A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00974584
First received: September 8, 2009
Last updated: August 1, 2016
Last verified: August 2016

September 8, 2009
August 1, 2016
October 2009
March 2015   (final data collection date for primary outcome measure)
  • Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Days 1 to 22 of Cycle 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 5.5 years ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ]
Complete list of historical versions of study NCT00974584 on ClinicalTrials.gov Archive Site
  • Maximum Plasma Concentration of Paclitaxel [ Time Frame: Cycle 1 Day 2: Pre-paclitaxel infusion, end of paclitaxel infusion, 0.5, 1 and 2 hours post-paclitaxel infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-paclitaxel Day 2 infusion ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of Carboplatin [ Time Frame: Cycle 1 Day 2: Pre-carboplatin infusion, end of Carboplatin infusion, 0.5, 1.5 hours post-carboplatin infusion\n\n ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of Pemetrexed [ Time Frame: Cycle 1 Day 2: Pre-pemetrexed infusion, end of pemetrexed infusion, 1, 3 hours post-pemetrexed infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-pemetrexed Day 2 infusion\n\nd be "Yes". ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of Cisplatin [ Time Frame: Cycle 1 Day 2: Pre-cisplatin infusion, end of cisplatin infusion, 3 hours post-cisplatin infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-pemetrexed Day 2 infusion\n\n ] [ Designated as safety issue: No ]
  • Percentage of Participants with Objective Response (Complete or Partial Response), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years)\n\n ] [ Designated as safety issue: No ]
  • Duration of Response, as Assessed Using RECIST\n\n\n [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years) ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS), as Assessed Using RECIST\n [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years)\n\n ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration of GDC-0941 [ Time Frame: Cycle 1 Days 1 and 2: Pre-GDC-0941 dose, 1, 2, 3 and 4 hours post-GDC-0941 dose; Cycle 1 Days 3 and 9: Pre-GDC-0941 dose; 30 days after last dose of study treatment (up to approximately 5.5 years) ] [ Designated as safety issue: No ]
PK parameters of GDC-0941, paclitaxel, and carboplatin (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ]
Not Provided
Not Provided
 
A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: GDC-0941
    The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n
  • Drug: bevacizumab
    Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.
  • Drug: carboplatin
    Carboplation IV on Day 1 of every 3-week cycle, at a dose to achieve an area under concentration time curve of 6 milligrams per milliliter*minute (mg/mL*min).\n
  • Drug: cisplatin
    Cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of every 3-week cycle.\n
  • Drug: paclitaxel
    Paclitaxel 200 mg/m^2 IV on Day 1 of every 3-week cycle.\n\n
  • Drug: pemetrexed
    Pemetrexed 500 mg/m^2 IV on Day 1 of every 3-week cycle.
  • Experimental: GDC-0941+Paclitaxel+Carboplatin
    Bevacizumab-ineligible non-small cell lung cancer (NSCLC) participants may receive up to 6 cycles (21-day cycle) of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941
    Interventions:
    • Drug: GDC-0941
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: GDC-0941+Paclitaxel+Carboplatin+Bevacizumab
    Bevacizumab-eligible NSCLC particpants may receive up to 6 cycles of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941 and bevacizumab.
    Interventions:
    • Drug: GDC-0941
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: GDC-0941+Pemetrexed+Cisplatin
    Bevacizumab-ineligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941.\n
    Interventions:
    • Drug: GDC-0941
    • Drug: bevacizumab
    • Drug: cisplatin
    • Drug: pemetrexed
  • Experimental: GDC-0941+Pemetrexed+Cisplatin+Bevacizumab
    Bevacizumab-eligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941 and bevacizumab.\n
    Interventions:
    • Drug: GDC-0941
    • Drug: bevacizumab
    • Drug: cisplatin
    • Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented NSCLC with advanced disease (Stage IIIb not eligible for chemoradiotherapy or Stage IV or recurrent disease)
  • Adequate organ function as assessed by laboratory tests
  • Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

  • More than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced NSCLC prior to initiation of study treatment
  • Any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
  • History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
  • Active autoimmune disease, active infection requiring IV antibiotics, or other current uncontrolled illness
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease
  • Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
  • Known brain metastases that are untreated, symptomatic, or require therapy
  • Pregnancy, lactation, or breastfeeding
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Netherlands
 
NCT00974584
GDC4628g, GO01303
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
August 2016

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