Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-14 @ 11:15 AM
Study NCT ID:
NCT03863860
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2019-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2019-03-03', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients', 'timeFrame': 'up to 2 years', 'description': 'Defined as progression free survival per RECIST 1.1 criteria'}, {'measure': 'Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant', 'timeFrame': 'up to 2 years', 'description': 'Defined as progression free survival per RECIST 1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Progression free survival(PFS) in relapsed ovarian cancer patients', 'timeFrame': 'up to 2 years', 'description': 'PFS is Progression-Free-Survival per RECIST 1.1 criteria'}, {'measure': 'Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria', 'timeFrame': 'up to 2 years', 'description': 'TTP is Time to Progression'}, {'measure': 'Chemotherapy free interval (CFI) CFI', 'timeFrame': 'up to 2 years', 'description': 'CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)'}, {'measure': 'overall survival(OS)', 'timeFrame': 'up to 3 years', 'description': 'OS is the time interval from the start of treatment to death due to any reason or lost of follow-up'}, {'measure': 'Objective Response Rate', 'timeFrame': 'At baseline,at the time point of every 12 weeks, up to 2 years', 'description': 'Objective Response Rate complete or partial response per RECIST 1.1 criteria'}, {'measure': 'Adverse Events(AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'from the first drug administration to within 30 days for the last treatment dose', 'description': 'assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '35404684', 'type': 'DERIVED', 'citation': 'Li N, Zhang Y, Wang J, Zhu J, Wang L, Wu X, Yao D, Wu Q, Liu J, Tang J, Yin R, Lou G, An R, Zhang G, Xia X, Li Q, Zhu Y, Zheng H, Yang X, Hu Y, Zhang X, Hao M, Huang Y, Lin Z, Wang D, Guo X, Yao S, Wan X, Zhou H, Yao L, Yang X, Cui H, Meng Y, Zhang S, Qu J, Zhang B, Zou J, Wu L. Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial. J Clin Oncol. 2022 Aug 1;40(22):2436-2446. doi: 10.1200/JCO.21.01511. Epub 2022 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)\n2. Completion of ≥2 previous platinum-containing regimens\n3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator\n4. Ability to be randomized ≤8 weeks after last dose of platinum\n\nExclusion Criteria:\n\n1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor\n2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(\\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).\n3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.'}, 'identificationModule': {'nctId': 'NCT03863860', 'briefTitle': 'A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'FZPL-Ⅲ-301-OC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluzoparib capsules, 50mg per capsule', 'description': 'Fluzoparib capsules, PO', 'interventionNames': ['Drug: Fluzoparib capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules, 50mg per capsule', 'description': 'Placebo capsules, PO', 'interventionNames': ['Drug: Placebo capsules']}], 'interventions': [{'name': 'Fluzoparib capsules', 'type': 'DRUG', 'otherNames': ['SHR-3162'], 'description': 'Fluzoparib capsules', 'armGroupLabels': ['Fluzoparib capsules, 50mg per capsule']}, {'name': 'Placebo capsules', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo capsule', 'armGroupLabels': ['Placebo capsules, 50mg per capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lingying Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}