Trial record 11 of 15 for:    GDC-0941

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 study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01493843
First received: December 14, 2011
Last updated: September 15, 2014
Last verified: September 2014

December 14, 2011
September 15, 2014
January 2012
July 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01493843 on ClinicalTrials.gov Archive Site
  • Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival (OS), defined as the time from randomization until death from any cause [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival (OS), defined as the time from randomization until death from any cause [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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 evalua te the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/ bevacizumab with and without GDC-0941 in patients with previously untreated adva nced or recurrent non-small cell lung cancer (NSCLC). Patients will be randomize d to receive 4 cycles of carboplatin/paclitaxel and either GDC-0941 or placebo, with (patients with non-squamous NSCLC) or without (patients with squamous NSCLC

) bevacizumab. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Patients in placebo arms with disease progressio n may cross over to open-label active GDC-0941.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: GDC-0941
    Repeating oral dose
  • Drug: carboplatin
    Intravenous repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: Placebo
    Repeating oral dose
  • Experimental: A
    GDC-0941 + carboplatin + paclitaxel
    Interventions:
    • Drug: GDC-0941
    • Drug: carboplatin
    • Drug: paclitaxel
  • Active Comparator: B
    Placebo + carboplatin + paclitaxel
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Placebo
  • Experimental: C/E
    GDC-0941 + carboplatin + paclitaxel + bevacizumab
    Interventions:
    • Drug: GDC-0941
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: bevacizumab
  • Active Comparator: D/F
    Placebo + carboplatin + paclitaxel + bevacizumab
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: bevacizumab
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2016
July 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
  • ECOG performance status of 0 or 1
  • Disease that is measurable per RECIST v1.1
  • Adequate hematologic and end organ function
  • Use of effective contraception

Exclusion Criteria:

  • NSCLC with documented EGFR mutation associated with response to EGFR inhibitors or documented fusion gene involving 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 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 patient at high risk for treatment complications
  • Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC
Both
18 Years and older
No
Contact: Reference Study ID Number: GO27912 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Argentina,   Australia,   Brazil,   Canada,   Chile,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Russian Federation,   Spain,   Ukraine,   United Kingdom
 
NCT01493843
GO27912
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

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