Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-29 @ 12:44 AM
Study NCT ID:
NCT00918450
Status:
WITHDRAWN
Last Update Posted:
2010-02-26
First Post:
2009-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C528561', 'term': 'navitoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'whyStopped': 'Sponsor has decided to not proceed with this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-25', 'studyFirstSubmitDate': '2009-05-22', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'monthly (at a minimum)'}, {'measure': 'Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263.', 'timeFrame': 'Every 3 months'}], 'secondaryOutcomes': [{'measure': 'Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL.', 'timeFrame': 'Every 3 months'}, {'measure': '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 .', 'timeFrame': 'Every 3 months'}, {'measure': '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.', 'timeFrame': 'Every 3 months'}]}, 'conditionsModule': {'conditions': ['B-cell Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>= 18 yrs of age, have B-cell CLL, failed at least 1 prior fludarabine-containing regimen.\n* 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.\n* Intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen.\n* ECOG score of \\<=1.\n* Adequate coagulation, renal, \\& hepatic function at Screening as follows:\n\n * Serum creatinine \\<= 2.0 mg/dL or calculated creatinine clearance \\>= 50 mL/min;\n * AST \\& ALT \\<= 3.0 x ULN;\n * Bilirubin \\<= 1.5 x ULN.\n* Gilbert's Syndrome may have a Bilirubin \\> 1.5 x ULN; aPTT, PT, not to exceed 1.2 x ULN.\n* 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:\n\n * ANC \\>= 1000/µL;\n * Platelets \\>= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening);\n * Hemoglobin \\>= 9.0 g/dL.\n* 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:\n\n * ANC \\>= 1500/µL;\n * Platelets \\>= 125,000/mm3;\n * Hemoglobin \\>= 10.0 g/dL.\n* Female subjects must be surgically sterile, postmenopausal (at least 1 year), or have negative results on a pregnancy test.\n* All female subjects not surgically sterile or postmenopausal (at least 1 year) \\& non-vasectomized male subjects must practice birth control.\n\nExclusion Criteria:\n\n* History/clinically suspicious for cancer-related CNS disease.\n* Undergone allogeneic stem cell transplant.\n* Undergone autologous stem cell transplant w/i 6 mos prior to 1st dose.\n* History/predisposing condition of bleeding or currently exhibits signs of bleeding.\n* Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos prior to 1st dose.\n* Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.\n* Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 yr prior to 1st dose.\n* 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.\n* Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.\n* Positive for HIV, Hepatitis B, or Hepatitis C.\n* Previous or current malignancies w/i the last 3 yrs:\n\n * except adequately treated in situ carcinoma of the cervix uteri;\n * basal or squamous cell carcinoma;\n * in situ carcinoma of the bladder;\n * or previous malignancy confined and surgically resected with curative intent.\n* Has Prolymphocytic leukemia or Richter's transformation to an aggressive B-cell malignancy.\n* 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.\n* Prior exposure to ABT-263.\n* Received antibody therapy w/i 30 days prior to 1st dose.\n* 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.\n* 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.\n* Received aspirin w/i 7 days prior to the 1st dose.\n* Consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose.\n* Females pregnant or breast-feeding."}, 'identificationModule': {'nctId': 'NCT00918450', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'M10-738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ABT-263']}], 'interventions': [{'name': 'ABT-263', 'type': 'DRUG', 'description': 'Continuous dosing until disease progression using one of the following formulations:\n\n25 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', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Sari Enschede, MD', 'oldOrganization': 'Abbott Laboratories'}}}}