Status:
COMPLETED
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lymphom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01226277
Start Date
October 1 2010
End Date
September 1 2012
Last Update
November 2 2016
Active Locations (2)
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1
Nashville, Tennessee, United States, 37203
2
San Antonio, Texas, United States, 98229