Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: GDC-0919

• 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

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Study Start: 2014-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

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