Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

Phase 2

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Fluzoparib; Drug: Dalpiciclib

• Registration Number: NCT06552858
• Lead Sponsor: Fudan University

Brief Summary

This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.

Detailed Description

1. Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.

2. Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.

3. Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.

4. Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Age≥18 years old;
2. Sign the informed consent form;
3. Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
4. Tumor recurrence or progression within 6 months after using platinum-based drugs;

Exclusion Criteria

1. Any uncontrolled medical condition that may put the patient at high risk during treatment .
2. Receipt of any other investigational medicinal product within the last 30 days before randomization.
3. Patients with ovarian cancer excluded by pathological or clinical diagnosis;
4. Physical intolerance patients;
5. Patients who are unwilling to participate in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluzoparib with Dalpiciclib	Fluzoparib	Oral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance.
Fluzoparib with Dalpiciclib	Dalpiciclib	Oral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance.

Primary Outcome Measures

Name	Time	Method
PFS	Two years	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	Two years	Overall Survival
ORR	Two years	Overall Remission Rate

Trial Locations

Locations (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology; 🇨🇳 Shanghai, Shanghai, China