Study Assessing the Safety and Efficacy of ABT-263 in Subjects With B-cell Chronic Lymphocytic Leukemia (CLL) Who Have Failed at Least One Prior Fludarabine-containing Regimen

This study has been withdrawn prior to enrollment.
(Sponsor has decided to not proceed with this study.)
Sponsor:
Collaborator:
Genentech
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00918450
First received: May 22, 2009
Last updated: February 25, 2010
Last verified: February 2010

May 22, 2009
February 25, 2010
March 2010
December 2012   (final data collection date for primary outcome measure)
  • Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. [ Time Frame: monthly (at a minimum) ] [ Designated as safety issue: Yes ]
  • Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00918450 on ClinicalTrials.gov Archive Site
  • Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assess the effects of ABT-263 on time to response, 12-month survival rate, time to disease progression (TTP), and disease control rate in subjects with B-cell CLL . [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Investigate the effects of ABT-263 on quality of life (FACT-Leu and EQ-5D), ECOG performance status, and biomarkers in subject with B-cell CLL. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Assessing the Safety and Efficacy of ABT-263 in Subjects With B-cell Chronic Lymphocytic Leukemia (CLL) Who Have Failed at Least One Prior Fludarabine-containing Regimen
A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy of ABT-263 in subjects with B-cell CLL who have failed at least one prior fludarabine-containing regimen.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
B-cell Chronic Lymphocytic Leukemia
Drug: ABT-263

Continuous dosing until disease progression using one of the following formulations:

25 mg/mL oral solution OR 50 mg/mL oral solution OR 2.0 grams/bottle powder for oral solution of 25 mg/mL when mixed OR 2.0 grams/bottle powder for oral solution of 50 mg/mL when mixed

Other Name: ABT-263
Experimental: 1
Intervention: Drug: ABT-263
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
150
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >= 18 yrs of age, have B-cell CLL, failed at least 1 prior fludarabine-containing regimen.
  • Refractory to 1 fludarabine-containing regimen is defined as failure to achieve at least PR to the last fludarabine-containing regimen received, or disease progression while receiving the last fludarabine-containing regimen, or disease progression in responders (i.e., achieved a PR or CR) within 6 mos of the last cycle of the last fludarabine-containing regimen received (e.g., fludarabine monotherapy, FR, or FC) or in responders (i.e., achieved a PR or CR ) within 24 mos of the last cycle of FCR.
  • Intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen.
  • ECOG score of <=1.
  • Adequate coagulation, renal, & hepatic function at Screening as follows:

    • Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
    • AST & 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.
  • Adequate bone marrow (BM) independent of any growth factor support (with the exception of subjects with BM heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:

    • ANC >= 1000/µL;
    • Platelets >= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening);
    • Hemoglobin >= 9.0 g/dL.
  • History of autologous BM transplant must be > 6 mos post transplant (prior to the 1st dose of study drug) & have adequate BM independent of any growth factor support (with the exception of subjects with BM that is heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:

    • ANC >= 1500/µL;
    • Platelets >= 125,000/mm3;
    • Hemoglobin >= 10.0 g/dL.
  • Female subjects must be surgically sterile, postmenopausal (at least 1 year), or have negative results on a pregnancy test.
  • All female subjects not surgically sterile or postmenopausal (at least 1 year) & non-vasectomized male subjects must practice birth control.

Exclusion Criteria:

  • History/clinically suspicious for cancer-related CNS disease.
  • Undergone allogeneic stem cell transplant.
  • Undergone autologous stem cell transplant w/i 6 mos prior to 1st dose.
  • History/predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos 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 yr prior to 1st dose.
  • Currently receiving/requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications used to maintain the patency of a central IV catheter.
  • Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
  • Positive for HIV, Hepatitis B, or Hepatitis C.
  • Previous or current malignancies w/i the last 3 yrs:

    • except adequately treated in situ carcinoma of the cervix uteri;
    • basal or squamous cell carcinoma;
    • in situ carcinoma of the bladder;
    • or previous malignancy confined and surgically resected with curative intent.
  • Has Prolymphocytic leukemia or Richter's transformation to an aggressive B-cell malignancy.
  • Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection or diagnosis of fever and neutropenia w/i 1 week prior to study drug.
  • Prior exposure to ABT-263.
  • Received antibody therapy w/i 30 days prior to 1st dose.
  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, or any investigational therapy w/i 14 days prior to the 1st dose, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy.
  • Received steroid therapy for anti-neoplastic intent, w/i 7 days prior to the 1st dose with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids.
  • Received aspirin w/i 7 days prior to the 1st dose.
  • Consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose.
  • Females pregnant or breast-feeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00918450
M10-738
Not Provided
Sari Enschede, MD, Abbott Laboratories
Abbott
Genentech
Not Provided
Abbott
February 2010

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