A Study of GDC-0199 (ABT-199) in Combination With Obinutuzumab in Patients With Chronic Lymphocytic Leukemia
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/8/2015 |
| Start Date: | November 2012 |
| End Date: | November 2016 |
| Contact: | Reference Study ID Number: GP28331 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
A Phase Ib Multicenter Dose-Finding And Safety Study Of GDC-0199 And Obinutuzumab in Patients With Relapsed Or Refractory Or Previously Untreated Chronic Lymphocytic Leukemia
This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics of GDC-0199 (ABT-199) administered in combination with obinutuzumab to
patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. The
anticipated time on study treatment is 6 months.
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pharmacokinetics of GDC-0199 (ABT-199) administered in combination with obinutuzumab to
patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. The
anticipated time on study treatment is 6 months.
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Inclusion Criteria:
- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic
leukemia
- Eastern Cooperative Oncology Group (ECOG) performance score of >/=1
- Adequate bone marrow function
- Adequate renal and hepatic function
Exclusion Criteria:
- Patient received an allogeneic stem cell transplant
- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Investigational or anti-cancer therapy within 14 days of study start
- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease
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