Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Abbott Genentech |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00406809 |
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Lymphoma, Follicular |
Drug: ABT-263 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies |
Estimated Enrollment: | 110 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A,B,C Phase 2 Only: Experimental
For Phase 2 only, Patients with indolent lymphoma, aggressive lymphoma, and CLL
|
Drug: ABT-263
oral solution, repeating sequence of 14 days on therapy and 7 days off OR continuous dosing until disease progression
|
Enrollment breakdown: Phase 1a: 40; Phase 1b: 10; Phase 2a: 60 Total: 110
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented diagnoses:
Adequate bone marrow (BM) function, renal & hepatic function as follows:
P2a only: History of autologous BM transplant must be > 6 months post transplant with adequate BM function, renal and hepatic function as follows:
Archived diagnostic tissue for assessment of Bcl-2 family protein expression. One of following for PD:
Exclusion Criteria:
Contact: Lori A Gressick, BS | 847-936-1579 | lori.gressick@abbott.com |
United States, California | |
University of Southern California- Norris Cancer Center | Recruiting |
Los Angeles, California, United States | |
Contact: Nancy Berman, RN, BSN 323-865-3928 berman_n@ccnt.usc.edu | |
City of Hope Medical Center | Not yet recruiting |
Duarte, California, United States | |
Contact: Deron Matsuoka 626-256-4673 ext 65043 dmatsuoka@coh.org | |
United States, Maryland | |
National Cancer Institute | Recruiting |
Bethesda, Maryland, United States | |
Contact: Peggy Shovlin, RN, BSN, OCN 301-594-6597 MShovlin@mail.nih.gov | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States | |
Contact: Sarah Scofield 617-582-8713 sarah.scofield@dfci.harvard.edu | |
Principal Investigator: Ann LaCasce, MD | |
United States, New York | |
Memorial Sloan Kettering | Recruiting |
New York, New York, United States | |
Contact: Payal Dixit 646-227-2190 dixitp@mskcc.org | |
Columbia University | Recruiting |
New York, New York, United States | |
Contact: Ameet Narwal 212-342-3513 an2284@columbia.edu | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States | |
Contact: Barbara Anderson 716-845-1573 barbara.anderson@roswellpark.org | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States | |
Contact: Sandy Markus 212-746-1493 sam2020@med.cornell.edu |
Study Director: | Global Medical Information Abbott (1-800-633-9110) | Abbott |
Responsible Party: | Abbott ( Sari Enschede, MD ) |
Study ID Numbers: | M06-814 |
Study First Received: | November 30, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00406809 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Follicular Lymphoma, Non-Hodgkin |
Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |