Status unknownNCT05170594Updated Dec 28, 2021

A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer

A Phase 2 interventional study of Bevacizumab and chemotherapy in Ovarian Cancer, sponsored by The Second Affiliated Hospital of Shandong First Medical University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-28.

Sponsored by The Second Affiliated Hospital of Shandong First Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Female

Study summary

This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.

Read the detailed description

This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.

Conditions studied

Ovarian Cancer

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Keywords

platinum-resistant
recurrent ovarian cancer
Bevacizumab
Fluzoparib

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

The Second Affiliated Hospital of Shandong First Medical University is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Age ≥18 years, female;
Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
ECOG score was 0-1;
Expected survival time > 12 weeks;
Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
Patients not previously treated with PARPi or targeted drugs;
The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months;
The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

Known allergy to fluzopalil or study drug components;
Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
Pregnant or lactating women or subjects who cannot use contraception as required;
Those who have special requirements on diet and cannot accept uniform diet;
As judged by the researcher, there are other circumstances that are not suitable for the researcher.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Bevacizumab combined with Fluzoparib
Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.
Drug: Bevacizumab · Drug: chemotherapy
Experimental
Bevacizumab combined with chemotherapy
Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Drug: Bevacizumab · Drug: chemotherapy
Experimental
Fluzoparib
Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Drug: Fluzoparib

Interventions

DrugBevacizumab
Bevacizumab will be administered at 15mg/kg IV, every 3 weeks
Also known as: Antiangiogenic drugs
Drugchemotherapy
The non-platinum chemotherapy regimen will be determined by the investigator.
Also known as: Non-platinum chemotherapy
DrugFluzoparib
Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable
Also known as: PARPi

What researchers measure

Primary outcomes

Progression-Free-Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Time frame: 2 years

Secondary outcomes

Objective remission rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR).
Time frame: 2 years
Overall Survival
Time from randomization to death from any cause (for subjects who have been lost to follow-up prior to death, the time of death is usually calculated as the time of last follow-up)
Time frame: 2 years
Adverse event Adverse event
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
Time frame: 2 years

Study locations

1 of 1 sites recruiting

The Second Affiliated Hospital of Shandong First Medical University
Tai'an, Shandong 271000, China
- Zhensheng Fang · Contact · sdtatszhenhua@126.com · +86-0538-6236830
- Haiyan Liu · Principal investigator
Recruiting

References and documents

Publications

Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23. PubMed 26723501 ↗
Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1. Erratum In: Lancet Oncol. 2019 May;20(5):e242. doi: 10.1016/S1470-2045(19)30242-6. PubMed 30948273 ↗
Mellinghoff IK, Chang SM, Jaeckle KA, van den Bent M. Isocitrate Dehydrogenase Mutant Grade II and III Glial Neoplasms. Hematol Oncol Clin North Am. 2022 Feb;36(1):95-111. doi: 10.1016/j.hoc.2021.08.008. Epub 2021 Oct 25. PubMed 34711457 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05170594
Lead sponsor: The Second Affiliated Hospital of Shandong First Medical University
Responsible party: Sponsor
First posted: Dec 28, 2021
Start date: Dec 24, 2021
Primary completion: Jun 30, 2024 (estimated)
Completion: Jun 30, 2024 (estimated)
Last update: Dec 28, 2021

Study contacts

Yue Miao

Contact

miaoyue0626@126.com

+86-13854893531

Haiyan Liu

principal investigator · The Second Affiliated Hospital of Shandong First Medical University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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