Clinical trial NCT05170594: A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer
Official title: A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: platinum-resistant
recurrent ovarian cancer
Bevacizumab
Fluzoparib
Lead sponsor: The Second Affiliated Hospital of Shandong First Medical University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years, female;
2. Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
3. ECOG score was 0-1;
4. Expected survival time \> 12 weeks;
5. 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;
6. Patients not previously treated with PARPi or targeted drugs;
7. 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;
8. 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:

1. Known allergy to fluzopalil or study drug components;
2. 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);
3. 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;
4. 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;
5. Pregnant or lactating women or subjects who cannot use contraception as required;
6. Those who have special requirements on diet and cannot accept uniform diet;
7. As judged by the researcher, there are other circumstances that are not suitable for the researcher.

Primary outcomes:
measure: Progression-Free-Survival
timeFrame: 2 years
Secondary outcomes:
measure: Objective remission rate
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Adverse event Adverse event
timeFrame: 2 years
Other outcomes:
Locations:
city: Tai'an
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: The Second Affiliated Hospital of Shandong First Medical University
name: Haiyan Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.