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A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00481091
First received: May 30, 2007
Last updated: April 19, 2013
Last verified: April 2013
History of Changes

May 30, 2007
April 19, 2013
July 2007
September 2014   (final data collection date for primary outcome measure)
Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 14 days on therapy and 7 days off therapy OR 21 days continuous dosing ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity determination
  • Safety assessment [ Time Frame: One year ]
  • Maximum tolerated dose determination
  • Pharmacokinetic profile evaluation
Complete list of historical versions of study NCT00481091 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile evaluation [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ] [ Designated as safety issue: No ]
  • Preliminary efficacy assessment (Phase 2a) [ Time Frame: Repeating cycles of 21 days continuous dosing ] [ Designated as safety issue: No ]
  • Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ] [ Designated as safety issue: Yes ]
  • Extended safety assessment at the recommended Phase 2 dose [ Time Frame: One year ]
  • Preliminary efficacy assessment [ Time Frame: Every two months ]
Not Provided
Not Provided
 
A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to three years after the last subject transitions with less frequent study evaluations.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: ABT-263

Phase 1 dosing under two different schedules: 14 days on drug, 7 days or (14/21) or continuous dosing.

Phase 2a dosing at the recommended phase 2a dose and schedule
Experimental: Arm NA, Group is Applicable
Group/Cohort Number or Label is numerical and sequential starting with dose level 1
Intervention: Drug: ABT-263
Younes A, Romaguera J, Fanale M, McLaughlin P, Hagemeister F, Copeland A, Neelapu S, Kwak L, Shah J, de Castro Faria S, Hart S, Wood J, Jayaraman R, Ethirajulu K, Zhu J. Phase I study of a novel oral Janus kinase 2 inhibitor, SB1518, in patients with relapsed lymphoma: evidence of clinical and biologic activity in multiple lymphoma subtypes. J Clin Oncol. 2012 Nov 20;30(33):4161-7. doi: 10.1200/JCO.2012.42.5223. Epub 2012 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator
  • Eastern Cooperative Oncology Group (ECOG) <= 1
  • Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria

Exclusion Criteria:

  • History or clinically suspicious for cancer-related Central Nervous System disease
  • Receipt of allogenic or autologous stem cell transplant
  • Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding
  • Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis
  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Germany,   United Kingdom
 
NCT00481091
M06-873, 2007-002143-25
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Genentech
Study Director: Sari Enschede, MD AbbVie
AbbVie
April 2013

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