Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01137916
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2010-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Imatinib in Desmoid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018222', 'term': 'Desmoid Tumors'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-progression rate after 6 months of treatment', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Non-progression rate after 12 and 24 months of treatment', 'timeFrame': '12 and 24 months'}, {'measure': 'Response rate', 'timeFrame': '12 and 24 months'}, {'measure': 'Progression-free survival (PFS) and overall survival (OS)', 'timeFrame': '12 and 24 months'}, {'measure': 'Recording of patient quality of life', 'timeFrame': '12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aggressive Fibromatosis', 'Desmoid Tumor']}, 'referencesModule': {'references': [{'pmid': '28282612', 'type': 'DERIVED', 'citation': 'Kasper B, Gruenwald V, Reichardt P, Bauer S, Rauch G, Limprecht R, Sommer M, Dimitrakopoulou-Strauss A, Pilz L, Haller F, Hohenberger P. Imatinib induces sustained progression arrest in RECIST progressive desmoid tumours: Final results of a phase II study of the German Interdisciplinary Sarcoma Group (GISG). Eur J Cancer. 2017 May;76:60-67. doi: 10.1016/j.ejca.2017.02.001. Epub 2017 Mar 8.'}, {'pmid': '26861905', 'type': 'DERIVED', 'citation': 'Kasper B, Gruenwald V, Reichardt P, Bauer S, Hohenberger P, Haller F. Correlation of CTNNB1 Mutation Status with Progression Arrest Rate in RECIST Progressive Desmoid-Type Fibromatosis Treated with Imatinib: Translational Research Results from a Phase 2 Study of the German Interdisciplinary Sarcoma Group (GISG-01). Ann Surg Oncol. 2016 Jun;23(6):1924-7. doi: 10.1245/s10434-016-5132-4. Epub 2016 Feb 9.'}], 'seeAlsoLinks': [{'url': 'http://www.gisg.de', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histological confirmed aggressive fibromatosis (desmoid tumor)\n* Measurable disease according to the RECIST criteria\n* Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging\n* No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required\n* No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity\n* Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible\n* Age \\> or = 18 years\n* WHO PS \\< or = 1\n* Effective contraception during study medication\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Surgical intervention \\< 4 weeks\n* Prior therapy with imatinib\n* Pregnancy or lactation\n* Severe hepatic dysfunction\n* Known allergic reaction to imatinib or one of its components\n* The following laboratory values: Absolute neutrophil count \\< 1.5 x 103/mm3, Platelets \\< 100,000/mm3, Serum creatinine \\> or = 2.5 mg/dl, SGOT and/or SGPT \\> 2.5 x ULN (upper limit of normal), Total bilirubin \\> 1.5 x ULN\n* Participation in another study (four weeks before and during the study)\n* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix'}, 'identificationModule': {'nctId': 'NCT01137916', 'briefTitle': 'Study to Evaluate Imatinib in Desmoid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss', 'orgStudyIdInfo': {'id': 'CSTI571BDE70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'drug', 'description': 'Imatinib 800 mg', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Glivec'], 'description': '800 mg', 'armGroupLabels': ['drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'University of Heidelberg, Mannheim University Medical Center', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Bernd Kasper, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Mannheim University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Bernd Kasper', 'investigatorAffiliation': 'Heidelberg University'}}}}