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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02048709
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : February 6, 2017
Information provided by (Responsible Party):
Genentech, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02048709

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United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT02048709    
Other Study ID Numbers: GO29753
NLG9191 ( Other Identifier: )
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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