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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02048709
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: GDC-0919	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GDC-0919 Dose Escalation 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	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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with dose-limiting toxicities [28 days]

2. Number of dose-limiting toxicities [28 days]

3. Percentage of patients with adverse events [approximately 15 months]

Secondary Outcome Measures

1. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Regents University	Augusta	Georgia	United States	30912

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT02048709
• Other Study ID Numbers: GO29753; NLG9191
• First Posted: Jan 29, 2014
• Last Update Posted: Feb 6, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 6, 2017