Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01493843
First received: December 14, 2011
Last updated: April 21, 2017
Last verified: April 2017

December 14, 2011
April 21, 2017
January 20, 2012
March 30, 2016   (Final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT01493843 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
March 30, 2016
March 30, 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Chile,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Russian Federation,   Spain,   Ukraine,   United Kingdom
 
 
NCT01493843
GO27912
2011-002893-21 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Genentech, Inc.
April 2017

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