A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Documented locally advanced or metastatic solid tumors for which standard therapy
either does not exist or has proven ineffective or intolerable (dose-escalation stage
only)

- Documented locally advanced or metastatic NSCLC in patients who have failed at least
one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage
only)

- Adequate organ function as assessed by laboratory tests

- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid
Tumors (RECIST)

- Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

- Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy)
within a specified timeframe prior to first study treatment

- Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)

- History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication

- Current clinically significant and uncontrolled systemic disease (e.g.,
cardiovascular, pulmonary, or metabolic)

- 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

- Active autoimmune disease and/or need for corticosteroid therapy

- Known brain metastases that are untreated, symptomatic, or require therapy

- Pregnancy, lactation, or breastfeeding