Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2016 |
| Start Date: | April 2014 |
| End Date: | November 2016 |
| Contact: | Reference Study ID Number: GO29753 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. and Canada) |
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.
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.
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
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