- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535687
Fluzoparib in Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
June 12, 2023 updated by: Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
This trial aims to prospectively assess the safety and efficiency of Fluzoparib in metastatic non-clear cell renal cell carcinoma
Study Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 18 years of age or older
- Histological proof of metastatic non-clear cell renal cell carcinoma (AJCC Stage IV),Must have measurable disease as defined by RECIST 1.1 criteria
- Somatic or germline mutation in homologous recombination gene from tissue, saliva or blood-based genetic test
- At least one prior treatment with a Tyrosine Kinase Inhibitor,the progress of soft tissue lesions need to be consistent with RECIST1.1
- Any number of prior systemic therapies is allowed (cytokine, anti-angiogenic, mTOR, immune checkpoint blockage or clinical trial)
- Participants must have a life expectancy ≥ 3 months
- ECOG PS ≤ 1
- Participants must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment as defined below:
- Hemoglobin ≥ 100 g/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN
- Blood Urea Nitrogen(BUN)/Creatinine(Cr)≤ 1.5 x institutional ULN
- Appropriate measures should be taken for contraception for women in childbearing period and man with reproductive capacity
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy > 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients with symptomatic uncontrolled brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
- Judged by investigator, the subjects had other factors that could lead to the termination of the study such as with other serious disease (including mental illness) need to merge treatment, serious abnormal laboratory values, family and social factors maybe affect the safety or data collection
- Breast feeding women
- Use of any prohibited concomitant medications within the prior 2 weeks
- Involvement in the planning and/or conduct of the study
- Participation in another clinical study with an investigational product during the last 4 weeks
- Patients receiving any systemic chemotherapy or radiotherapy within 4 weeks prior to study treatment
- Any previous treatment with PARP inhibitor, including fluzoparib
- Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II or worse heart failure;(2)unstable angina pectoris;(3)myocardial infarction occurred within 1 year;(4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; (5) QTc≥470ms
- Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting fluzoparib is 2 weeks
- Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting fluzoparib is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other agents
- Adverse events caused by previously accepted treatment(except hair loss ) have not recovered (grade 1 or baseline level) or less
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
- Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Poor medical risk due to a serious, uncontrolled non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan
- Congenital or acquired immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- Known hypersensitivity to fluzoparib or any of the excipients of the product
- Known active hepatitis (i.e. Hepatitis B:HBsAg positive,HBV DNA≥2000IU/ml or copy number≥10000/ml;Hepatitis B:HCV antibodies positive,copy number≥institutional ULN)
- Uncontrolled hypertension, defined as systolic blood pressure (BP) >= 150 millimeters of mercury (mmHg) or diastolic BP >= 100 mmHg with or without antihypertensive dication
- Packed red blood cells and/or platelet transfusions within the last 28 days prior to study entry
- Abnormal coagulation function(INR>2.0,PT>16s),hemorrhagic tendency or undergoing thrombolytic or anticoagulant therapy. The patient can receive low dose aspirin, low molecular weight heparin for precausion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Fluzoparib alone
|
Fluzoparib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate(ORR)
Time Frame: three months
|
the proportion of patients with CR, PR, and SD in the group(RECIST1.1)
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
radiographic progression free survival(rPFS)
Time Frame: six months
|
the time frame from the first day of fluzoparib to the date of radiographic confirmed progressive disease or death which one occurrs first
|
six months
|
overall survival(OS)
Time Frame: eighteen months
|
the time frame from the first day of fluzoparib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death
|
eighteen months
|
time to progression(TTP)
Time Frame: six months
|
the time frame from the first day of fluzoparib to the date of confirmed progressive
|
six months
|
AE
Time Frame: 2 years
|
Number of Adverse Events, Grade 3 or higher as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hongqian Guo, Phd, Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2020
Primary Completion (Actual)
June 12, 2023
Study Completion (Actual)
June 12, 2023
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 2, 2020
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 12, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Fluzoparib
Other Study ID Numbers
- RCC-MUL-IIT-FZPL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Cell Carcinoma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell CarcinomaUnited States, Taiwan, Australia
-
Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
-
Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
-
Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
-
AmgenCompletedRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Clear Cell Renal Carcinoma | Renal Cell AdenocarcinomaFrance, United States, Germany
Clinical Trials on Fluzoparib
-
Tianjin Medical University Cancer Institute and...RecruitingAdvanced HER2 Negative Breast Carcinoma | HRD+Breast CancerChina
-
wang shusenRecruitingAdvanced HER2 Negative Breast Carcinoma HRD+Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.UnknownAdvanced Pancreatic CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Peking University People's HospitalJiangsu Hengrui Pharmaceutical Co., Ltd.Enrolling by invitationGermline BRCA-mutated HER2-negative Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Adult SubjectsChina
-
Jiangsu HengRui Medicine Co., Ltd.307 Hospital of PLA; Peking University Cancer Hospital & InstituteCompletedAdvanced Solid MalignanciesChina
-
Atridia Pty Ltd.Completed
-
Atridia Pty Ltd.Completed