Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer

Sponsor
Anhui Provincial Hospital
Study ID
NCT06539091
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.
  • Apatinib Mesylate — DRUG
    The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are also required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.

Study Details

This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer. Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate. The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.

Key Dates

Start date
Oct 1, 2024
Status verified
Jul 2024
Primary completion
Oct 1, 2025
Completion
Oct 1, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib group
    During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment.
  • Experimental: Apatinib Mesylate group
    During the treatment period, subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment.

Primary Outcome Measure

PFS [ Time Frame: 2 year ]

Central Contacts

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