An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma
Inclusion Criteria:
- 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
- Life expectancy >/= 12 weeks
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement (by patient and/or partner) to use an effective
form of contraception and to continue its use for the duration of the study.
Exclusion Criteria:
- Clinically significant history of chronic liver disease, active hepatic infection,
evidence of hepatic cirrhosis or Grade >/= 2 liver dysfunction not due to hepatic
metastases of cancer, current alcohol abuse, active infections with hepatitis B
virus, or hepatitis C virus
- Grade >/= 2 fever or associated constitutional symptoms, or a clinically significant
systemic infection within the last month
- Autoimmune disease
- History of clinically significant pulmonary disease
- Need for chronic and continuous systemic or topical corticosteroids or
immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of
continuous systemic corticosteroids or immunosuppressive therapy during study
participation.
- Allergy or hypersensitivity to components of the GDC-0917 formulation
- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in
Cycle 1
- Experimental therapy within 4 weeks prior to first dose of study drug treatment in
Cycle 1
- Major surgical procedure or significant traumatic injury within 4 weeks prior to
first dose of study drug treatment in Cycle 1, or anticipation of the need for major
surgery during the course of study treatment
- Prior anti-cancer therapy within 4 weeks before the first dose of study drug
treatment in Cycle 1
- All acute drug-related toxicities must have resolved prior to study entry, except for
alopecia and Grade 1 neuropathy.
- Current severe, uncontrolled systemic disease excluding cancer
- History of clinically significant cardiac dysfunction
- History of malabsorption or other condition that would interfere with enteral
absorption
- Any history of active GI bleeding within the past 6 months prior to screening
- Known HIV infection
- Uncontrolled ascites, due to diseases other than cancer, requiring weekly
large-volume paracentesis for 3 consecutive weeks prior to enrollment
- Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the
study and for 3 months after the last dose of GDC-0917
- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms