A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
• •History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
• •History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
• •Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
• •History of glaucoma
• •Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
• •Current severe, uncontrolled systemic disease
• •History of clinically significant cardiac dysfunction
• •History of active gastrointestinal bleeding within 6 months prior to screening
• •Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
• •Active autoimmune disease
• •Uncontrolled ascites
• •Pregnancy, lactation, or breastfeeding
• •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
• •For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts