An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

Inclusion Criteria:

- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

- Signed Informed Consent Form

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

- Adequate hematologic and end-organ (liver and kidney) function

- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement by the patient that the patient and/or partner will
use an effective form of contraception

- Patients enrolled in certain phases must be willing to provide fresh and/or archival
tumor samples

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