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OpenTrials
Completed

NCT Number: NCT02048709

Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgia Regents University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of patients with dose-limiting toxicities

    Time frame: 28 days

  2. Number of dose-limiting toxicities

    Time frame: 28 days

  3. Percentage of patients with adverse events

    Time frame: approximately 15 months

Secondary outcomes

  1. Pharmacokinetics: Serum concentrations (Cmax/Steady State)

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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