Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04921527
Status:
RECRUITING
Last Update Posted:
2024-10-18
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705608', 'term': 'chiauranib'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 454}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'assessed up to 1 years', 'description': 'From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first (Assessed by IRC)'}, {'measure': 'overall survival (OS)', 'timeFrame': 'assessed up to 2 years', 'description': 'OS is defined as the length of time from treatment to death from any cause'}], 'secondaryOutcomes': [{'measure': 'overall response rate (ORR)', 'timeFrame': 'assessed up to 2 years', 'description': 'ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}, {'measure': 'duration of response (DOR)', 'timeFrame': 'assessed up to 2 years', 'description': 'From the first date of response until the date of first documented progression'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'assessed up to 2 years', 'description': 'DCR is defined as the Proportion of participants in partial, complete or stable desease according to RECIST 1.1. criteria'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'assessed up to 2 years', 'description': 'QoL assessed by EORTC QLQ-OV28'}, {'measure': 'Toxicity according to NCI CTCAE v5.0 criteria', 'timeFrame': 'assessed up to 2 years', 'description': 'tolerance of the treatment based on AE occurrence according to NCI CTCAE v5.0 criteria'}, {'measure': 'PK parameters of paclitaxel, chiauranib and M345', 'timeFrame': 'assessed up to 2 years', 'description': 'PK parameters include but not limited to AUC, Cmax, Tmax etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'Relapsed or Refractory', 'Chiauranib', 'Paclitaxel']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.', 'detailedDescription': 'Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance.\n\nPatients will be randomized to receive treatment with either paclitaxel + Chiauranib or paclitaxel + placebo. Paclitaxel will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue Chiauranib or placebo until progression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to sign a written informed consent document .\n* Female, age ≥18 yrs and ≤70 yrs.\n* Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.\n* Patients with platinum refractory or platinum resistant ovarian cancer:\n\n * Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;\n * Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);\n * Radiological progression during the last treatment administered;\n * no more than 1 prior treatment regimens for recurrent disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least 1 lesion can be accurately measured, as defined by RECIST1.1.\n* Laboratory criteria are as follows:\n\n * Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;\n * Biochemistry test: serum creatinine(cr) \\<1.5×ULN; total bilirubin\\<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;\n * Coagulation test: International Normalized Ratio (INR) \\< 1.5, activeated partial thromboplasting time (APTT) \\<1.5×ULN\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.\n* Patients received weekly paclitaxel therapy.\n* Has known allegies to Chiauranib, paclitaxel or any of the excipients.\n* Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.\n* prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.\n* Treatment with an investigational agent/instrument within 28 days prior to first dose of study drug.\n* Any ongoing toxicity from prior anti-cancer therapy that is \\>Grade 1.\n* Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n* clinically significant central/peripheral nervous system disease.\n* Have uncontrolled or significant cardiovascular disease, including:\n\n * Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \\< 50% requiring treatment with agents during screening stage.\n * primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)\n * History of significant QT interval prolongation, or Corrected QT Interval (QTc) \\> 470 ms prior to study entry\n * Symptomatic coronary heart disease requiring treatment with agents\n * History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140/90 mmHg prior to study entry.\n * Other condition investigator considered inappropriate\n* Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.\n* CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment, history of immune-associated pneumonia after treatment of PD1/PDL1 inhibitor.\n* Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug or GI obstruction within the past 3 months.\n* Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.\n* Screening for HIV antibody positive.\n* Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.\n* Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* History of organ transplantation or allo-HSCT.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* Candidates with drug and alcohol abuse.\n* Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.\n* Any other condition which is inappropriate for the study in the opinion of the investigators.'}, 'identificationModule': {'nctId': 'NCT04921527', 'acronym': 'CHIPRO', 'briefTitle': 'Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chipscreen Biosciences, Ltd.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'CAR301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chiauranib plus weekly paclitaxel', 'description': 'Patients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most,Chiauranib is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.', 'interventionNames': ['Drug: chiauranib', 'Drug: Paclitaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo plus weekly paclitaxel', 'description': 'Patients receive the combined treatment of placebo plus paclitaxel, 21 days for a cycle, 6 cycles at most,placebo is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of placebo.', 'interventionNames': ['Drug: Placebo', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'chiauranib', 'type': 'DRUG', 'otherNames': ['CS2164'], 'description': '50mg orally once daily', 'armGroupLabels': ['Chiauranib plus weekly paclitaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '50mg orally once daily', 'armGroupLabels': ['placebo plus weekly paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax'], 'description': 'at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;', 'armGroupLabels': ['Chiauranib plus weekly paclitaxel', 'placebo plus weekly paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Wu, MD', 'role': 'CONTACT', 'phone': '13601772486'}, {'name': 'Xiaohua Wu, MD', 'role': 'CONTACT'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yu Chen', 'role': 'CONTACT', 'email': 'chenyu@chipscreen.com', 'phone': '8610-56102349'}], 'overallOfficials': [{'name': 'Xiaohua Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan university Shanghai cancer centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chipscreen Biosciences, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}