Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-04 @ 4:06 PM
Study NCT ID:
NCT00036257
Status:
COMPLETED
Last Update Posted:
2011-10-17
First Post:
2002-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'C439285', 'term': '(5-fluoro-2-methyl-1-(4-pyridyl)methylene-3-(N-benzyl)-indene)-acetamide hydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-14', 'studyFirstSubmitDate': '2002-05-08', 'studyFirstSubmitQcDate': '2002-05-08', 'lastUpdatePostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Chronic Lymphocytic Leukemia', 'Leukemia', 'CLL'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Relapsed or refractory chronic lymphocytic leukemia.\n2. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.\n3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.\n4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.\n5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.\n6. Expected remaining life span \\> or = three months.\n7. ECOG performance status 0 - 2.\n8. 18 years or of legal age.\n9. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.\n10. Negative serum pregnancy test, if fertile female.\n11. Willingness and ability to sign an informed consent document.\n\nExclusion Criteria:\n\n1. Evidence of CNS involvement.\n2. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.\n3. Previous therapy with Campath.\n4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.\n5. Concurrent immunotherapy.\n6. Concurrent use of steroids.\n7. Use of an investigational medication or device within 1 month of initiating study therapy.\n8. Patients who have had allogeneic bone marrow transplantation.\n9. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.\n10. AST or ALT \\> 2.5 times the upper limit of normal.\n11. Any condition or any medication which may interfere with the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT00036257', 'briefTitle': 'Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'orgStudyIdInfo': {'id': 'OSI-461-010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CP-461', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Centers of Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Regional Cancer Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center (US Oncology)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cell Pathways', 'class': 'INDUSTRY'}, {'name': 'OSI Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}