Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00073502
Status:
COMPLETED
Last Update Posted:
2006-02-22
First Post:
2003-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506644', 'term': '((S)-2-(5-(1,2-dihydro-3-methyl-1-oxobenzo(f)-quinazoline-9-yl)methyl)amino-1-oxo-2-isoindolynyl)-glutaric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'statusVerifiedDate': '2003-10', 'completionDateStruct': {'date': '2003-10'}, 'lastUpdateSubmitDate': '2006-02-17', 'studyFirstSubmitDate': '2003-11-21', 'studyFirstSubmitQcDate': '2003-11-24', 'lastUpdatePostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Gastroesophageal Adenocarcinoma', 'Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDocumented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age \\>= 18 years At least one target lesion\n\nExclusion Criteria:\n\nActive or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable'}, 'identificationModule': {'nctId': 'NCT00073502', 'briefTitle': 'Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'OSI Pharmaceuticals'}, 'officialTitle': 'A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction', 'orgStudyIdInfo': {'id': 'OSI-904-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OSI-7904L', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'B-3000 Leuven', 'country': 'Belgium', 'facility': 'Dept Internal Medicine Gastrointestinal Oncology Unit'}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'Avon', 'country': 'United Kingdom', 'facility': 'Bristol Haematology & Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'OX3 7LJ', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'ICRF Medical Oncology Unit', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Deanesly Centre', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'NICCTU, East Podium, C-Floor', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson Oncology Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LS16 6BB', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Cookridge Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Department of Medical Oncology', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OSI Pharmaceuticals', 'class': 'INDUSTRY'}}}}