An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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, liver and renal function
Exclusion Criteria:
- History of prior significant toxicity from a same class of agents as GDC-0575 or
gemcitabine requiring discontinuation of treatment
- All acute toxicities related to prior therapy must have 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
- History of significant cardiac dysfunction
- History of malabsorption or other condition that would interfere with enteral
absorption
- Known HIV infection
- Pregnancy, lactation or breastfeeding
- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms
- Current use of alpha-adrenegic receptor blockers
- For Combination Arm only:
- Any contraindication to gemcitabine therapy
- 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