NCT02048709

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

A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	GDC-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

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-01-29
• Last updated: 2017-02-06

Locations

1 site across 1 country: United States