerebral artery thrombosis 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Haemorrhagic stroke 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 1
    Peripheral motor neuropathy 1/68 (1.5%) 2 0/32 (0%) 0 0/30 (0%) 0
    Spinal cord compression 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Hydronephrosis 2/68 (2.9%) 2 0/32 (0%) 0 0/30 (0%) 0
    Renal failure 2/68 (2.9%) 2 0/32 (0%) 0 0/30 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Dyspnoea 0/68 (0%) 0 1/32 (3.1%) 1 1/30 (3.3%) 1
    Pleural effusion 1/68 (1.5%) 1 0/32 (0%) 0 0/30 (0%) 0
    Pneumonia aspiration 0/68 (0%) 0 1/32 (3.1%) 1 0/30 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash 0/68 (0%) 0 0/32 (0%) 0 1/30 (3.3%) 3
    Vascular disorders
    Hypotension 3/68 (4.4%) 3 0/32 (0%) 0 0/30 (0%) 0
    Other (Not Including Serious) Adverse Events
    Tasisulam Dose Target 420 μg/mL Cmax Tasisulam Dose Target 360 μg/mL Cmax Tasisulam Albumin-Tailored Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 58/68 (85.3%) 31/32 (96.9%) 29/30 (96.7%)
    Blood and lymphatic system disorders
    Anaemia 11/68 (16.2%) 100 4/32 (12.5%) 21 5/30 (16.7%) 34
    Leukopenia 5/68 (7.4%) 46 0/32 (0%) 0 0/30 (0%) 0
    Lymphopenia 1/68 (1.5%) 1 0/32 (0%) 0 2/30 (6.7%) 4
    Neutropenia 9/68 (13.2%) 36 6/32 (18.8%) 25 2/30 (6.7%) 6
    Thrombocytopenia 13/68 (19.1%) 62 7/32 (21.9%) 19 11/30 (36.7%) 48
    Cardiac disorders
    Tachycardia 1/68 (1.5%) 2 0/32 (0%) 0 2/30 (6.7%) 2
    Eye disorders
    Vision blurred 4/68 (5.9%) 15 1/32 (3.1%) 3 0/30 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 10/68 (14.7%) 25 5/32 (15.6%) 22 7/30 (23.3%) 25
    Abdominal pain upper 2/68 (2.9%) 8 1/32 (3.1%) 12 3/30 (10%) 20
    Constipation 14/68 (20.6%) 45 9/32 (28.1%) 22 4/30 (13.3%) 15
    Diarrhoea 20/68 (29.4%) 62 14/32 (43.8%) 67 10/30 (33.3%) 21
    Dyspepsia 8/68 (11.8%) 59 2/32 (6.3%) 2 2/30 (6.7%) 9
    Gastrooesophageal reflux disease 2/68 (2.9%) 50 0/32 (0%) 0 2/30 (6.7%) 12
    Nausea 17/68 (25%) 74 12/32 (37.5%) 38 5/30 (16.7%) 9
    Stomatitis 5/68 (7.4%) 8 6/32 (18.8%) 43 2/30 (6.7%) 3
    Vomiting 7/68 (10.3%) 9 5/32 (15.6%) 15 2/30 (6.7%) 3
    General disorders
    Asthenia 2/68 (2.9%) 5 3/32 (9.4%) 6 1/30 (3.3%) 15
    Axillary pain 0/68 (0%) 0 2/32 (6.3%) 11 0/30 (0%) 0
    Chest pain 2/68 (2.9%) 4 4/32 (12.5%) 5 2/30 (6.7%) 4
    Fatigue 27/68 (39.7%) 249 16/32 (50%) 94 11/30 (36.7%) 71
    Infusion site pain 8/68 (11.8%) 14 3/32 (9.4%) 3 6/30 (20%) 8
    Injection site pain 2/68 (2.9%) 2 2/32 (6.3%) 2 1/30 (3.3%) 1
    Mucosal inflammation 3/68 (4.4%) 11 0/32 (0%) 0 4/30 (13.3%) 4
    Oedema peripheral 6/68 (8.8%) 56 2/32 (6.3%) 13 6/30 (20%) 36
    Pain 3/68 (4.4%) 19 3/32 (9.4%) 23 2/30 (6.7%) 10
    Pyrexia 0/68 (0%) 0 3/32 (9.4%) 3 4/30 (13.3%) 6
    Infections and infestations
    Herpes zoster 3/68 (4.4%) 12 3/32 (9.4%) 16 1/30 (3.3%) 1
    Upper respiratory tract infection 3/68 (4.4%) 9 0/32 (0%) 0 2/30 (6.7%) 4
    Urinary tract infection 0/68 (0%) 0 2/32 (6.3%) 3 2/30 (6.7%) 12
    Injury, poisoning and procedural complications
    Contusion 3/68 (4.4%) 6 5/32 (15.6%) 18 0/30 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/68 (1.5%) 1 0/32 (0%) 0 2/30 (6.7%) 3
    Aspartate aminotransferase increased 1/68 (1.5%) 1 0/32 (0%) 0 2/30 (6.7%) 5
    Blood alkaline phosphatase increased 2/68 (2.9%) 6 1/32 (3.1%) 6 2/30 (6.7%) 20
    Blood creatinine increased 4/68 (5.9%) 20 2/32 (6.3%) 11 2/30 (6.7%) 6
    Haemoglobin decreased 2/68 (2.9%) 13 3/32 (9.4%) 8 1/30 (3.3%) 6
    Platelet count decreased 4/68 (5.9%) 5 3/32 (9.4%) 4 1/30 (3.3%) 3
    Weight decreased 3/68 (4.4%) 20 3/32 (9.4%) 15 2/30 (6.7%) 15
    White blood cell count decreased 1/68 (1.5%) 2 2/32 (6.3%) 11 1/30 (3.3%) 1
    Metabolism and nutrition disorders
    Decreased appetite 7/68 (10.3%) 22 5/32 (15.6%) 20 3/30 (10%) 19
    Dehydration 5/68 (7.4%) 13 2/32 (6.3%) 6 2/30 (6.7%) 2
    Hypoalbuminaemia 5/68 (7.4%) 24 0/32 (0%) 0 3/30 (10%) 11
    Hypokalaemia 9/68 (13.2%) 46 6/32 (18.8%) 32 0/30 (0%) 0
    Hypomagnesaemia 4/68 (5.9%) 21 0/32 (0%) 0 0/30 (0%) 0
    Hyponatraemia 6/68 (8.8%) 13 0/32 (0%) 0 3/30 (10%) 9
    Hypophosphataemia 4/68 (5.9%) 15 0/32 (0%) 0 3/30 (10%) 5
    Musculoskeletal and connective tissue disorders
    Arthralgia 7/68 (10.3%) 100 3/32 (9.4%) 6 2/30 (6.7%) 9
    Back pain 4/68 (5.9%) 45 4/32 (12.5%) 6 1/30 (3.3%) 7
    Muscle spasms 4/68 (5.9%) 4 1/32 (3.1%) 14 0/30 (0%) 0
    Muscular weakness 3/68 (4.4%) 17 2/32 (6.3%) 4 1/30 (3.3%) 14
    Musculoskeletal pain 5/68 (7.4%) 30 0/32 (0%) 0 0/30 (0%) 0
    Myalgia 5/68 (7.4%) 20 4/32 (12.5%) 11 2/30 (6.7%) 5
    Neck pain 4/68 (5.9%) 17 2/32 (6.3%) 3 0/30 (0%) 0
    Pain in extremity 5/68 (7.4%) 12 5/32 (15.6%) 10 2/30 (6.7%) 8
    Nervous system disorders
    Dizziness 5/68 (7.4%) 23 5/32 (15.6%) 8 3/30 (10%) 17
    Dysgeusia 7/68 (10.3%) 58 7/32 (21.9%) 46 6/30 (20%) 29
    Headache 7/68 (10.3%) 28 4/32 (12.5%) 26 1/30 (3.3%) 7
    Lethargy 1/68 (1.5%) 3 2/32 (6.3%) 2 0/30 (0%) 0
    Neuropathy peripheral 6/68 (8.8%) 73 2/32 (6.3%) 14 1/30 (3.3%) 24
    Peripheral sensory neuropathy 3/68 (4.4%) 19 2/32 (6.3%) 21 3/30 (10%) 34
    Psychiatric disorders
    Anxiety 0/68 (0%) 0 2/32 (6.3%) 12 3/30 (10%) 9
    Confusional state 0/68 (0%) 0 3/32 (9.4%) 7 0/30 (0%) 0
    Depression 1/68 (1.5%) 6 0/32 (0%) 0 2/30 (6.7%) 9
    Insomnia 7/68 (10.3%) 46 3/32 (9.4%) 19 1/30 (3.3%) 1
    Reproductive system and breast disorders
    Erectile dysfunction 0/68 (0%) 0 2/22 (9.1%) 672 1/21 (4.8%) 192
    Respiratory, thoracic and mediastinal disorders
    Cough 8/68 (11.8%) 25 7/32 (21.9%) 36 5/30 (16.7%) 31
    Dyspnoea 11/68 (16.2%) 63 8/32 (25%) 16 5/30 (16.7%) 15
    Dyspnoea exertional 5/68 (7.4%) 28 0/32 (0%) 0 0/30 (0%) 0
    Epistaxis 7/68 (10.3%) 38 3/32 (9.4%) 39 1/30 (3.3%) 1
    Hiccups 0/68 (0%) 0 3/32 (9.4%) 21 0/30 (0%) 0
    Oropharyngeal pain 4/68 (5.9%) 6 1/32 (3.1%) 1 1/30 (3.3%) 1
    Pleural effusion 3/68 (4.4%) 7 2/32 (6.3%) 3 2/30 (6.7%) 11
    Skin and subcutaneous tissue disorders
    Alopecia 7/68 (10.3%) 56 3/32 (9.4%) 16 1/30 (3.3%) 9
    Dermatitis acneiform 4/68 (5.9%) 8 3/32 (9.4%) 29 3/30 (10%) 9
    Dry skin 4/68 (5.9%) 32 3/32 (9.4%) 23 1/30 (3.3%) 2
    Erythema 2/68 (2.9%) 8 0/32 (0%) 0 2/30 (6.7%) 2
    Pruritus 1/68 (1.5%) 3 1/32 (3.1%) 2 5/30 (16.7%) 32
    Rash 15/68 (22.1%) 47 4/32 (12.5%) 10 6/30 (20%) 49
    Vitiligo 0/68 (0%) 0 0/32 (0%) 0 2/30 (6.7%) 9
    Vascular disorders
    Hypotension 1/68 (1.5%) 1 2/32 (6.3%) 2 1/30 (3.3%) 1
    Phlebitis 2/68 (2.9%) 2 2/32 (6.3%) 4 2/30 (6.7%) 16

    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:
    NCT00383292
    Other Study ID Numbers:
    • 10409
    • H8K-MC-JZAF
    First Posted:
    Oct 3, 2006
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    May 1, 2018