OHSU

IRB #

IRB00010123

Title

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0853 in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Principal Investigator

Andy Chen

Study Purpose

To see what side effects, good or bad, study drug, GDC-0853, has on participants with previously treated Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. The study drug is taken daily by mouth and is part of a class of drugs called a Bruton's tyrosine kinase inhibitor.

Medical Condition(s)

Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Eligibility Criteria

- Diagnosis of Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) that has failed prior treatments
- Measurable disease by CT scan
- Laboratory results that meet study specific criteria
- Agreement to use contraception while on study
- No active infections, history of liver disease, vasculitis, pancreatitis, HIV, hepatitis, heart disease or current alcohol abuse.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Up to 2 years of treatment with study drug with a 30 day follow up period.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Genentech, Inc.

Recruitment End

12/31/2014

Compensation Provided

No


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