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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170594
• Other study ID #: MT-004
• Status: Recruiting
• Phase: Phase 2
• Start date: December 24, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2021
• Source: The Second Affiliated Hospital of Shandong First Medical University
• Contact: Yue Miao
• Phone: +86-13854893531
• Email: miaoyue0626[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab will be administered at 15mg/kg IV, every 3 weeks
• chemotherapy
The non-platinum chemotherapy regimen will be determined by the investigator.
• Fluzoparib
Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Shandong First Medical University	Tai'an	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Shandong First Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña 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. — View 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. Review. — View 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. Erratum in: Lancet Oncol. 2019 May;20(5):e242. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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).	2 years
Secondary	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)	2 years
Secondary	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	2 years