Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-05 @ 7:06 PM
Study NCT ID:
NCT02297802
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2014-11-26
First Post:
2014-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Patient IND for PD-0325901
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506614', 'term': 'mirdametinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2013-06'}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-24', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Prior Treatment With PD-0325901 With Ongoing Clinical Response']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior treatment with PD-0325901 with ongoing response\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02297802', 'briefTitle': 'A Single Patient IND for PD-0325901', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'A Phase I Single Patient IND for PD-0325901', 'orgStudyIdInfo': {'id': '130596 SHRP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PD-0325901', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Healthcare', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}