Clinical Trial Results:
Randomized phase II trial of bevacizumab (AVASTIN®) in combination with gemcitabine or attenuated doses of cisplatin and gemcitabine as
first-line treatment of elderly patients with advanced, metastatic nonsquamous non-small cell lung cancer
Summary
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EudraCT number |
2008-008739-27 |
Trial protocol |
IT |
Global end of trial date |
02 Jul 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jun 2016
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First version publication date |
10 Jun 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ML21868
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01077713 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Apr 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jul 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effects of bevacizumab + gemcitabine combination and bevacizumab + cisplatin + gemcitabine combination in elderly participants with non-squamous NSCLC by using progression-free rate (PFR) at 6 months as primary endpoint.
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Protection of trial subjects |
The study was conducted under the provisions of the Declaration of Helsinki, and in accordance with the International Conference on Harmonization (ICH) Consolidated Guideline on Good Clinical Practice (GCP).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Feb 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 86
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Worldwide total number of subjects |
86
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EEA total number of subjects |
86
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
86
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Overall, 86 participants were enrolled and all of them were randomised. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bevacizumab + Gemcitabine | ||||||||||||||||||||||||||||||
Arm description |
Participants received bevacizumab 7.5 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg on IV infusion Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Bevacizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bevacizumab (7.5 mg/kg) was administered as an IV infusion initially over a 90-minute period. If the first infusion was well tolerated, then the second infusion could be delivered over a 60-minute period. If the 60-minute infusion was well tolerated, all subsequent infusions could be delivered over a 30-minute period.
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Investigational medicinal product name |
Gemcitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Gemcitabine (1200 mg/m^2) was administered over a 30-minute IV infusion.
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Arm title
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Bevacizumab + Gemcitabine + Cisplatin | ||||||||||||||||||||||||||||||
Arm description |
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Bevacizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bevacizumab (7 mg/kg) was administered as an IV infusion initially over a 90-minute period. If the first infusion was well tolerated, then the second infusion could be delivered over a 60-minute period. If the 60-minute infusion was well tolerated, all subsequent infusions could be delivered over a 30-minute period.
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Investigational medicinal product name |
Gemcitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Gemcitabine (1200 mg/m^2) was administered over a 30-minute iv infusion.
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Investigational medicinal product name |
Cisplatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Cisplatin 60 (mg/m^2) was administered over a 1-hour IV infusion.
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Baseline characteristics reporting groups
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Reporting group title |
Bevacizumab + Gemcitabine
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Reporting group description |
Participants received bevacizumab 7.5 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg on IV infusion Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bevacizumab + Gemcitabine + Cisplatin
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Reporting group description |
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bevacizumab + Gemcitabine
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Reporting group description |
Participants received bevacizumab 7.5 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg on IV infusion Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. | ||
Reporting group title |
Bevacizumab + Gemcitabine + Cisplatin
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Reporting group description |
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity. |
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End point title |
Percentage of participants alive and without progressive disease at Month 6 [1] | ||||||||||||
End point description |
Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. All participants randomized set (RND) included all participants who provided informed consent and who were randomized to study medication. Intent-to-treat (ITT) set included all participants who provided informed consent and who were randomized to study medication who received at least one dose of any study medication; participants were classified according to treatment received.
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End point type |
Primary
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End point timeframe |
Month 6
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As this endpoint is descriptive in nature, no statistical analysis was performed. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants with Disease Progression or Death | ||||||||||||
End point description |
Disease progression was assessed according to RECIST criteria version 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 15 of Cycles 3 and 6, and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)
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No statistical analyses for this end point |
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End point title |
Progression Free Survival (PFS) | ||||||||||||
End point description |
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria version 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 15 of Cycles 3 and 6, and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
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No statistical analyses for this end point |
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End point title |
Percentage of Participants Alive at 12 Months After Randomization | ||||||||||||
End point description |
Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
From randomization to one year
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No statistical analyses for this end point |
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End point title |
Percentage of Participants who Died | ||||||||||||
End point description |
Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
From randomization to death or end of the study (up to 53 months)
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No statistical analyses for this end point |
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End point title |
Overall Survival (OS) | ||||||||||||
End point description |
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
From randomization to death or end of the study (up to 53 months)
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No statistical analyses for this end point |
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End point title |
Percentage of Participants by Best Overall Response | |||||||||||||||||||||||||||
End point description |
Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria version 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesion; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 15 of Cycles 3 and 6, and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
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No statistical analyses for this end point |
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End point title |
Percentage of Participants with an Objective Response | |||||||||||||||||||||
End point description |
Objective response was defined as having a CR or PR according to a RECIST criteria version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesion. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With Disease Control | |||||||||||||||||||||
End point description |
CR/PR/SD was measured by RECIST criteria version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesion. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Analysis was performed on ITT set.
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End point type |
Secondary
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End point timeframe |
Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
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No statistical analyses for this end point |
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End point title |
Duration of Response (DoR) | ||||||||||||
End point description |
DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from 1st documentation of a response to the date of 1st occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesion. Disease progression as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method. Here "99999" represents data not available as tt was not possible to estimate statistic using Kaplan-Meier because upper bound of 95% confidence interval was not reached. Analysis was done on ITT set.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 15 of Cycles 3 and 6, and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From baseline to 28 days after last dose of any study drug (up to 54 months)
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Adverse event reporting additional description |
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
Bevacizumab + Gemcitabine
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Reporting group description |
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg on IV infusion Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bevacizumab + Gemcitabine + Cisplatin
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Reporting group description |
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1-8 of each 21-day cycle for maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Nov 2010 |
The name of the sponsor Medical manager was changed; the exclusion criterion on radiotherapy was better clarified; specifications of end of treatment/study and of target population were better defined; the study schedule of assessments and the plan for follow-up were modified to meet the protocol definitions of adverse events reporting, and of clinical assessments and procedures; clarifications were given for the efficacy assessments; rules for the post-study provisional care were given; procedures for safety reporting and for reporting of adverse events of special interest were updated; the definition of the PP population for analysis was amended; procedures for central review of magnetic resonance imaging/computed tomography scan and for the data safety monitoring board were updated; procedures for publication of data have been updated; references for tumor assessment were updated in line with the adopted RECIST version 1.1 criteria. |
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27 Sep 2013 |
The name of the sponsor Medical manager was changed again; the definition for end of study was updated; the possibility of participation in the long-term extension study was offered to participants still on treatment with bevacizumab at end of study; the planned time for recruitment was
extended; furthers specifications for the procedures of reporting of serious adverse events were added; the list of adverse events of special interest (and their definitions) was extended; clarifications for the efficacy and safety analysis were added; details on ethics and general study
administration were added; the published reference for the ECOG performance status was added. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |