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 Cance

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed

Criteria

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