Clinical Trial Results:
Open-Label Phase Ib/II, Multicenter Study of the Combination of RO5479599 With Carboplatin and Paclitaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) of Squamous Histology who Have not Received Prior Chemotherapy or Targeted Therapy for NSCLC
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Summary
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EudraCT number |
2014-001498-15 |
Trial protocol |
DK ES NL GB |
Global end of trial date |
14 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Nov 2016
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First version publication date |
24 Nov 2016
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Other versions |
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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 |
BP29360
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02204345 | ||
WHO universal trial number (UTN) |
- | ||
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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 Ltd., 41 61 6878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F.Hoffmann-La Roche Ltd., 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 |
14 Mar 2016
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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 |
14 Mar 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
This was an open-label, single -arm, multicenter, Phase Ib/II study to evaluate the safety, tolerability, and efficacy (as measured by the objective response rate [ORR]) of RO5479599 in combination with carboplatin and paclitaxel.
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Protection of trial subjects |
This study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever affords the greater protection to the individual. The study complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Oct 2014
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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 |
Canada: 1
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Country: Number of subjects enrolled |
Spain: 10
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Country: Number of subjects enrolled |
Denmark: 1
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Worldwide total number of subjects |
12
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EEA total number of subjects |
11
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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) |
4
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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Screening details |
Twelve participants were enrolled in the safety run-in phase and received treatment with RO5479599 in combination with carboplatin and paclitaxel. | ||||||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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RO5479599+Carboplatin+Paclitaxel | ||||||||||||||||
Arm description |
RO5479599 800 milligrams (mg) was administered in the Safety Run-In Phase by intravenous infusion once every 3 weeks (q3w) on Day 1 of 3-weekly cycles (each cycle of 21 days) in combination with carboplatin (to produce an area under the curve [AUC] of 6 mg/milliliter [mL]*minute) and paclitaxel 200 mg per square meter (mg/m^2) by intravenous infusion q3w for 4 to 6 cycles. Thereafter, RO5479599 was continued as a monotherapy (carboplatin and paclitaxel could be continued at the investigator’s discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
RO5479599
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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 |
RO5479599 was administered as an IV infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent
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Investigational medicinal product name |
Carboplatin
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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 |
Carboplatin by intravenous infusion q3w for 4 to 6 cycles and thereafter as per investigator's discretion.
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Investigational medicinal product name |
Paclitaxel
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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 |
Paclitaxel by intravenous infusion q3w for 4 to 6 cycles and thereafter as per investigator's discretion.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
RO5479599 800 mg was administered in the Safety Run-In Phase by intravenous infusion q3w on Day 1 of 3-weekly cycles (each cycle of 21 days) in combination with carboplatin (to produce an AUC of 6 mg/mL*minute and paclitaxel 200 mg/m^2 by intravenous infusion q3w for 4 to 6 cycles. Thereafter, RO5479599 was continued as a monotherapy (carboplatin and paclitaxel could be continued at the investigator’s discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
RO5479599+Carboplatin+Paclitaxel
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Reporting group description |
RO5479599 800 milligrams (mg) was administered in the Safety Run-In Phase by intravenous infusion once every 3 weeks (q3w) on Day 1 of 3-weekly cycles (each cycle of 21 days) in combination with carboplatin (to produce an area under the curve [AUC] of 6 mg/milliliter [mL]*minute) and paclitaxel 200 mg per square meter (mg/m^2) by intravenous infusion q3w for 4 to 6 cycles. Thereafter, RO5479599 was continued as a monotherapy (carboplatin and paclitaxel could be continued at the investigator’s discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | ||
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End point title |
Percentage of Participants With Objective Response as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [1] | ||||||||
End point description |
Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 4 weeks apart. Participants were evaluated for tumor response for target lesions and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal (>=) 30% decrease from baseline in the sum of diameters of target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions; Efficacy analysis population: all participants enrolled in the study who received at least 1 dose of study treatment in the safety run-in phase.
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End point type |
Primary
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End point timeframe |
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
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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: The study was of an explorative nature; therefore only descriptive and exploratory statistical methods were applied, and no statistical hypothesis testing was carried out. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With Disease Progression as Assessed Using RECIST v1.1 | ||||||||
End point description |
Disease Progression (PD): at least 20% increase in the sum of diameters of target lesions compared to the 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. Efficacy analysis population.
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End point type |
Secondary
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End point timeframe |
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression-free Survival (PFS) as Assessed Using RECIST v1.1 | ||||||||
End point description |
PFS is defined as the time from the first dose of study treatment to disease progression or death, whichever occurs first. Participants who do not progress or die while being followed were censored on the date of the last valid tumor assessment. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, that is, PFS was assigned a value of 1 day and was censored in the analysis. PD: at least 20% increase in the sum of diameters of target lesions compared to the 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. Efficacy analysis population.
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End point type |
Secondary
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End point timeframe |
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
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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 is defined as the time from the first dose of study medication to death. Participants who do not die while being followed up were censored on the date of last contact. OS was estimated using Kaplan-Meier method. Efficacy analysis population. Median and corresponding 95% confidence interval (CI) could not be estimated due to higher number (>50%) of censored participants and have been reported as 99999.
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End point type |
Secondary
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End point timeframe |
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With Disease Control as Assessed by Investigator Using RECIST v1.1 | ||||||||
End point description |
Disease control was defined as having a best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1. CR: complete disappearance of all target lesions and non-target disease (except nodal disease). All nodes, must decrease to normal (short axis<10 mm). No new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. 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. PD: at least 20% increase in the sum of diameters of target lesions compared to the 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. Efficacy analysis population.
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End point type |
Secondary
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End point timeframe |
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RO5479599 | ||||||||
End point description |
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [2] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum Observed Plasma Concentration (Cmax) of RO5479599 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [3] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Trough Concentration (Ctrough) of RO5479599 | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) on Day 1 of each cycle (cycle length = 21 days) up to EOT (Day 314)
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| Notes [4] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Total clearance (CL) of RO5479599 | ||||||||
End point description |
Clearence was estimated as dose divided by the area under plasma concentration-time curve from time zero to infinity where the dose is the of amount RO5479599 actually administered.
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [5] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Volume of Distribution at Steady State (Vss) of RO5479599 | ||||||||
End point description |
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [6] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Accumulation Ratio (Rac) of RO5479599 | ||||||||
End point description |
Rac was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC, Day 342) from time 0-t divided by AUC from time 0-t (Day 1).
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [7] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Terminal Elimination Half-life (t 1/2) of RO5479599 | ||||||||
End point description |
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
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End point type |
Secondary
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End point timeframe |
Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length = 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4;at Day 342
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| Notes [8] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Concentration of RO5479599 at the Time of Tumor Progression (Cprog) | ||||||||
End point description |
PD: at least 20% increase in the sum of diameters of target lesions compared to the 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.
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End point type |
Secondary
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End point timeframe |
At tumor progression (any time between Baseline and Day 342)
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| Notes [9] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Concentration of RO5479599 at the Time of Tumor Response (CR or PR) | ||||||||
End point description |
CR: complete disappearance of all target lesions and non-target disease (except nodal disease). All nodes, must decrease to normal(short axis <10 mm). No new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
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End point type |
Secondary
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End point timeframe |
At the time of tumor response (anytime between baseline and Day 342)
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| Notes [10] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Concentration of RO5479599 at the Time of Toxicity | ||||||||
End point description |
The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.3 was used to grade toxicity. NCI-CTCAE: Grade 1: mild; asymptomatic or mild symptoms, clinical or diagnostic observations only, or intervention not indicated; Grade 2: moderate; minimal, local, or non-invasive intervention indicated or limiting age-appropriate instrumental activities of daily living; Grade 3: severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated; Grade 5: Death related to toxicity.
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End point type |
Secondary
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End point timeframe |
At the time of toxicity (anytime between baseline and Day 342)
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| Notes [11] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Concentration of RO5479599 at the Time of Infusion-related Reactions (IRRs) or Hypersensitivity Reaction | ||||||||
End point description |
IRR was monitored until complete resolution of the symptoms and treated as clinically indicated.
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End point type |
Secondary
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End point timeframe |
At the time of IRRs or Hypersensitivity Reaction (anytime between baseline and Day 342)
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| Notes [12] - No data is reported since the PK data was not analyzed due to early termination of the study. |
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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 |
Safety analysis population included all participants who have received at least 1 dose of the study treatment, whether prematurely withdrawn from the study or not.
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End point type |
Secondary
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End point timeframe |
Baseline up to Day 342
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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 |
Baseline up to Day 342
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Adverse event reporting additional description |
Safety analysis population.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
RO5479599+Carboplatin+Paclitaxel
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Reporting group description |
RO5479599 800 mg was administered in the Safety Run-In Phase by intravenous infusion q3w on Day 1 of 3-weekly cycles (each cycle of 21 days) in combination with carboplatin (to produce an AUC of 6 mg/mL*minute and paclitaxel 200 mg/m^2 by intravenous infusion q3w for 4 to 6 cycles. Thereafter, RO5479599 was continued as a monotherapy (carboplatin and paclitaxel could be continued at the investigator’s discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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19 Sep 2014 |
Inclusion criteria related to tumor biopsies and contraceptive methods was clarified. |
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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. | |||
| The study was prematurely terminated due to a strategic decision taken by the Sponsor to stop further development of RO5479599. | |||
