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

NCT05170594 | Unknown Phase 2 DMC

• 1 other identifier: MT-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

platinum-resistant; recurrent ovarian cancer; Bevacizumab; Fluzoparib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective remission rate

  2 years

• Overall Survival

  2 years

• Adverse event Adverse event

  2 years

Study Arms (3)

Bevacizumab combined with Fluzoparib

EXPERIMENTAL

Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.

Drug: Bevacizumab; Drug: chemotherapy

Bevacizumab combined with chemotherapy

EXPERIMENTAL

Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.

Drug: Bevacizumab; Drug: chemotherapy

Fluzoparib

EXPERIMENTAL

Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.

Drug: Fluzoparib

Interventions

Bevacizumab DRUG

Bevacizumab will be administered at 15mg/kg IV, every 3 weeks

Also known as: Antiangiogenic drugs

Bevacizumab combined with Fluzoparib; Bevacizumab combined with chemotherapy

chemotherapy DRUG

The non-platinum chemotherapy regimen will be determined by the investigator.

Also known as: Non-platinum chemotherapy

Bevacizumab combined with Fluzoparib; Bevacizumab combined with chemotherapy

Fluzoparib DRUG

Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable

Also known as: PARPi

Fluzoparib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 26723501 BACKGROUND

• 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.

  PMID: 30948273 BACKGROUND

• 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.

  PMID: 34711457 BACKGROUND

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Drug Therapy; fluzoparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Haiyan Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Miao

CONTACT

+86-13854893531; miaoyue0626@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 28, 2021
• Study Start: December 24, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)