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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00918450
Other study ID # M10-738
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 22, 2009
Last updated February 25, 2010
Start date March 2010

Study information

Verified date February 2010
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 150
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Abbott Genentech, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. monthly (at a minimum) Yes
Primary Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263. Every 3 months No
Secondary Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL. Every 3 months No
Secondary 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 . Every 3 months No
Secondary 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. Every 3 months No
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