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3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01563354
Collaborator
(none)
124
Enrollment
36
Locations
3
Arms
77.8
Actual Duration (Months)
3.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus

Condition or Disease Intervention/Treatment Phase
  • Drug: Pasireotide LAR
  • Drug: Everolimus
  • Drug: Pasireotide LAR and Everolimus Combination
 Phase 2

Detailed Description

This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study was to test the effectiveness and safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. It was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. Patients were seen weekly for one month and monthly thereafter. Radiological and biochemical response assessments were performed every 3 months.

Patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide LAR and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. Patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. All patients had a safety follow-up visit 56 days after last treatment dose.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma of the Lung and Thymus - LUNA Trial
Actual Study Start Date :
Aug 16, 2013
Actual Primary Completion Date :
Feb 10, 2020
Actual Study Completion Date :
Feb 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pasireotide LAR

Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1

Drug: Pasireotide LAR
60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1
Other Names:
  • SOM230

    		•
    Experimental: Everolimus

    Everolimus 10 mg taken orally (p.o) once daily starting on Day 1

    Drug: Everolimus
    10 mg tables administered orally once a day
    Other Names:
  • RAD001

    		•
    Experimental: Pasireotide LAR and Everolimus Combination

    Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1

    Drug: Pasireotide LAR and Everolimus Combination
    Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
    Other Names:
  • SOM230 + RAD001

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) [Baseline up to 9 months]

      Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".

    Secondary Outcome Measures

    1. Summary of Progression-free Survival (PFS) Based on RECIST v1.1 [Baseline, every 3 months up to 69 months]

      Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

    2. Kaplan-Meier Estimates of Progression-free Survival (PFS) [Baseline, every 3 months up to 69 months]

      Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.

    3. Summary of Time to Response (Months) [Every 3 months up to Year 1]

      Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.

    4. Summary of Duration of Response (Months) [Every 3 months up to Year 1]

      Date of first objective tumor response to date of tumor progression or death due to any cause.

    5. 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) [Baseline up to Month 12]

      Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.

    6. Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels [Baseline up to Week 52]

      Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.

    7. Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) [Baseline up to Month 18]

      Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

    8. Kaplan-Meier Event-free Probability Estimate Based on CgA Levels [Baseline, every 3 months up to Month 18]

      Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.

    9. Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment [Baseline up Month 24]

      Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

    10. Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels [Baseline, every 3 months up to Month 24]

      Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels >= 25% compared to baseline or deaths due to any cause.

    11. Biochemical Response Rate (BRR) for 5HIAA Levels [Baseline up Week 52]

      The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of >= 50% from baseline of 5HIAA concentrations.

    Eligibility Criteria

    Criteria

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

    • Histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus

    • Patients of all treatment lines including naive patients could have been enrolled

    • At least one measurable lesion of disease on CT scan or MRI

    • Radiological documentation of disease progression within 12 months prior to randomization

    • Adequate liver, renal and bone marrow function

    • WHO Performance Status 0-2

    Exclusion Criteria:

    • Poorly differentiated neuroendocrine carcinoma

    • Non-neuroendocrine thymoma

    • Patients with severe functional disease who required symptomatic treatment with somatostatin analogs

    • Prior therapy with mTOR inhibitors

    • History of liver disease

    • Baseline QTcF> 470 msec

    • Uncontrolled diabetes mellitus despite adequate therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Aarhus Denmark 8000 C
    2 Novartis Investigative Site Copenhagen N Denmark DK-2200
    3 Novartis Investigative Site Toulouse Cedex 9 France 31000
    4 Novartis Investigative Site Creteil France 94000
    5 Novartis Investigative Site Lille Cedex France 59037
    6 Novartis Investigative Site Lyon France 69437
    7 Novartis Investigative Site Rennes France 35043
    8 Novartis Investigative Site Strasbourg Cedex France 67091
    9 Novartis Investigative Site Villejuif Cedex France 94800
    10 Novartis Investigative Site Bad Berka Germany 99438
    11 Novartis Investigative Site Berlin Germany 13125
    12 Novartis Investigative Site Mainz Germany 55131
    13 Novartis Investigative Site Athens GR Greece 115 27
    14 Novartis Investigative Site Ancona AN Italy 60126
    15 Novartis Investigative Site Brescia BS Italy 25123
    16 Novartis Investigative Site Viagrande CT Italy 95029
    17 Novartis Investigative Site Milano MI Italy 20141
    18 Novartis Investigative Site Padova PD Italy 35100
    19 Novartis Investigative Site Perugia PG Italy 06129
    20 Novartis Investigative Site Parma PR Italy 43100
    21 Novartis Investigative Site Roma RM Italy 00128
    22 Novartis Investigative Site Orbassano TO Italy 10043
    23 Novartis Investigative Site Napoli Italy 80131
    24 Novartis Investigative Site Amsterdam Netherlands 1066 CX
    25 Novartis Investigative Site Groningen Netherlands 9713 GZ
    26 Novartis Investigative Site Granada Andalucia Spain 18014
    27 Novartis Investigative Site Sevilla Andalucia Spain 41013
    28 Novartis Investigative Site Oviedo Asturias Spain 33006
    29 Novartis Investigative Site Valencia Comunidad Valenciana Spain 46014
    30 Novartis Investigative Site Barcelona Spain 08041
    31 Novartis Investigative Site Madrid Spain 28046
    32 Novartis Investigative Site Lund Sweden 221 85
    33 Novartis Investigative Site Withington Greater Manchester United Kingdom M20 4BX
    34 Novartis Investigative Site Glasgow United Kingdom G12 0YN
    35 Novartis Investigative Site London United Kingdom NW3 2QG
    36 Novartis Investigative Site London United Kingdom SE1 9RT

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01563354
    Other Study ID Numbers:
    • CSOM230DIC03
    • 2011-002872-17
    First Posted:
    Mar 27, 2012
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Novartis Pharmaceuticals
    neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Neuroendocrine
    Lung Neoplasms
    Everolimus
    Pasireotide
    Somatostatin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Two patients completed the core phase of the study but they did not enter the extension phase one due to worsening in clinical conditions and one for Physician decision.
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Period Title: Core Phase
    STARTED 41 42 41
    Entered Extension Phase 12 14 15
    COMPLETED 12 14 15
    NOT COMPLETED 29 28 26
    Period Title: Core Phase
    STARTED 12 14 15
    COMPLETED 0 0 0
    NOT COMPLETED 12 14 15

    Baseline Characteristics

    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination Total
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1 Total of all reporting groups
    Overall Participants 41 42 41 124
    Age, Customized (participants) [Number]
    18 to <65
    21
    51.2%
    18
    42.9%
    24
    58.5%
    63
    50.8%
    ≥65 to 84
    20
    48.8%
    24
    57.1%
    17
    41.5%
    61
    49.2%
    Sex: Female, Male (Count of Participants)
    Female
    15
    36.6%
    19
    45.2%
    13
    31.7%
    47
    37.9%
    Male
    26
    63.4%
    23
    54.8%
    28
    68.3%
    77
    62.1%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    40
    97.6%
    42
    100%
    40
    97.6%
    122
    98.4%
    Black
    1
    2.4%
    0
    0%
    0
    0%
    1
    0.8%
    Asian
    0
    0%
    0
    0%
    1
    2.4%
    1
    0.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
    Description Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
    Time Frame Baseline up to 9 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    Complete response
    0
    0%
    0
    0%
    0
    0%
    Partial response
    2.4
    5.9%
    2.4
    5.7%
    2.4
    5.9%
    Stable disease
    34.1
    83.2%
    31.0
    73.8%
    48.8
    119%
    Progression-free (PF) at Month 9
    39.0
    95.1%
    33.3
    79.3%
    58.5
    142.7%
    2. Secondary Outcome
    Title Summary of Progression-free Survival (PFS) Based on RECIST v1.1
    Description Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
    Time Frame Baseline, every 3 months up to 69 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    Median (95% Confidence Interval) [months]
    8.51
    12.48
    16.53
    3. Secondary Outcome
    Title Kaplan-Meier Estimates of Progression-free Survival (PFS)
    Description Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.
    Time Frame Baseline, every 3 months up to 69 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    3 months
    83.6
    91.2
    88.6
    6 months
    68.2
    63.5
    85.5
    9 months
    49.6
    56.9
    79.2
    12 months
    39.9
    50.2
    55.5
    15 months
    32.6
    46.8
    51.2
    18 months
    21.8
    38.6
    42.7
    21 months
    14.5
    29.4
    38.0
    24 months
    14.5
    19.6
    28.5
    27 months
    14.5
    19.6
    28.5
    30 months
    10.9
    9.8
    19.0
    33 months
    10.9
    9.8
    19.0
    36 months
    10.9
    9.8
    14.2
    39 months
    10.9
    9.8
    14.2
    42 months
    10.9
    9.8
    14.2
    45 months
    10.9
    9.8
    14.2
    48 months
    10.9
    9.8
    14.2
    51 months
    10.9
    NA
    14.2
    54 months
    10.9
    NA
    14.2
    57 months
    10.9
    NA
    7.1
    60 months
    10.9
    NA
    7.1
    63 months
    10.9
    NA
    7.1
    66 months
    NA
    NA
    7.1
    69 months
    NA
    NA
    7.1
    4. Secondary Outcome
    Title Summary of Time to Response (Months)
    Description Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.
    Time Frame Every 3 months up to Year 1

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    25th percentile
    NA
    NA
    NA
    Median
    NA
    NA
    NA
    75th percentile
    NA
    NA
    NA
    5. Secondary Outcome
    Title Summary of Duration of Response (Months)
    Description Date of first objective tumor response to date of tumor progression or death due to any cause.
    Time Frame Every 3 months up to Year 1

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    25th percentile
    NA
    NA
    NA
    Median
    NA
    NA
    NA
    75th percentile
    NA
    NA
    NA
    6. Secondary Outcome
    Title 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
    Description Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.
    Time Frame Baseline up to Month 12

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    Objective response (CR+PR)
    2.4
    5.9%
    2.4
    5.7%
    4.9
    12%
    Disease control rate (CR+PR+SD)
    80.5
    196.3%
    73.8
    175.7%
    78.0
    190.2%
    Complete response (CR)
    0
    0%
    0
    0%
    0
    0%
    Partial response (PR)
    2.4
    5.9%
    2.4
    5.7%
    4.9
    12%
    Stable disease
    78.0
    190.2%
    71.4
    170%
    73.2
    178.5%
    Progressive disease
    14.6
    35.6%
    4.8
    11.4%
    7.3
    17.8%
    Unknown
    2.4
    5.9%
    4.8
    11.4%
    0
    0%
    Not assessed
    2.4
    5.9%
    16.7
    39.8%
    14.6
    35.6%
    Discontinued before month 12
    68.3
    166.6%
    64.3
    153.1%
    63.4
    154.6%
    7. Secondary Outcome
    Title Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
    Description Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.
    Time Frame Baseline up to Week 52

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants with CgA levels outside normal range at baseline.
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 34 27 35
    Week 12
    20.6
    50.2%
    7.4
    17.6%
    17.1
    41.7%
    Week 24
    8.8
    21.5%
    7.4
    17.6%
    20.0
    48.8%
    Week 36
    8.8
    21.5%
    3.7
    8.8%
    11.4
    27.8%
    Week 48
    8.8
    21.5%
    0
    0%
    11.4
    27.8%
    Week 52
    5.9
    14.4%
    0
    0%
    5.7
    13.9%
    8. Secondary Outcome
    Title Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)
    Description Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
    Time Frame Baseline up to Month 18

    Outcome Measure Data

    Analysis Population Description
    Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 8 4 9
    Median (95% Confidence Interval) [months]
    14.75
    2.00
    8.38
    9. Secondary Outcome
    Title Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
    Description Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.
    Time Frame Baseline, every 3 months up to Month 18

    Outcome Measure Data

    Analysis Population Description
    Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 8 4 9
    3 months
    75.0
    37.5
    77.8
    6 months
    56.3
    NA
    77.8
    9 months
    56.3
    NA
    44.4
    12 months
    56.3
    NA
    44.4
    15 months
    37.5
    NA
    44.4
    18 months
    37.5
    NA
    44.4
    10. Secondary Outcome
    Title Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment
    Description Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
    Time Frame Baseline up Month 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    Median (95% Confidence Interval) [months]
    2.89
    2.86
    5.62
    11. Secondary Outcome
    Title Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
    Description Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels >= 25% compared to baseline or deaths due to any cause.
    Time Frame Baseline, every 3 months up to Month 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 41 42 41
    3 months
    43.1
    35.4
    77.1
    6 months
    29.5
    17.7
    44.5
    9 months
    18.5
    11.0
    29.7
    12 months
    18.5
    7.4
    26.4
    15 months
    18.5
    NA
    18.1
    18 months
    13.8
    NA
    18.1
    21 months
    13.8
    NA
    18.1
    24 months
    NA
    NA
    18.1
    12. Secondary Outcome
    Title Biochemical Response Rate (BRR) for 5HIAA Levels
    Description The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of >= 50% from baseline of 5HIAA concentrations.
    Time Frame Baseline up Week 52

    Outcome Measure Data

    Analysis Population Description
    Full analysis set - participants with 5HIAA levels within normal range at baseline are excluded from the table, therefore 'n' stands for the number of patients with 5-HIAA levels outside normal range at baseline.
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1 Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
    Measure Participants 20 18 20
    Week 12
    20.0
    48.8%
    11.1
    26.4%
    10.0
    24.4%
    Week 24
    5.0
    12.2%
    11.1
    26.4%
    20.0
    48.8%
    Week 36
    5.0
    12.2%
    11.1
    26.4%
    5.0
    12.2%
    Week 48
    5.0
    12.2%
    0
    0%
    5.0
    12.2%
    Week 52
    5.0
    12.2%
    0
    0%
    10.0
    24.4%

    Adverse Events

    Time Frame Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
    Adverse Event Reporting Description
    Arm/Group Title Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Arm/Group Description Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    All Cause Mortality
    Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/41 (4.9%) 7/42 (16.7%) 3/41 (7.3%)
    Serious Adverse Events
    Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/41 (41.5%) 20/42 (47.6%) 16/41 (39%)
    Blood and lymphatic system disorders
    Anaemia 0/41 (0%) 1/42 (2.4%) 1/41 (2.4%)
    Cardiac disorders
    Atrial flutter 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Cardiac failure 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Tachycardia paroxysmal 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Endocrine disorders
    Carcinoid crisis 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Carcinoid syndrome 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Cushing's syndrome 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/41 (0%) 2/42 (4.8%) 0/41 (0%)
    Abdominal pain upper 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Ascites 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Constipation 2/41 (4.9%) 0/42 (0%) 0/41 (0%)
    Diarrhoea 1/41 (2.4%) 3/42 (7.1%) 2/41 (4.9%)
    Dysphagia 0/41 (0%) 2/42 (4.8%) 0/41 (0%)
    Ileus 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Intestinal obstruction 1/41 (2.4%) 0/42 (0%) 1/41 (2.4%)
    Nausea 0/41 (0%) 2/42 (4.8%) 0/41 (0%)
    Salivary gland pain 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Stomatitis 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Vomiting 1/41 (2.4%) 1/42 (2.4%) 1/41 (2.4%)
    General disorders
    Asthenia 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Axillary pain 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Chest pain 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Disease progression 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Face oedema 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    General physical health deterioration 3/41 (7.3%) 2/42 (4.8%) 0/41 (0%)
    Multiple organ dysfunction syndrome 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Non-cardiac chest pain 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Oedema peripheral 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Pyrexia 1/41 (2.4%) 3/42 (7.1%) 1/41 (2.4%)
    Hepatobiliary disorders
    Cholecystocholangitis 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Hepatic failure 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Jaundice 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Infections and infestations
    Aspergillus infection 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Febrile infection 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Gastroenteritis 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Lower respiratory tract infection 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Oesophageal candidiasis 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Pneumonia 5/41 (12.2%) 2/42 (4.8%) 0/41 (0%)
    Sepsis 1/41 (2.4%) 1/42 (2.4%) 0/41 (0%)
    Urinary tract infection 2/41 (4.9%) 1/42 (2.4%) 0/41 (0%)
    Urosepsis 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Injury, poisoning and procedural complications
    Contusion 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Haematuria traumatic 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Radiation oesophagitis 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Investigations
    Blood creatinine increased 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    C-reactive protein increased 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Liver function test increased 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Weight decreased 0/41 (0%) 2/42 (4.8%) 0/41 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Diabetes mellitus 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Hyperammonaemia 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Hypercalcaemia 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Hyperglycaemia 0/41 (0%) 1/42 (2.4%) 1/41 (2.4%)
    Hyperkalaemia 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Hyponatraemia 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Metabolic acidosis 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Nervous system disorders
    Altered state of consciousness 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Brain compression 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Headache 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Loss of consciousness 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Spinal cord compression 2/41 (4.9%) 0/42 (0%) 0/41 (0%)
    Syncope 2/41 (4.9%) 0/42 (0%) 0/41 (0%)
    Psychiatric disorders
    Confusional state 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Delirium 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Depression 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Renal and urinary disorders
    Acute kidney injury 0/41 (0%) 2/42 (4.8%) 1/41 (2.4%)
    Anuria 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Dysuria 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Bronchospasm 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Cough 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Dyspnoea 3/41 (7.3%) 3/42 (7.1%) 1/41 (2.4%)
    Hydrothorax 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Lung disorder 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Pleural effusion 3/41 (7.3%) 1/42 (2.4%) 0/41 (0%)
    Pneumonia aspiration 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Pneumonitis 0/41 (0%) 2/42 (4.8%) 2/41 (4.9%)
    Pulmonary embolism 1/41 (2.4%) 2/42 (4.8%) 1/41 (2.4%)
    Respiratory distress 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Respiratory failure 0/41 (0%) 1/42 (2.4%) 1/41 (2.4%)
    Skin and subcutaneous tissue disorders
    Angioedema 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Rash 0/41 (0%) 1/42 (2.4%) 0/41 (0%)
    Skin haemorrhage 1/41 (2.4%) 0/42 (0%) 0/41 (0%)
    Vascular disorders
    Deep vein thrombosis 0/41 (0%) 0/42 (0%) 1/41 (2.4%)
    Hypotension 2/41 (4.9%) 0/42 (0%) 0/41 (0%)
    Other (Not Including Serious) Adverse Events
    Pasireotide LAR Everolimus Pasireotide LAR and Everolimus Combination
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/41 (97.6%) 42/42 (100%) 40/41 (97.6%)
    Blood and lymphatic system disorders
    Anaemia 9/41 (22%) 14/42 (33.3%) 10/41 (24.4%)
    Leukopenia 0/41 (0%) 3/42 (7.1%) 3/41 (7.3%)
    Thrombocytopenia 0/41 (0%) 9/42 (21.4%) 7/41 (17.1%)
    Cardiac disorders
    Palpitations 4/41 (9.8%) 1/42 (2.4%) 1/41 (2.4%)
    Ear and labyrinth disorders
    Vertigo 3/41 (7.3%) 0/42 (0%) 0/41 (0%)
    Gastrointestinal disorders
    Abdominal pain 15/41 (36.6%) 6/42 (14.3%) 6/41 (14.6%)
    Abdominal pain upper 5/41 (12.2%) 5/42 (11.9%) 3/41 (7.3%)
    Aphthous ulcer 0/41 (0%) 3/42 (7.1%) 0/41 (0%)
    Constipation 9/41 (22%) 6/42 (14.3%) 0/41 (0%)
    Diarrhoea 17/41 (41.5%) 21/42 (50%) 33/41 (80.5%)
    Dyspepsia 1/41 (2.4%) 0/42 (0%) 3/41 (7.3%)
    Dysphagia 0/41 (0%) 4/42 (9.5%) 0/41 (0%)
    Flatulence 2/41 (4.9%) 0/42 (0%) 4/41 (9.8%)
    Haemorrhoids 3/41 (7.3%) 1/42 (2.4%) 4/41 (9.8%)
    Mouth ulceration 0/41 (0%) 3/42 (7.1%) 6/41 (14.6%)
    Nausea 11/41 (26.8%) 10/42 (23.8%) 8/41 (19.5%)
    Steatorrhoea 4/41 (9.8%) 0/42 (0%) 2/41 (4.9%)
    Stomatitis 2/41 (4.9%) 26/42 (61.9%) 14/41 (34.1%)
    Toothache 2/41 (4.9%) 1/42 (2.4%) 4/41 (9.8%)
    Vomiting 5/41 (12.2%) 5/42 (11.9%) 4/41 (9.8%)
    General disorders
    Asthenia 11/41 (26.8%) 12/42 (28.6%) 16/41 (39%)
    Chills 4/41 (9.8%) 0/42 (0%) 0/41 (0%)
    Fatigue 6/41 (14.6%) 9/42 (21.4%) 16/41 (39%)
    Non-cardiac chest pain 3/41 (7.3%) 4/42 (9.5%) 3/41 (7.3%)
    Oedema peripheral 8/41 (19.5%) 13/42 (31%) 12/41 (29.3%)
    Pyrexia 7/41 (17.1%) 7/42 (16.7%) 6/41 (14.6%)
    Infections and infestations
    Bronchitis 2/41 (4.9%) 3/42 (7.1%) 1/41 (2.4%)
    Cystitis 1/41 (2.4%) 4/42 (9.5%) 0/41 (0%)
    Folliculitis 0/41 (0%) 1/42 (2.4%) 4/41 (9.8%)
    Influenza 5/41 (12.2%) 2/42 (4.8%) 2/41 (4.9%)
    Lower respiratory tract infection 0/41 (0%) 1/42 (2.4%) 4/41 (9.8%)
    Rhinitis 3/41 (7.3%) 1/42 (2.4%) 0/41 (0%)
    Urinary tract infection 4/41 (9.8%) 2/42 (4.8%) 7/41 (17.1%)
    Investigations
    Alanine aminotransferase increased 3/41 (7.3%) 3/42 (7.1%) 3/41 (7.3%)
    Aspartate aminotransferase increased 4/41 (9.8%) 3/42 (7.1%) 1/41 (2.4%)
    Blood alkaline phosphatase increased 7/41 (17.1%) 2/42 (4.8%) 2/41 (4.9%)
    Blood creatinine increased 2/41 (4.9%) 1/42 (2.4%) 3/41 (7.3%)
    Gamma-glutamyltransferase increased 10/41 (24.4%) 4/42 (9.5%) 4/41 (9.8%)
    Glycosylated haemoglobin increased 3/41 (7.3%) 1/42 (2.4%) 3/41 (7.3%)
    Platelet count decreased 0/41 (0%) 1/42 (2.4%) 3/41 (7.3%)
    Weight decreased 18/41 (43.9%) 18/42 (42.9%) 24/41 (58.5%)
    Metabolism and nutrition disorders
    Decreased appetite 10/41 (24.4%) 16/42 (38.1%) 13/41 (31.7%)
    Diabetes mellitus 9/41 (22%) 4/42 (9.5%) 8/41 (19.5%)
    Hypercholesterolaemia 1/41 (2.4%) 7/42 (16.7%) 5/41 (12.2%)
    Hyperglycaemia 18/41 (43.9%) 14/42 (33.3%) 36/41 (87.8%)
    Hypertriglyceridaemia 3/41 (7.3%) 9/42 (21.4%) 5/41 (12.2%)
    Hypoglycaemia 2/41 (4.9%) 2/42 (4.8%) 3/41 (7.3%)
    Hypokalaemia 2/41 (4.9%) 3/42 (7.1%) 5/41 (12.2%)
    Hypomagnesaemia 4/41 (9.8%) 2/42 (4.8%) 3/41 (7.3%)
    Hyponatraemia 2/41 (4.9%) 0/42 (0%) 3/41 (7.3%)
    Hypophosphataemia 1/41 (2.4%) 3/42 (7.1%) 5/41 (12.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/41 (7.3%) 1/42 (2.4%) 3/41 (7.3%)
    Back pain 10/41 (24.4%) 6/42 (14.3%) 7/41 (17.1%)
    Bone pain 2/41 (4.9%) 2/42 (4.8%) 3/41 (7.3%)
    Joint swelling 2/41 (4.9%) 1/42 (2.4%) 3/41 (7.3%)
    Muscle spasms 5/41 (12.2%) 2/42 (4.8%) 1/41 (2.4%)
    Musculoskeletal chest pain 4/41 (9.8%) 2/42 (4.8%) 2/41 (4.9%)
    Musculoskeletal pain 4/41 (9.8%) 1/42 (2.4%) 2/41 (4.9%)
    Neck pain 3/41 (7.3%) 1/42 (2.4%) 0/41 (0%)
    Pain in extremity 3/41 (7.3%) 1/42 (2.4%) 4/41 (9.8%)
    Nervous system disorders
    Dizziness 6/41 (14.6%) 2/42 (4.8%) 2/41 (4.9%)
    Dysgeusia 4/41 (9.8%) 5/42 (11.9%) 4/41 (9.8%)
    Headache 7/41 (17.1%) 4/42 (9.5%) 6/41 (14.6%)
    Presyncope 3/41 (7.3%) 0/42 (0%) 0/41 (0%)
    Taste disorder 0/41 (0%) 0/42 (0%) 3/41 (7.3%)
    Psychiatric disorders
    Insomnia 2/41 (4.9%) 4/42 (9.5%) 3/41 (7.3%)
    Renal and urinary disorders
    Dysuria 3/41 (7.3%) 2/42 (4.8%) 1/41 (2.4%)
    Polyuria 1/41 (2.4%) 0/42 (0%) 3/41 (7.3%)
    Renal failure 2/41 (4.9%) 4/42 (9.5%) 0/41 (0%)
    Urinary incontinence 0/41 (0%) 0/42 (0%) 3/41 (7.3%)
    Reproductive system and breast disorders
    Erectile dysfunction 0/41 (0%) 0/42 (0%) 3/41 (7.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 9/41 (22%) 12/42 (28.6%) 14/41 (34.1%)
    Dyspnoea 8/41 (19.5%) 11/42 (26.2%) 6/41 (14.6%)
    Epistaxis 0/41 (0%) 5/42 (11.9%) 3/41 (7.3%)
    Haemoptysis 0/41 (0%) 1/42 (2.4%) 3/41 (7.3%)
    Pneumonitis 0/41 (0%) 2/42 (4.8%) 4/41 (9.8%)
    Productive cough 0/41 (0%) 2/42 (4.8%) 7/41 (17.1%)
    Skin and subcutaneous tissue disorders
    Dry skin 0/41 (0%) 3/42 (7.1%) 4/41 (9.8%)
    Onychoclasis 0/41 (0%) 3/42 (7.1%) 3/41 (7.3%)
    Palmar-plantar erythrodysaesthesia syndrome 0/41 (0%) 3/42 (7.1%) 2/41 (4.9%)
    Pruritus 2/41 (4.9%) 2/42 (4.8%) 7/41 (17.1%)
    Rash 3/41 (7.3%) 12/42 (28.6%) 6/41 (14.6%)
    Vascular disorders
    Flushing 1/41 (2.4%) 2/42 (4.8%) 4/41 (9.8%)
    Hypertension 2/41 (4.9%) 2/42 (4.8%) 3/41 (7.3%)
    Hypotension 3/41 (7.3%) 2/42 (4.8%) 1/41 (2.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

    Results Point of Contact

    Name/Title Study Director
    Organization Novartis Pharmaceuticals
    Phone + 1 862 778 8300
    Email Novartis.email@Novartis.com
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01563354
    Other Study ID Numbers:
    • CSOM230DIC03
    • 2011-002872-17
    First Posted:
    Mar 27, 2012
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021