A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Changes in vital signs, ECGs, and clinical laboratory results [ Time Frame: Throughout study or until early discontinuation ]
Incidence and nature of dose-limiting toxicities and adverse events of special interest [ Time Frame: Throughout study or until early discontinuation ]
Incidence, nature, and severity of all adverse events and serious adverse events [ Time Frame: Throughout study or until early discontinuation ]
Secondary Outcome Measures
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) [ Time Frame: Throughout study or until early discontinuation ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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