A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors
Inclusion Criteria:
- Histologically or cytologically documented locally advanced or metastatic solid
tumors for which standard therapies either do not exist or have 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
Exclusion Criteria:
- History of prior significant toxicity from another MEK pathway inhibitor requiring
discontinuation of treatment
- History of prior significant toxicity from another PI3K or Akt pathway or mTOR
inhibitor requiring discontinuation of treatment
- Anti-cancer therapy within 28 days prior to first dose of study drug, except as
stated in protocol
- History of type I or type II diabetes mellitus requiring insulin
- Current severe, uncontrolled systemic disease (e.g. clinically significant
cardiovascular, pulmonary, or metabolic disease)
- Clinically significant history of liver disease, current alcohol abuse, or current
known active infection with HIV, hepatitis B or hepatitis C virus
- Active autoimmune disease
- Pregnant or lactating women
- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms
- History of glaucoma
- History of retinal vein occlusion