Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01493843
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE December 14, 2011
First Posted Date  ICMJE December 16, 2011
Last Update Posted Date April 25, 2017
Actual Study Start Date  ICMJE January 20, 2012
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Progression-free Survival (PFS) [ Time Frame: Up to approximately 2.5 years ]
  • PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification [ Time Frame: Up to approximately 2.5 years ]
  • PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low [ Time Frame: Up to approximately 2.5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
Progression-free survival (PFS), defined as the time from randomization to disease progression as assessed by the\investigator per RECIST v1.1 [ Time Frame: up to approximately 26 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Objective Tumor Response [ Time Frame: Up to approximately 2.5 years ]
  • Objective Tumor Response in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • Objective Tumor Response in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Duration of Objective Response (DoR) [ Time Frame: Up to approximately 2.5 years ]
  • DoR in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • DoR in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 2.5 years ]
  • OS in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • OS in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ]
  • Duration of objective response, defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the\investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ]
  • Overall survival (OS), defined as the time from randomization until death from any cause [ Time Frame: up to approximately 26 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Official Title  ICMJE A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Brief Summary This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pictilisib
    Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
    Other Name: GDC-0941
  • Drug: Placebo
    Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
  • Drug: bevacizumab
    Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
    Other Name: Avastin
  • Drug: carboplatin
    Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
  • Drug: paclitaxel
    Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Study Arms  ICMJE
  • Experimental: Arm A: 340 mg pictilisib + CP
    Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).
    Interventions:
    • Drug: pictilisib
    • Drug: carboplatin
    • Drug: paclitaxel
  • Placebo Comparator: Arm B: Placebo + CP
    Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm A during the first 4 cycles with carboplatin + paclitaxel or after chemotherapy has been completed (Cycle >/= 5).
    Interventions:
    • Drug: Placebo
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Arm C: 340 mg pictilisib + CPB
    Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
    Interventions:
    • Drug: pictilisib
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Placebo Comparator: Arm D: Placebo + CPB
    Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm C during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).
    Interventions:
    • Drug: Placebo
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Arm E: 260 mg pictilisib + CPB
    Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
    Interventions:
    • Drug: pictilisib
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Placebo Comparator: Arm F: Placebo + CPB
    Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm E during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).
    Interventions:
    • Drug: Placebo
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2016)
501
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2011)
302
Actual Study Completion Date  ICMJE March 30, 2016
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)
  • Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Adequate hematologic and end organ function
  • Use of two effective forms of contraception

Exclusion Criteria:

  • NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (ALK) gene
  • Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day 1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC
  • Known central nervous system (CNS) disease except for treated brain metastases
  • Type I diabetes
  • Type II diabetes requiring chronic therapy with insulin
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications
  • Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01493843
Other Study ID Numbers  ICMJE GO27912
2011-002893-21 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP