Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT00618735
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C521963', 'term': '6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-27', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of BIIB021', 'timeFrame': 'As specified in protocol'}], 'secondaryOutcomes': [{'measure': 'PK and PD of BIIB021', 'timeFrame': 'As specified in protocol'}, {'measure': 'Antitumor activity', 'timeFrame': 'As specified in protocol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '24097863', 'type': 'BACKGROUND', 'citation': "Saif MW, Takimoto C, Mita M, Banerji U, Lamanna N, Castro J, O'Brien S, Stogard C, Von Hoff D. A phase 1, dose-escalation, pharmacokinetic and pharmacodynamic study of BIIB021 administered orally in patients with advanced solid tumors. Clin Cancer Res. 2014 Jan 15;20(2):445-55. doi: 10.1158/1078-0432.CCR-13-1257. Epub 2013 Oct 4."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.', 'detailedDescription': 'Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.\n\nAge greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.\n\nExclusion Criteria:\n\nPrior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.\n\nSubjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.'}, 'identificationModule': {'nctId': 'NCT00618735', 'briefTitle': 'Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '120ST103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects in Schedule A will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (Beginning at midnight).', 'interventionNames': ['Drug: BIIB021']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2.', 'interventionNames': ['Drug: BIIB021']}], 'interventions': [{'name': 'BIIB021', 'type': 'DRUG', 'otherNames': ['CNF2024'], 'description': 'Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.', 'armGroupLabels': ['1']}, {'name': 'BIIB021', 'type': 'DRUG', 'otherNames': ['CNF2024'], 'description': 'Twice daily dosing', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD', 'oldOrganization': 'Biogen Idec'}}}}