Solid Cancers
Conditions
Brief summary
This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.
Interventions
DRUGGDC-0917
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in vital signs, ECGs, and clinical laboratory results | Throughout study or until early discontinuation |
| Incidence and nature of dose-limiting toxicities and adverse events of special interest | Throughout study or until early discontinuation |
| Incidence, nature, and severity of all adverse events and serious adverse events | Throughout study or until early discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state) | Throughout study or until early discontinuation |
Countries
United States
Outcome results
None listed