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Trial record 1 of 1 for:    BP29360
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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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ClinicalTrials.gov Identifier: NCT02204345
Recruitment Status : Terminated
First Posted : July 30, 2014
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Squamous Non-Small Cell Lung Cancer Drug: Carboplatin Drug: Paclitaxel Drug: RO5479599 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: RO5479599 + Carboplatin + Paclitaxel
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.
Drug: Carboplatin
Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.

Drug: Paclitaxel
Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Drug: RO5479599
RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to Day 342 ]
  2. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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 ]
  5. 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 ]
  6. 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) ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. Concentration of RO5479599 at the Time of Tumor Progression (Cprog) [ Time Frame: At tumor progression (any time between Baseline and Day 342) ]
  12. 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) ]
  13. Concentration of RO5479599 at the Time of Toxicity [ Time Frame: At the time of toxicity (anytime between baseline and Day 342) ]
  14. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204345


Locations
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Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Denmark
København Ø, Denmark, 2100
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Madrid, Spain, 28050
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02204345    
Other Study ID Numbers: BP29360
2014-001498-15 ( EudraCT Number )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action