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

NCT02048709 | Completed Phase 1

• 2 other identifiers: GO29753NLG9191
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pharmacokinetics: Serum concentrations (Cmax/Steady State)

  21 days

Study Arms (1)

GDC-0919 Dose Escalation

EXPERIMENTAL

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

Interventions

GDC-0919 DRUG

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

GDC-0919 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Some prior cancer immunotherapies
• Untreated brain metastases
• Active or history of autoimmune disease

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• 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.

  PMID: 29921320 DERIVED

MeSH Terms

Interventions

navoximod

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 29, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

US (1)