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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

approximately 30 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GP28331

NCT ID:

NCT01685892

Start Date:

November 2012

Completion Date:

August 2015

Related Keywords:

  • Lymphocytic Leukemia, Chronic
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Chronic Disease

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Eugene, Oregon  
Charleston, West Virginia  25304