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Ovarian CancerPhase 2NCT06161272

Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi

A Phase 2 study testing Fluzoparib and Fluzoparib+Apatinib in people with Ovarian Cancer and High Grade Serous Adenocarcinoma of Ovary, run by Guangxi Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Fluzoparib and Fluzoparib+Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
10 Dec 2023to 10 Jan 2026
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily joined the study and signed the informed consent.
  • Female, 18-75 years (calculated on date of signing informed consent).
  • Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
  • Mixed tumors: contain high-grade serous component or endometrioid components over 50%.
  • Disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy.
  • Prior treatment with ≥2 platinum-containing chemotherapy regimens and disease remission (complete or partial response) at the end of the last platinum chemotherapy, which lasted until study administration, must be randomized to enrollment and start trial drug administration within 8 weeks from the last chemotherapy administration.
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  • Preoperative neoadjuvant chemotherapy and postoperative chemotherapy counted as 1 chemotherapy treatment regimen.
  • The last chemotherapy must be a platinum-based chemotherapy regimen.
  • Patient must have received at least 4 cycles of treatment for the last platinum-based chemotherapy, during or after platinum-containing chemotherapy, concurrent use of other investigational drugs and treatment other than endocrine therapy drugs are not permitted.
  • A detectable lesion or CA-125 ≥2 ×ULN is required before the last platinum treatment.
  • The imaging results showed CR or PR during the last platinum-containing regimen, CA125 decreased to within the ULN or ≥90% from pre-treatment level during treatment and CA125 remained <1xULN or did not increase by >10% in 7 days before the first treatment.
  • If no lesion is assessed prior to chemotherapy, CA125 should be alleviated to the ULN during treatment and maintained at <1xULN for 7 days prior to the first treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The duration of continuous PARPi treatment during the previous maintenance treatment period was ≥6 months.
  • Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted)
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L
  • Platelets ≥100×10^9/L
  • Hemoglobin ≥9g/dL
  • Serum albumin ≥3g/dL
  • Total bilirubin ≤1.5 ×ULN
  • AST and ALT ≤3 × ULN, and for patients with liver metastases, AST and ALT levels ≤5× ULN
  • Serum creatinine ≤1.5 × ULN.
  • Patients with potential fertility must have had a negative blood or urine pregnancy test within 72 hours prior to the first dose, are not breastfeeding, and must agree to use a medically approved contraceptive (e.g., intrauterine device, birth control pill or condom) for the duration of the trial and for a period of 6 months after the last administration of fluzoparib or 2 months after the last administration of apatinib, whichever is longer.

Who cannot join

  • Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry; Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix or breast cancer without recurrence over 3 years allowed.
  • The expected survival is less than three months.
  • Participants with untreated central nervous system metastases
  • patients who had previously received systemic, radical brain or meninges metastases (radiotherapy or surgery), had been stable for at least 1 month on imaging, had stopped systemic sex hormone therapy (dose >10mg/ day or other therapeutic hormones) for more than 2 weeks, and had no clinical evidence could be included.
  • Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.
  • Intestinal obstruction within 3 months.
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  • The urine protein ≥ ++ and 24-hour urine protein level > 1.0g.
  • 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.
  • Uncontrolled heart clinical symptoms or diseases, such as :(1) NYHA 2 or more heart failure, (2) Unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Ventricular arrhythmias requiring intervention, (5) QTc>470ms.
  • Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic therapy are allowed to receive low-dose low-molecular weight heparin or oral aspirin preventive anticoagulant therapy during the study.
  • Significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc., within the first 3 months of the randomization. If fecal occultation blood is positive at baseline, gastroscopy should be performed if still positive after reexamination.
  • Active ulcers, unhealed wounds or fractures.
  • Uncontrolled hypertension by antihypertensive medication (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg).
  • Any bleeding event with grade 2 or higher in CTCAE 5.0 within 4 weeks prior randomization.
  • Active infection or unexplained fever >38.5 degrees during screening or before first treatment.
  • Participants with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive, HCV virus copy number > upper limit of normal).
  • Received radiotherapy, chemotherapy, hormone therapy, or molecular targeted therapy, less than 4 weeks after the completion of the last dose or less than 5 drug half-lives before the study for oral molecular targeted drug; adverse events caused by previous treatment (except hair loss) and not recover to ≤1 degree (CTCAE 5.0).
  • Arteriovenous thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 6 months.
  • History of hereditary or acquired bleeding or coagulation disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, etc.).
  • Need receive other systemic anti-tumor therapy during the study period.
  • According to the investigators' judgment the subjects had other factors that might have led to the forced termination of the study.

Trial locations and contacts

1 site in 1 country.

Li Li contact

13878113406

lili@gxmu.edu.cn

China1 site

  • Affiliated Tumor Hospital of Guangxi Medical University.

    Nanning, Guangxi

    Li Li, 13878113406, lili@gxmu.edu.cn

Other trials in China

About this study

Official title: A Randomized, Multicenter, Noncomparative Clinical Study of Fluzoparib With or Without Apatinib for Maintenance Therapy in PARPi-pretreated Platinum-sensitive Recurrent Ovarian Cancer

This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib.

Being tested
Fluzoparib, Fluzoparib+Apatinib
Keywords
ovarian cancer, PARP inhibitors, Flzuoparib, Antiangiogenic agents, Apatinib
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • FluzoparibDrug

    single

  • Fluzoparib+ApatinibDrug

    combination

Study groups in NCT06161272
Study groupRoleWhat they receive
Arm1：FluzoparibExperimentalFluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle.
Receives: Drug: Fluzoparib
Arm2：Fluzoparib + apatinibExperimentalFluzoparib capsule: oral administration, 2 capsules/dose (100 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle. Apatinib: oral administration, 1 tablet/dose (375 mg/tablet), once a day, it is recommended to take orally within 0.5h after breakfast, continuous administration. Every 4 weeks is a treatment cycle.
Receives: Drug: Fluzoparib+Apatinib

What is being measured

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

  1. Progression-free Survival (PFS)

    Time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first.

    Measured: from the randomization up to 2 years

Secondary outcomes (7)

  1. Overall survival (OS)

    Time from the date of randomization to the date of death due to any cause.

    Measured: from the randomization up to 3 years

  2. Objective Response Rate (ORR)

    ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: from the randomization up to two years

  3. Disease control rate (DCR)

    the proportion of patients with a best overall response of confirmed complete or partial response or stable disease based on RECIST v1.1.

    Measured: from the randomization up to two years

  4. Time to start of first subsequent therapy or death (TFST)

    TFST is defined as the time from the randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.

    Measured: from the randomization up to 3 years

  5. Time to start of second subsequent therapy or death (TSST)

    TSST is defined as the time from the randomization to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

    Measured: from the randomization up to 3 years

  6. Time to failure (TTF）by RECIST

    Time to treatment failure by RECIST v. 1.1 or CA-125 or death is defined as the time from the randomization to the date of RECIST progression or death by any cause, whichever occurs first.

    Measured: from the randomization up to 3 years

  7. Safety and tolerability

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    Measured: from the randomization up to 3 years

Timeline

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

  1. First posted7 Dec 2023
  2. Study start10 Dec 2023 (estimated)
  3. Primary completion10 Mar 2025 (estimated)
  4. Study completion10 Jan 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161272
Sponsor's protocol ID
CS2023(166)
Status last verified
Nov 2023
First submitted
30 Nov 2023
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib and Fluzoparib+Apatinib in people with Ovarian Cancer and High Grade Serous Adenocarcinoma of Ovary, run by Guangxi Medical University 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 23 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 7 Dec 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?

Results are not available in the source record.

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

Contact Li Li (13878113406, lili@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: from the randomization up to 2 years). 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 NCT06161272.

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 7 Dec 2023.

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