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Trial record 1 of 1 for:    NCT02048709
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Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02048709
First received: January 10, 2014
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Solid Tumor
Drug: GDC-0919
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of patients with dose-limiting toxicities [ Time Frame: 28 days ]
  • Number of dose-limiting toxicities [ Time Frame: 28 days ]
  • Percentage of patients with adverse events [ Time Frame: approximately 15 months ]

Secondary Outcome Measures:
  • Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: 21 days ]

Enrollment: 22
Study Start Date: April 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048709

Locations
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02048709     History of Changes
Other Study ID Numbers: GO29753  NLG9191 
Study First Received: January 10, 2014
Last Updated: February 2, 2017

ClinicalTrials.gov processed this record on February 20, 2017