A Study of GDC-0199 (ABT-199) in Combination With Obinutuzumab in Patients With Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01685892
First received: September 12, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multi-center, open-label, dose-finding study will evaluate the safety and p harmacokinetics of GDC-0199 (ABT-199) administered in combination with obinutuzu mab to patients with relapsed/refractory or previously untreated chronic lymphoc ytic leukemia. The anticipated time on study treatment is 6 months.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: GDC-0199 (ABT-199)
Drug: Obinutuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration time curve [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDC-0199 (ABT-199) Arm Drug: GDC-0199 (ABT-199)
Multiple doses of GDC-0199 (ABT-199)
Drug: Obinutuzumab
Multiple doses of obinutuzumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01685892

Contacts
Contact: Reference Study ID Number: GP28331 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
La Jolla, California, United States, 92093
United States, Colorado
Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Terminated
Sarasota, Florida, United States, 34232
United States, New York
Recruiting
Buffalo, New York, United States, 14263
Recruiting
New York, New York, United States, 10065
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Completed
Springfield, Oregon, United States, 97477
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Houston, Texas, United States, 77030
United States, West Virginia
Terminated
Morgantown, West Virginia, United States, 26506
United Kingdom
Recruiting
Leeds, United Kingdom, LS9 7TF
Recruiting
Leicester, United Kingdom, LE1 5WW
Recruiting
London, United Kingdom, E1 2AD
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01685892     History of Changes
Other Study ID Numbers: GP28331, 2012-002038-34
Study First Received: September 12, 2012
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Obinutuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014