A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Cancers

Intervention / Treatment
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* Drug: GDC-0917


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: GDC-0917<br>* Oral repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |