Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi

NCT06161272 | Unknown Phase 2 DMC

• 1 other identifier: CS2023(166)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib.

Conditions

Ovarian Cancer; High Grade Serous Adenocarcinoma of Ovary; Primary Peritoneal Carcinoma; Fallopian Tube Cancer

Keywords

ovarian cancer; PARP inhibitors; Flzuoparib; Antiangiogenic agents; Apatinib

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first.

  from the randomization up to 2 years

Secondary Outcomes (7)

• Overall survival (OS)

  from the randomization up to 3 years

• Objective Response Rate (ORR)

  from the randomization up to two years

• Disease control rate (DCR)

  from the randomization up to two years

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

  from the randomization up to 3 years

• Time to start of second subsequent therapy or death (TSST)

  from the randomization up to 3 years

Study Arms (2)

Arm1：Fluzoparib

EXPERIMENTAL

Fluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle.

Drug: Fluzoparib

Arm2：Fluzoparib + apatinib

EXPERIMENTAL

Fluzoparib capsule: oral administration, 2 capsules/dose (100 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle. Apatinib: oral administration, 1 tablet/dose (375 mg/tablet), once a day, it is recommended to take orally within 0.5h after breakfast, continuous administration. Every 4 weeks is a treatment cycle.

Drug: Fluzoparib+Apatinib

Interventions

Fluzoparib DRUG

single

Arm1：Fluzoparib

Fluzoparib+Apatinib DRUG

combination

Arm2：Fluzoparib + apatinib

Eligibility Criteria

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

You may qualify if:

• The patient voluntarily joined the study and signed the informed consent.
• Female, 18-75 years (calculated on date of signing informed consent).
• Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
• \- Mixed tumors: contain high-grade serous component or endometrioid components over 50%.
• Disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy.
• Prior treatment with ≥2 platinum-containing chemotherapy regimens and disease remission (complete or partial response) at the end of the last platinum chemotherapy, which lasted until study administration, must be randomized to enrollment and start trial drug administration within 8 weeks from the last chemotherapy administration.
• Preoperative neoadjuvant chemotherapy and postoperative chemotherapy counted as 1 chemotherapy treatment regimen.
• The last chemotherapy must be a platinum-based chemotherapy regimen.
• Patient must have received at least 4 cycles of treatment for the last platinum-based chemotherapy, during or after platinum-containing chemotherapy, concurrent use of other investigational drugs and treatment other than endocrine therapy drugs are not permitted.
• A detectable lesion or CA-125 ≥2 ×ULN is required before the last platinum treatment.
• The imaging results showed CR or PR during the last platinum-containing regimen, CA125 decreased to within the ULN or ≥90% from pre-treatment level during treatment and CA125 remained \<1xULN or did not increase by \>10% in 7 days before the first treatment.
• If no lesion is assessed prior to chemotherapy, CA125 should be alleviated to the ULN during treatment and maintained at \<1xULN for 7 days prior to the first treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The duration of continuous PARPi treatment during the previous maintenance treatment period was ≥6 months.
• Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted)

You may not qualify if:

• Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry; Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix or breast cancer without recurrence over 3 years allowed.
• The expected survival is less than three months.
• Participants with untreated central nervous system metastases
• \- patients who had previously received systemic, radical brain or meninges metastases (radiotherapy or surgery), had been stable for at least 1 month on imaging, had stopped systemic sex hormone therapy (dose \>10mg/ day or other therapeutic hormones) for more than 2 weeks, and had no clinical evidence could be included.
• Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.
• Intestinal obstruction within 3 months.
• The urine protein ≥ ++ and 24-hour urine protein level \> 1.0g.
• Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
• Uncontrolled heart clinical symptoms or diseases, such as :(1) NYHA 2 or more heart failure, (2) Unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Ventricular arrhythmias requiring intervention, (5) QTc\>470ms.
• Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds), bleeding tendency or receiving thrombolytic therapy are allowed to receive low-dose low-molecular weight heparin or oral aspirin preventive anticoagulant therapy during the study.
• Significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc., within the first 3 months of the randomization. If fecal occultation blood is positive at baseline, gastroscopy should be performed if still positive after reexamination.
• Active ulcers, unhealed wounds or fractures.
• Uncontrolled hypertension by antihypertensive medication (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg).
• Any bleeding event with grade 2 or higher in CTCAE 5.0 within 4 weeks prior randomization.
• Active infection or unexplained fever \>38.5 degrees during screening or before first treatment.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Affiliated Tumor Hospital of Guangxi Medical University.

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube 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; Fallopian Tube Diseases

Central Study Contacts

Li Li

CONTACT

13878113406; lili@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: December 10, 2023
• Primary Completion: March 10, 2025
• Study Completion: January 10, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

CN (1)