A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

Exclusion Criteria

• •History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment
• •Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine
• •Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment
• •Radiotherapy within 2 weeks prior to first dose of study drug treatment
• •More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
• •History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
• •History of receiving radiation to more than 25% of bone marrow-bearing areas
• •Acute drug-related toxicities from previous therapies have not resolved prior to study entry, except for alopecia and mild neuropathy
• •Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer
• •Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility
• •Uncontrolled ascites, due to diseases other than cancer
• •Inability or unwillingness to swallow pills/capsules
• •History of malabsorption or other condition that would interfere with drug absorption
• •Any history of active stomach and/or intestine bleeding within the 6 months prior to screening
• •Known HIV infection
• •Pregnancy, lactation, or breastfeeding
• •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
• •Inability to comply with study and follow up procedures