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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Genentech, Inc.
Study ID
NCT00974584
Phase
PHASE1
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDC-0941 — DRUG
    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
  • bevacizumab — DRUG
    Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.
  • carboplatin — DRUG
    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
  • cisplatin — DRUG
    Cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of every 3-week cycle.\\n
  • paclitaxel — DRUG
    Paclitaxel 200 mg/m\^2 IV on Day 1 of every 3-week cycle.\\n\\n
  • pemetrexed — DRUG
    Pemetrexed 500 mg/m\^2 IV on Day 1 of every 3-week cycle.

Study Details

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.

Key Dates

First listed
Sep 10, 2009
Start date
Oct 31, 2009
Status verified
Nov 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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.
  • 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
  • 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

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Days 1 to 22 of Cycle 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-BuffaloNew York14263-

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