Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT00225550
Status:
TERMINATED
Last Update Posted:
2007-08-06
First Post:
2005-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541294', 'term': 'N-Ac-CHAVC-NH2'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-03', 'studyFirstSubmitDate': '2005-09-22', 'studyFirstSubmitQcDate': '2005-09-22', 'lastUpdatePostDateStruct': {'date': '2007-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Cancer;', 'Tumors;', 'Neoplasms;', 'Anticarcinogenic Agents;', 'Antineoplastic Agents;', 'Cadherins'], 'conditions': ['Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.adherex.com', 'label': 'Adherex Technologies Inc. Corporate Homepage'}]}, 'descriptionModule': {'briefSummary': 'N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Signed written informed consent\n* Male and female patients \\> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists\n* Clinically or radiologically documented measurable disease.\n* Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue\n* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)\n\nExclusion criteria:\n\n* Receipt of ADH-1 prior to this clinical study\n* Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry\n* History of primary brain tumors or brain metastases\n* History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.\n* Stroke, major surgery, or other major tissue injury within 30 days before study entry\n* History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states'}, 'identificationModule': {'nctId': 'NCT00225550', 'briefTitle': 'A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adherex Technologies, Inc.'}, 'officialTitle': 'Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)', 'orgStudyIdInfo': {'id': 'Adherex Protocol AHX-01-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ADH -1 (Exherin™)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adherex Technologies, Inc.', 'class': 'INDUSTRY'}}}}