Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT00661167
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of ABI-007 for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-16', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'During chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'During chemotherapy'}, {'measure': 'Progression-free survival', 'timeFrame': 'Until progression'}, {'measure': 'Overall survival', 'timeFrame': 'Over a year form randomaization'}, {'measure': 'Disease control rate', 'timeFrame': 'Duration chemoterapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '24716542', 'type': 'DERIVED', 'citation': 'Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed gastric adenocarcinoma\n* Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence\n* Age: 20 - 74\n* At least one measurable lesion by RECIST criteria\n\nExclusion Criteria:\n\n* History of Taxans use\n* Patients with another active malignancy\n* Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)\n* Chronic treatment with steroids'}, 'identificationModule': {'nctId': 'NCT00661167', 'briefTitle': 'Phase II Study of ABI-007 for Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.', 'orgStudyIdInfo': {'id': 'Taiho10041040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ABI-007', 'interventionNames': ['Drug: ABI-007']}], 'interventions': [{'name': 'ABI-007', 'type': 'DRUG', 'description': 'ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '791- 0280', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Shikoku Cancer Center', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '811- 1395', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'National Kyusyu Cancer Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '228-8520', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University East Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '781- 855', 'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Health Sciences Center', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '384-0301', 'city': 'Saku', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare', 'geoPoint': {'lat': 36.21667, 'lon': 138.48333}}, {'zip': '569- 8686', 'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical College Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '350-1298', 'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama International medical center-comprehensive cancer center, Saitama Medical University', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '411- 8777', 'city': 'Sunto', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center'}, {'zip': '933- 8555', 'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Kouseiren Takaoka Hospital', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}], 'overallOfficials': [{'name': 'Nagahiro Saijo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kinki University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}