Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
- Registration Number
- NCT02048709
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists
- Age > or = 18
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Life expectancy > or = 12 weeks
- Adequate hematologic and organ function before initiation of GDC-0919
- For some patients only: Accessible lesions amenable to paired fresh tumor biopsies
Exclusion Criteria
- Some prior cancer immunotherapies
- Untreated brain metastases
- Active or history of autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GDC-0919 Dose Escalation GDC-0919 GDC-0919 to be given on an outpatient basis as a single agent. Starting dose of GDC-0919 will be 50 mg by mouth every 12 hour. Patients will receive the study drug daily for 21 days followed by 7 days off for a cycle length of 28 days; or on 28 consecutive days of a 28-day cycle
- Primary Outcome Measures
Name Time Method Percentage of patients with dose-limiting toxicities 28 days Number of dose-limiting toxicities 28 days Percentage of patients with adverse events approximately 15 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Serum concentrations (Cmax/Steady State) 21 days
Trial Locations
- Locations (1)
Georgia Regents University
🇺🇸Augusta, Georgia, United States