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Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment

ConditionRelapsed Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaohua Wu MD

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluzoparib+Apatinib

    Drug

    Fluzoparib 100mg bid+ Apatinib 375mg qd

  • Fluzoparib Monotherapy

    Drug

    Fluzoparib 150mg bid

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Fluzoparib+Apatinib combinationExperimental treatment 1 intervention
Group B: Fluzoparib MonotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
Up to 2 years

Secondary outcomes

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).

Time frame
Up to 2 years
2

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

Time frame
Up to 2 years
3

Objective Response Rate (ORR)

Time frame
Up to 2 years
4

Disease Control Rate (DCR）

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaohua Wu MD

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: