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 October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01685892
First received: September 12, 2012
Last updated: October 6, 2014
Last verified: October 2014

September 12, 2012
October 6, 2014
November 2012
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01685892 on ClinicalTrials.gov Archive Site
Pharmacokinetics: Area under the concentration time curve [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of GDC-0199 (ABT-199) in Combination With Obinutuzumab in Patients With Chronic Lymphocytic Leukemia
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 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
  • Drug: GDC-0199 (ABT-199)
    Multiple doses of GDC-0199 (ABT-199)
  • Drug: Obinutuzumab
    Multiple doses of obinutuzumab
Experimental: GDC-0199 (ABT-199) Arm
Interventions:
  • Drug: GDC-0199 (ABT-199)
  • Drug: Obinutuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
November 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: GP28331 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   United Kingdom
 
NCT01685892
GP28331, 2012-002038-34
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP