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Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

ConditionRelapsed Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJin Li

About this trial

This study is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient voluntarily joined the study and signed the informed consent.

Age 18-75 years old.

Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.

Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.

Disqualifiers

Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery.

The subject has untreated central nervous system metastasis.

Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.

Recent (within 3 months) occurrence of intestinal obstruction.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluzoparib

    Drug

    Fluzoparib 100mg bid

  • Apatinib

    Drug

    Apatinib 375mg qd

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Fluzoparib+Apatinib combinationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival(PFS)

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

Objective Response Rate (ORR)

Time frame
Up to 2 years
2

Disease Control Rate (DCR）

Time frame
Up to 2 years
3

Overall survival (OS）

Time frame
Up to 2 years
4

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.

Time frame
From the first drug administration to within 30 days for the last treatment dose

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Jin Li

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

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