Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-01 @ 5:15 PM
Study NCT ID:
NCT00405561
Status:
TERMINATED
Last Update Posted:
2013-03-20
First Post:
2006-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-19', 'studyFirstSubmitDate': '2006-11-29', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival;at 18 weeks after registration', 'timeFrame': '2010'}], 'secondaryOutcomes': [{'measure': 'Best overall response rate (ORR, CR and PR) within 18 weeks after registration', 'timeFrame': '2010'}, {'measure': 'Progression Free survival time (PFS), over complete observation period', 'timeFrame': '2010'}, {'measure': 'Overall Survival (OS) time', 'timeFrame': '2010'}, {'measure': 'Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)', 'timeFrame': '2010'}, {'measure': 'Safety and Tolerability', 'timeFrame': '2010'}]}, 'conditionsModule': {'keywords': ['Advanced Colorectal Carcinoma'], 'conditions': ['Colorectal Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.alpiniainstitute.com', 'label': 'now legally responsible for this study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.\n\nThe primary endpoint is progression free survival rate at 18 weeks after registration', 'detailedDescription': 'The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer confirmed by histology or cytology\n* At least one measurable lesion\n* Advanced disease refractory to standard therapy or for which no standard therapy exists\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma\n* Body weight below 45 kg\n* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control\n* Confirmed diagnosis of HIV\n* Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II\n* Chemotherapy or radiotherapy less than 4 weeks prior to entry\n* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)\n* Participation in a clinical trial less than 30 days prior to entry in the study'}, 'identificationModule': {'nctId': 'NCT00405561', 'briefTitle': 'Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003', 'organization': {'class': 'INDUSTRY', 'fullName': 'Auron Healthcare GmbH'}, 'officialTitle': 'A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003', 'orgStudyIdInfo': {'id': 'AMT/P2GI/001 Part III'}, 'secondaryIdInfos': [{'id': 'LC001Auron2005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMT2003', 'interventionNames': ['Drug: AMT2003']}], 'interventions': [{'name': 'AMT2003', 'type': 'DRUG', 'armGroupLabels': ['AMT2003']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79111', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Clinic SanaFontis', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Joachim Drevs, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic Sanafontis, Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auron Healthcare GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}