CompletedPhase 1NCT00974584

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 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.

Checked against the public recordLast updated Nov 2, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations3
SponsorGenentech, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Genentech, Inc.
Interventions being studied
Drug: GDC-0941; Drug: bevacizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationBuffalo, New York
  • Study locationVillejuif
  • Study locationGroningen

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2016. Always confirm current availability with the study team.

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