Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT04517357
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2020-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722917', 'term': 'fluzoparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle', 'timeFrame': 'up to 28 days'}, {'measure': '(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib', 'timeFrame': 'up to 28 days'}, {'measure': '(Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients', 'timeFrame': 'Assessed up to a maximum of 20 months', 'description': "Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': '(Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients', 'timeFrame': 'Assessed up to a maximum of 20 months', 'description': "Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment"}], 'secondaryOutcomes': [{'measure': 'AEs+SAEs', 'timeFrame': 'from the first drug administration to within 30 days for the last treatment dose', 'description': 'Adverse Events and Serious Adverse Events'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'up to 20 months', 'description': "Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to 20 months', 'description': 'Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'up to 20 months', 'description': 'Time from documentation of tumor response to disease progression assessed among patients who had an objective response'}, {'measure': 'Response rate by RECIST 1.1 criteria', 'timeFrame': 'up to 20 months'}, {'measure': 'Response rate by GCIG CA125', 'timeFrame': 'up to 20 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.\n2. Patients must have received at least 2 previous platinum-containing regimens.\n3. At least one target lesion.\n4. ECOG performance status 0-1.\n5. Adequate bone marrow, kidney and liver function.\n\nExclusion Criteria:\n\n1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;\n2. Prior malignancy unless curatively treated and disease-free for \\> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;\n3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;\n4. Known to be human immunodeficiency virus positive;\n5. Known active hepatitis C virus, or known active hepatitis B virus;\n6. Untreated and/or uncontrolled brain metastases;\n7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;\n8. Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT04517357', 'briefTitle': 'A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients', 'orgStudyIdInfo': {'id': 'FZPL-II-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Lead-in or Parallel， Fluzoparib+Apatinib', 'description': 'Participants will receive Fluzoparib-Apatinib combination until progression', 'interventionNames': ['Drug: Fluzoparib+Apatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzoparib monotherapy', 'description': 'Participants will receive Fluzoparib monotherapy until progression', 'interventionNames': ['Drug: Fluzoparib']}, {'type': 'OTHER', 'label': 'Exploratory cohort: Fluzoparib+Apatinib', 'description': 'Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression', 'interventionNames': ['Drug: Fluzoparib+Apatinib']}], 'interventions': [{'name': 'Fluzoparib+Apatinib', 'type': 'DRUG', 'description': 'Fluzoparib-Apatinib combination', 'armGroupLabels': ['Safety Lead-in or Parallel， Fluzoparib+Apatinib']}, {'name': 'Fluzoparib', 'type': 'DRUG', 'description': 'Fluzoparib monotherapy', 'armGroupLabels': ['Fluzoparib monotherapy']}, {'name': 'Fluzoparib+Apatinib', 'type': 'DRUG', 'description': 'Fluzoparib-Apatinib combination', 'armGroupLabels': ['Exploratory cohort: Fluzoparib+Apatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}