A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT05585281 | Unknown Phase 2

• 1 other identifier: 20220501
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival(PFS)

  PFS by investigator's assessment

  up to 2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  up to 2 years

• Second Progression Free Survival（PFS2）

  up to 2 years

• Time to start of first subsequent therapy or death（TFST）

  up to 2 years

• Health-related quality of life（HRQoL）

  up to week 24

Study Arms (1)

Participants receiving Fluzoparib+ QL1101

EXPERIMENTAL

Participants will be administered QL1101 7.5 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Fluzoparib will be administered orally twice daily continuously throughout each 21-day cycle. On Day 1 of each cycle, fluzoparib will be administered upon completion of QL1101 infusion. The starting dose of fluzoparib will be based on the participant's Baseline actual body weight or platelet count.

Drug: Fluzoparib; Biological: QL1101

Interventions

Fluzoparib DRUG

Fluzoparib Orally twice daily

Participants receiving Fluzoparib+ QL1101

QL1101 BIOLOGICAL

Maintenance QL1101 7.5 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. QL1101 will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of QL1101 received with chemotherapy.

Participants receiving Fluzoparib+ QL1101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I-1.Patients voluntarily participated in this study and signed the informed consent.
• I-2.Age 18-70 years, female. I-3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-4.Patients with newly diagnosed, histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer（FIGO Stage III or IV）.
• I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initial cytoreduction).
• I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6 treatment cycles and a maximum of 8 treatment cycles in patients who have achieved complete response (CR) or partial response (PR).
• I-7.Patients who must receive at least 4 cycles of platinum-based therapy if non-hematologic toxicity specifically associated with platinum-based therapy (i.e., neurotoxicity, hypersensitivity reactions, etc.) necessitates early termination.
• I-8.Those who can swallow tablets normally.
• I-9.The functions of vital organs meet the following requirements:
• Absolute neutrophil count ≥ 1.5 × 109/L;
• Platelets ≥ 90 × 109/L;
• Hemoglobin ≥ 100 g/L;
• Serum albumin ≥ 30 g/L;
• Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN);
• ALT and AST ≤ 3 × ULN; in case of liver metastases, ALT and AST \< 5 × ULN;
• Serum creatinine ≤ 1.5 × ULN;
• International normalized ratio (INR) ≤1.5 and activated prothrombin time (aptt) ≤1.5× ULN in patients not receiving anticoagulants.

You may not qualify if:

• E-1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
• E-2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
• E-3.Clinical evidence of stable disease or progressive disease following treatment at the end of the first-line chemotherapy.
• E-4.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)Patients with a history of localized malignancy diagnosed over 5 years ago, who have completed all treatment and have no recurrent or metastatic disease prior to enrollment may be enrolled.
• E-5.Patients with myelodysplastic syndrome/acute myeloid leukemia history. E-6.Patients receiving radiotherapy within 6 weeks or Major surgery within 4 weeks prior to study treatment.
• E-7.Any previous treatment with PARP inhibitor, including fluzoparib. E-8.Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
• E-9.Clinically significant (e.g. active) cardiovascular disease, including:
• New York Heart Association (NYHA) grade 2 or higher heart failure.
• Unstable angina pectoris.
• Myocardial infarction within 1 year.
• Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
• Qtc\>470ms. E-10.Patients who underwent cytoreductive surgery more than once before maintenance treatment（Patients who were considered unresectable at diagnosis only received biopsy or ovarian resection, and then continued chemotherapy for intermediate cytoreductive surgery may be enrolled）.
• E-11.Patients who have received chemotherapy for abdominal or pelvic tumors, including those who received chemotherapy for early diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• E-12.Patients with synchronous primary endometrial cancer unless both of the following two criteria are met:
• Sage \< 2.

Sponsors & Collaborators

• Yongpeng Wang: lead

Study Sites (1)

Yongpeng Wang

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

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

Central Study Contacts

Yongpeng Wang

CONTACT

+8613940426817; w18900917191@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: July 27, 2023
• Primary Completion: November 7, 2025
• Study Completion: December 22, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CN (1)