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

NCT06539091 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Epithelial Ovarian Cancer
  • Efficacy
  • Safety
  • Bone Mineral Density
  • Tolerability

Interventions

DRUG

Fluzoparib

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.

DRUG

Apatinib Mesylate

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.

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Ying Zhou, MD · The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-10-01
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539091 on ClinicalTrials.gov