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Relapsed Ovarian CancerPhase 2NCT05479487

Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment

A Phase 2 study testing Fluzoparib+Apatinib and Fluzoparib Monotherapy in people with Relapsed Ovarian Cancer, run by Xiaohua Wu MD.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Ovarian Cancer
What is being tested?
Fluzoparib+Apatinib and Fluzoparib Monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 1 Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily joined the study and signed the informed consent
  • Patients ≥18 years of age.
  • Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
  • Mixed mullerian: contain high-grade serous component or endometrioid components over 50%.
  • Participant has received 2 or 3 previous lines of platinum-containing therapy and the last chemotherapy course contains platinum regimen.
  • Preoperative neoadjuvant chemotherapy and postoperative chemotherapy were considered as 1 line chemotherapy treatment.
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  • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy
  • Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum 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.
  • 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.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
  • Participant had prior treatment with PARP inhibitor in a maintenance setting:
  • For the BRCA1/2 cohort, the duration of first PARPi exposure must have been ≥18 months following a first line of chemotherapy or ≥12 months following a second line of chemotherapy.
  • For the non BRCA1/2 cohort, the duration of first PARPi exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second line of chemotherapy.
  • 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) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN
  • Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during and for 3 months after the study period; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.

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.
  • Untreated and/or uncontrolled brain metastases.
  • Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.
  • Intestinal obstruction within 3 months.
  • 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 3 months prior to the first administration;
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  • 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 ≥140mmHg 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.
  • Known to be human immunodeficiency virus positive; Known active hepatitis C virus, or known active hepatitis B virus.
  • 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.
  • Other factors that may cause the study to be terminated.

Trial locations and contacts

No sites are listed yet.

Xiaohua Wu, Ph.D., MD contact

+86 021-64175590

wu.xh@fudan.edu.cn

About this study

Official title: Fluzoparib Combined With Apatinib Versus Fluzoparib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Randomized, Open Label, Controlled, Multicenter Trial

This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).

Being tested
Fluzoparib+Apatinib, Fluzoparib Monotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Fluzoparib+ApatinibDrug

    Fluzoparib 100mg bid+ Apatinib 375mg qd

  • Fluzoparib MonotherapyDrug

    Fluzoparib 150mg bid

Study groups in NCT05479487
Study groupRoleWhat they receive
Fluzoparib+Apatinib combinationExperimentalNot described
Receives: Drug: Fluzoparib+Apatinib
Fluzoparib MonotherapyActive comparatorNot described
Receives: Drug: Fluzoparib Monotherapy

What is being measured

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

  1. Progression Free Survival (PFS) in previous PARP inhibitor treated relapsed ovarian cancer patients.

    To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined).

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Progression Free Survival (PFS) in relapsed ovarian patients

    To determine the efficacy by progression free survival (PFS) of the maintenance treatment in platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined).

    Measured: Up to 2 years

  2. Progression Free Survival (PFS) in BRCA1/2 mutated relapsed ovarian cancer patients.

    Measured: Up to 2 years

  3. Objective Response Rate (ORR)

    Measured: Up to 2 years

  4. Disease Control Rate (DCR）

    Measured: Up to 2 years

  5. Duration of Response (DoR)

    Measured: Up to 2 years

  6. Overall survival (OS）

    Measured: Up to 2 years

  7. Adverse Events (AEs)

    Assese the safety and tolerability of Fluzoparib combined with apatinib maintenance in platinum sensitive relapsed ovarian cancer patients by record the number of participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.

    Measured: From the first drug administration to within 30 days for the last treatment dose

Timeline

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

  1. First posted29 Jul 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Sep 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
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479487
Sponsor's protocol ID
MA-OC-II-005
Status last verified
Jul 2022
First submitted
25 Jul 2022
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data is available per require after approved by ethics broad

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib+Apatinib and Fluzoparib Monotherapy in people with Relapsed Ovarian Cancer, run by Xiaohua Wu MD.

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 19 inclusion and 19 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Xiaohua Wu, Ph.D., MD (+86 021-64175590, wu.xh@fudan.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) in previous PARP inhibitor treated relapsed ovarian cancer patients. (time frame: 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 NCT05479487.

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 29 Jul 2022.

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