Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-05 @ 7:14 PM
Study NCT ID:
NCT03119467
Status:
TERMINATED
Last Update Posted:
2019-12-27
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716749', 'term': 'RP4010'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Study has been stopped after reviewing PK and safety results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-26', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) Determination', 'timeFrame': '28 days', 'description': 'To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax).', 'timeFrame': '24 hrs', 'description': 'To assess the Maximum Plasma Concentration (Cmax).'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': '24 hrs', 'description': 'To assess the Area under the plasma concentration versus time curve (AUC)'}, {'measure': 'Anti-tumor activity-Overall response rate (ORR)', 'timeFrame': '2 months', 'description': 'To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas', 'detailedDescription': 'Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).\n\nPharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).\n\nEfficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Refractory to or relapsed after at least 1 prior treatment line.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Patients must be ≥18 years of age\n* Able to give a written informed consent.\n\nExclusion Criteria:\n\n* Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).\n* Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection\n* Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.\n* Patients with graft versus-host disease (GVHD)\n* Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .\n* Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV);\n* Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec;\n* Patient with angina not well-controlled by medication;\n* Women who are pregnant or lactating."}, 'identificationModule': {'nctId': 'NCT03119467', 'briefTitle': 'Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhizen Pharmaceuticals SA'}, 'officialTitle': 'A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas', 'orgStudyIdInfo': {'id': 'RP4010-1601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'RP4010 to be administered', 'interventionNames': ['Drug: RP4010']}], 'interventions': [{'name': 'RP4010', 'type': 'DRUG', 'description': 'Escalating doses starting at 25 mg', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pindara Private Hospital', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '4120', 'city': 'Greenslopes', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Brisbane Clinic for Lymphoma, Myeloma and Leukaemia', 'geoPoint': {'lat': -27.50815, 'lon': 153.04951}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Epworth HealthCare', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhizen Pharmaceuticals SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}