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Renal Cell CarcinomaPhase 2NCT04535687

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

A Phase 2 study testing Fluzoparib in people with Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Fluzoparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
17 Dec 2020to 12 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

Being tested
Fluzoparib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluzoparibDrug

    Fluzoparib

Study groups in NCT04535687
Study groupRoleWhat they receive
Treatment groupExperimentalFluzoparib alone
Receives: Drug: Fluzoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate（ORR）

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

    Measured: three months

Secondary outcomes (4)

  1. radiographic progression free survival（rPFS）

    the time frame from the first day of fluzoparib to the date of radiographic confirmed progressive disease or death which one occurrs first

    Measured: six months

  2. overall survival（OS）

    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

    Measured: eighteen months

  3. time to progression（TTP）

    the time frame from the first day of fluzoparib to the date of confirmed progressive

    Measured: six months

  4. AE

    Number of Adverse Events, Grade 3 or higher as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start17 Dec 2020
  3. Primary completion12 Jun 2023
  4. Study completion12 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535687
Sponsor's protocol ID
RCC-MUL-IIT-FZPL
Status last verified
Jun 2023
First submitted
28 Aug 2020
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib in people with Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate（ORR） (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

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