Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT00741234
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2008-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2008-08-22', 'studyFirstSubmitQcDate': '2008-08-22', 'lastUpdatePostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks', 'timeFrame': 'Throughout the study'}, {'measure': 'To determine the dose limiting toxicities of SB939', 'timeFrame': 'Throughout the study'}, {'measure': 'To determine the pharmacokinetic profile of SB939', 'timeFrame': 'Throughout the study'}, {'measure': 'To assess histone acetylation in PBMC and other biomarkers', 'timeFrame': 'Throughout the study'}, {'measure': 'To document anti-tumor activity', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SB939', 'Myelodysplastic Syndrome', 'Combination with azacitidine', 'Solid malignancies', 'Hematologic malignancies', 'HDAC inhibitor', 'Refractory to standard therapy'], 'conditions': ['Solid Tumors', 'Hematologic Malignancies', 'Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nArms A \\& B:\n\n* Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;\n* ECOG performance status (PS) 0-2;\n* Patients must have adequate non-hematologic organ system function.\n\nArm C:\n\n* Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;\n* Have not been treated with azacitidine and are a candidate for treatment with azacitidine;\n* ECOG performance status (PS) 0-2;\n* Patients must have adequate non-hematologic organ system function.'}, 'identificationModule': {'nctId': 'NCT00741234', 'briefTitle': 'A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine', 'organization': {'class': 'INDUSTRY', 'fullName': 'S*BIO'}, 'officialTitle': 'A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'SB939-2006-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Advanced solid tumors', 'interventionNames': ['Drug: SB939']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Advanced hematologic malignancies', 'interventionNames': ['Drug: SB939']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Myelodysplastic Syndrome', 'interventionNames': ['Drug: SB939', 'Drug: Azacitidine']}], 'interventions': [{'name': 'SB939', 'type': 'DRUG', 'description': 'SB939 taken orally in a 4-week cycle.', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['Vidaza'], 'description': 'Azacitidine taken orally with SB939 in a 4-week cycle', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '160610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'George Wilding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Boon Cher Goh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}, {'name': 'Han Chong Toh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}, {'name': 'Charles Chuah, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}, {'name': 'Guillermo Garcia-Manero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S*BIO', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}