Solid Tumor
Conditions
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.
Interventions
DRUGGDC-0919
Supplied in 50 mg and 200 mg capsules. To be taken every 12 hours with water by mouth on an empty stomach (no food or drink other than water for 2 hours prior to dose). Taken twice daily for 21 days each cycle, followed by 7 days off; or taken twice daily on 28 consecutive days of a 28-day cycle
Sponsors
Genentech, Inc.
Study design
Allocation
NA
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) | 21 days |
Countries
United States
Outcome results
None listed