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A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
This study is currently recruiting participants.
Verified by Abbott, December 2008
Sponsors and Collaborators: Abbott
Genentech
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00406809
  Purpose

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

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 14/21 day dosing schedule (Phase 1a) [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: No ]
  • Determination of ABT-263 dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a continuous dosing schedule (Phase 1b) [ Time Frame: Continuous dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off OR continuous dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile evaluation [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off OR continuous dosing ] [ Designated as safety issue: No ]
  • Effect of food on bioavailability [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: No ]
  • Preliminary efficacy assessment (Phase 2a) [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off OR continuous dosing ] [ Designated as safety issue: No ]

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

Detailed Description:

Enrollment breakdown: Phase 1a: 40; Phase 1b: 10; Phase 2a: 60 Total: 110

  Eligibility

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

Inclusion Criteria:

  • >= 18 years of age.
  • Documented diagnoses:

    • 1a/1b - lymphoid malignancy/WHO;
    • 2a, Arm A - follicular lymphoma;
    • 2a, Arm B - mantle cell, peripheral or cutaneous T-cell, or B-cell lymphomas;
    • 2a, Arm C - diffuse large B-cell lymphoma. Received at least 1 prior chemotherapy treatment regimen (P1a/1b) & have relapsed or refractory disease.
  • ECOG score of <= 1.
  • Age of >= 70 documented MRI or CT negative for subdural or epidural hematoma w/i 28 days prior to 1st dose.
  • Receiving a stable dose of SSRI antidepressants for at least 21 days prior to 1st dose.
  • Adequate bone marrow (BM) function, renal & hepatic function as follows:

    • ANC >= 1000/µL;
    • Platelets >= 100,000/mm3;
    • Hemoglobin >= 9.0/dL;
    • Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50;
    • AST and ALT <= 3.0 x ULN;
    • Bilirubin <= 1.5 x ULN.
    • Gilbert's Syndrome may have a bilirubin > 1.5 x ULN; aPTT, PT not to exceed 1.2 x ULN.
  • Females must be surgically sterile, postmenopausal (at least 1 year), or negative results for a pregnancy test performed at Screening on a serum sample obtained w/i 14 days prior to initial dose, & prior to dosing on a urine sample obtained on C1 D-3 (P1a) or Lead-in D1 (P1b), or C1D1 (P2a) if > 7 days since serum results.
  • Females not surgically sterile or postmenopausal (at least 1 year) & non-vasectomized males must practice birth control.
  • P2a only: History of autologous BM transplant must be > 6 months post transplant with adequate BM function, renal and hepatic function as follows:

    • ANC >= 1500/µL;
    • Platelets >= 125,000/mm3;
    • Hemoglobin >= 10.0g/dL;
    • Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50;
    • AST and ALT <= 3.0 x ULN;
    • Bilirubin <= 1.5 x ULN.
    • Gilbert's Syndrome may have bilirubin > 1.5 x ULN; aPTT, PT not to exceed 1.2 x ULN.
  • Measurable disease by IWG criteria for tumor response.
  • Archived diagnostic tissue for assessment of Bcl-2 family protein expression. One of following for PD:

    • core needle biopsy of malignant lymph node,
    • bone marrow aspirate or core positive for lymphoma, or
    • archived tumor tissue with no intervening treatment since biopsy.

Exclusion Criteria:

  • History of, or is, clinically suspicious for cancer-related CNS disease, lymphoid or non-lymphoid.
  • Undergone an allogeneic or autologous stem cell transplant.
  • Underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 1 year prior to 1st dose.
  • Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 year prior to 1st dose.
  • Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
  • Females pregnant or breast-feeding.
  • Positive for HIV.
  • Previous or current malignancies at other sites, except adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma; previous malignancy confined and surgically resected with no evidence of disease w/i 3 years.
  • Evidence of other clinically significant uncontrolled condition(s), including, but not limited to active systemic fungal infection; diagnosis of fever and neutropenia w/i 1 week prior to study drug.
  • Received steroid therapy w/i 7 days prior to 1st dose of study drug for anti-neoplastic intent.
  • Received any anti-cancer therapy, including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy, w/i 14 days prior to 1st dose of study drug, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy.
  • Received a biologic w/i 30 days prior to 1st dose.
  • Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications that are used to maintain the patency of a central venous catheter.
  • Received aspirin w/i 7 days prior to 1st dose and during ABT-263 administration.
  • Consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose.
  • P1a/1b only: Diagnosed with PTLD; Burkitt's, Burkitt-like, or HIV-associate lymphoma; lymphoblastic lymphoma/leukemia; or multiple myeloma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406809

Contacts
Contact: Lori A Gressick, BS 847-936-1579 lori.gressick@abbott.com

Locations
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    
Sponsors and Collaborators
Abbott
Genentech
Investigators
Study Director: Global Medical Information Abbott (1-800-633-9110) Abbott
  More Information

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

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009