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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: GDC-0919

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Serum concentrations (Cmax/Steady State)	21 days

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• Nayak-Kapoor A, Hao Z, Sadek R, Dobbins R, Marshall L, Vahanian NN, Jay Ramsey W, Kennedy E, Mautino MR, Link CJ, Lin RS, Royer-Joo S, Liang X, Salphati L, Morrissey KM, Mahrus S, McCall B, Pirzkall A, Munn DH, Janik JE, Khleif SN. Phase Ia study of the indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor navoximod (GDC-0919) in patients with recurrent advanced solid tumors. J Immunother Cancer. 2018 Jun 20;6(1):61. doi: 10.1186/s40425-018-0351-9.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GO29753; NLG9191 (Other Identifier: clinicaltrials.gov)