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

Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204345
• Other study ID #: BP29360
• Secondary ID: 2014-001498-15
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 24, 2014
• Last updated: January 24, 2017
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Carboplatin
Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.
• Paclitaxel
Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
• RO5479599
RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Canada,  Denmark,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events		Baseline up to Day 342
Primary	Percentage of Participants With Objective Response as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)		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	Progression-free Survival (PFS) as Assessed Using RECIST v1.1		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	Overall survival (OS)		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	Percentage of Participants With Disease Control as Assessed by Investigator Using RECIST v1.1		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	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RO5479599		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
Secondary	Maximum Observed Plasma Concentration (Cmax) of RO5479599		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
Secondary	Trough Concentration (Ctrough) of RO5479599		Pre-dose (Hour 0) on Day 1 of each cycle (cycle length = 21 days) up to EOT (Day 314)
Secondary	Total Clearance (CL) of RO5479599		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
Secondary	Volume of Distribution at Steady State (Vss) of RO5479599		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
Secondary	Accumulation Ratio (Rac) of RO5479599		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
Secondary	Terminal Elimination Half-life (t 1/2) of RO5479599		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
Secondary	Concentration of RO5479599 at the Time of Tumor Progression (Cprog)		At tumor progression (any time between Baseline and Day 342)
Secondary	Concentration of RO5479599 at the Time of Tumor Response (Complete Response or Partial Response)		At the time of tumor response (anytime between baseline and Day 342)
Secondary	Concentration of RO5479599 at the Time of Toxicity		At the time of toxicity (anytime between baseline and Day 342)
Secondary	Concentration of RO5479599 at the Time of Infusion-related Reactions (IRRs) or Hypersensitivity Reaction		At the time of IRRs or Hypersensitivity Reaction (anytime between baseline and Day 342)