Back to resultsA Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology
Primary Purpose
Squamous Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
RO5479599
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Participants with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC
- No prior systemic chemotherapy, targeted therapy for metastatic NSCLC
- Evidence of at least one radiologically measurable lesion as per RECIST version 1.1
- Adequate hematological, liver and renal function
- Participants must agree to either remain completely abstinent or to use effective contraceptive methods from screening until 6 months after the last dose of study treatment
- Histologically confirmed squamous NSCLC participants eligible for enrollment must provide archival tumor biopsy tissue or if unavailable must be willing to undergo a fresh pretreatment primary tumor or metastatic biopsy
- Participants with Gilbert's Syndrome will be eligible for the study
Exclusion Criteria:
- Concurrent therapy with any other investigational drug
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases
- Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
- Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Major surgery or significant traumatic injury less than (<) 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Pregnant or breast-feeding women
- History of other malignancies that could affect compliance with protocol or interpretation of results. Participants with malignancies diagnosed more than 5 years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RO5479599 + Carboplatin + Paclitaxel
Arm Description
RO5479599 800 milligrams (mg) will be 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 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 will be continued as a monotherapy (carboplatin and paclitaxel may be continued at the investigator's discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events
Percentage of Participants With Objective Response as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Secondary Outcome Measures
Progression-free Survival (PFS) as Assessed Using RECIST v1.1
Overall survival (OS)
Percentage of Participants With Disease Control as Assessed by Investigator Using RECIST v1.1
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RO5479599
Maximum Observed Plasma Concentration (Cmax) of RO5479599
Trough Concentration (Ctrough) of RO5479599
Total Clearance (CL) of RO5479599
Volume of Distribution at Steady State (Vss) of RO5479599
Accumulation Ratio (Rac) of RO5479599
Terminal Elimination Half-life (t 1/2) of RO5479599
Concentration of RO5479599 at the Time of Tumor Progression (Cprog)
Concentration of RO5479599 at the Time of Tumor Response (Complete Response or Partial Response)
Concentration of RO5479599 at the Time of Toxicity
Concentration of RO5479599 at the Time of Infusion-related Reactions (IRRs) or Hypersensitivity Reaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02204345
Brief Title
A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO5479599 + Carboplatin + Paclitaxel
Arm Type
Experimental
Arm Description
RO5479599 800 milligrams (mg) will be 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 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 will be continued as a monotherapy (carboplatin and paclitaxel may be continued at the investigator's discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
RO5479599
Intervention Description
RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline up to Day 342
Title
Percentage of Participants With Objective Response as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame
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)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed Using RECIST v1.1
Time Frame
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)
Title
Overall survival (OS)
Time Frame
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)
Title
Percentage of Participants With Disease Control as Assessed by Investigator Using RECIST v1.1
Time Frame
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)
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RO5479599
Time Frame
Pre-dose(Hour 0); 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
Title
Maximum Observed Plasma Concentration (Cmax) of RO5479599
Time Frame
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 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
Title
Trough Concentration (Ctrough) of RO5479599
Time Frame
Pre-dose (Hour 0) on Day 1 of each cycle (cycle length = 21 days) up to EOT (Day 314)
Title
Total Clearance (CL) of RO5479599
Time Frame
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 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
Title
Volume of Distribution at Steady State (Vss) of RO5479599
Time Frame
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 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
Title
Accumulation Ratio (Rac) of RO5479599
Time Frame
Pre-dose(Hour 0); 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
Title
Terminal Elimination Half-life (t 1/2) of RO5479599
Time Frame
Pre-dose(Hour 0); 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
Title
Concentration of RO5479599 at the Time of Tumor Progression (Cprog)
Time Frame
At tumor progression (any time between Baseline and Day 342)
Title
Concentration of RO5479599 at the Time of Tumor Response (Complete Response or Partial Response)
Time Frame
At the time of tumor response (anytime between baseline and Day 342)
Title
Concentration of RO5479599 at the Time of Toxicity
Time Frame
At the time of toxicity (anytime between baseline and Day 342)
Title
Concentration of RO5479599 at the Time of Infusion-related Reactions (IRRs) or Hypersensitivity Reaction
Time Frame
At the time of IRRs or Hypersensitivity Reaction (anytime between baseline and Day 342)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC
No prior systemic chemotherapy, targeted therapy for metastatic NSCLC
Evidence of at least one radiologically measurable lesion as per RECIST version 1.1
Adequate hematological, liver and renal function
Participants must agree to either remain completely abstinent or to use effective contraceptive methods from screening until 6 months after the last dose of study treatment
Histologically confirmed squamous NSCLC participants eligible for enrollment must provide archival tumor biopsy tissue or if unavailable must be willing to undergo a fresh pretreatment primary tumor or metastatic biopsy
Participants with Gilbert's Syndrome will be eligible for the study
Exclusion Criteria:
Concurrent therapy with any other investigational drug
History or clinical evidence of central nervous system (CNS) primary tumors or metastases
Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Major surgery or significant traumatic injury less than (<) 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
Pregnant or breast-feeding women
History of other malignancies that could affect compliance with protocol or interpretation of results. Participants with malignancies diagnosed more than 5 years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology
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