Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-10 @ 3:21 PM
Study NCT ID:
NCT03137758
Status:
TERMINATED
Last Update Posted:
2020-03-09
First Post:
2017-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of Serum Cytoine IL-6', 'timeFrame': 'up to 2 years', 'description': 'Blood based biomarker'}, {'measure': 'Measurement of Urine Polyamines', 'timeFrame': 'up to 2 years', 'description': 'Urine based biomarker'}], 'primaryOutcomes': [{'measure': 'Toxicities and Adverse Events', 'timeFrame': '28 days', 'description': 'determined by type and severity using the most recent version of the CTCAE criteria'}], 'secondaryOutcomes': [{'measure': 'Response', 'timeFrame': 'up to 2 years', 'description': 'a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria'}, {'measure': 'Toxicities and adverse events', 'timeFrame': 'up to 2 years', 'description': 'determined by type and severity using the most recent version of the CTCAE criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration-Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed diagnosis of metastatic CRPC\n* standard of care androgen deprivation treatment\n* castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)\n* progressive disease while receiving androgen deprivation therapy\n* previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria\n* adequate hematologic, renal and hepatic function\n* KPS of ≥ 70 or ECOG of 0 to 1\n\nExclusion Criteria:\n\n* pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology\n* use of opiate analgesics for prostate cancer pain within 4 week of treatment start\n* more than one sequential second generation AR-directed therapy\n* received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks\n* history of bleeding disorder\n* history of seizure disorder\n* concomitant use of therapeutic anticoagulation\n* history of or current cardiac issues\n* received external beam radiation therapy within 4 weeks\n* CTCAE Grade \\> 2 neuropathy'}, 'identificationModule': {'nctId': 'NCT03137758', 'briefTitle': 'A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pellficure Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'PCUR101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Level 1 (50 mg) PCUR-101', 'description': 'Starting Dose, 3+3 Cohort Design', 'interventionNames': ['Drug: PCUR - 101']}, {'type': 'EXPERIMENTAL', 'label': 'Level 2 (100 mg) PCUR-101', 'interventionNames': ['Drug: PCUR - 101']}, {'type': 'EXPERIMENTAL', 'label': 'Level 3 (150 mg) PCUR-101', 'interventionNames': ['Drug: PCUR - 101']}, {'type': 'EXPERIMENTAL', 'label': 'Level 4 (200 mg) PCUR-101', 'interventionNames': ['Drug: PCUR - 101']}, {'type': 'EXPERIMENTAL', 'label': 'Level 5 (250 mg) PCUR-101', 'interventionNames': ['Drug: PCUR - 101']}, {'type': 'EXPERIMENTAL', 'label': 'Level 6 (300 mg) PCUR-101', 'interventionNames': ['Drug: PCUR - 101']}], 'interventions': [{'name': 'PCUR - 101', 'type': 'DRUG', 'description': 'PCUR-101 Capsules 25 mg are solid dosage forms for oral administration', 'armGroupLabels': ['Level 1 (50 mg) PCUR-101', 'Level 2 (100 mg) PCUR-101', 'Level 3 (150 mg) PCUR-101', 'Level 4 (200 mg) PCUR-101', 'Level 5 (250 mg) PCUR-101', 'Level 6 (300 mg) PCUR-101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pellficure Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}