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
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