Fluzoparib in Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

NCT04535687 | Completed Phase 2

• 1 other identifier: RCC-MUL-IIT-FZPL
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to prospectively assess the safety and efficiency of Fluzoparib in metastatic non-clear cell renal cell carcinoma

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate（ORR）

  the proportion of patients with CR, PR, and SD in the group（RECIST1.1）

  three months

Secondary Outcomes (4)

• radiographic progression free survival（rPFS）

  six months

• overall survival（OS）

  eighteen months

• time to progression（TTP）

  six months

• AE

  2 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Fluzoparib alone

Drug: Fluzoparib

Interventions

Fluzoparib DRUG

Fluzoparib

Treatment group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hongqian Guo, Phd

  Department of Urology, Drum Tower Hospital, Medical School of Nanjing University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: December 17, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

CN (1)