A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

- Histologically or cytologically documented, locally advanced or metastatic solid
tumors for which standard therapy either does not exist or has proven ineffective or
intolerable

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

- Life expectancy >= 12 weeks

- Adequate hematologic and end organ function

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

Exclusion Criteria:

- History of prior significant toxicity from another MEK pathway inhibitor requiring
discontinuation of treatment

- History of prior significant toxicity from another PI3K pathway inhibitor requiring
discontinuation of treatment

- Allergy or hypersensitivity to components of the GDC-0973 or GDC-0941 formulations

- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in
Cycle 1

- Experimental therapy within 4 weeks prior to first dose of study drug treatment in
Cycle 1

- Major surgical procedure or significant traumatic injury within 4 weeks prior to
first dose of study drug treatment in Cycle 1, or anticipation of the need for major
surgery during the course of study treatment

- Prior anti-cancer therapy within 28 days before the first dose of study drug
treatment in Cycle 1

- History of diabetes requiring daily medication, or history of Grade >= 3 fasting
hyperglycemia

- Current severe, uncontrolled systemic disease

- History of clinically significant cardiac or pulmonary dysfunction

- History of malabsorption or other condition that would interfere with enteral
absorption

- Clinically significant history of liver disease (including cirrhosis), current
alcohol abuse, or current known active infection with HIV, hepatitis B virus, or
hepatitis C virus

- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics

- Active autoimmune disease

- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive
weeks prior to enrollment

- Pregnancy, lactation, or breastfeeding

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

- No other history of or ongoing malignancy that would potentially interfere with the
interpretation of the pharmacodynamic or efficacy assays