Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

NCT06552858 | Not Yet Recruiting Phase 2

• 1 other identifier: FD-OCR-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; platinum resistance; Fluzoparib; Dalpiciclib

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  Two years

Secondary Outcomes (2)

• OS

  Two years

• ORR

  Two years

Study Arms (1)

Fluzoparib with Dalpiciclib

EXPERIMENTAL

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

Drug: Fluzoparib; Drug: Dalpiciclib

Interventions

Fluzoparib DRUG

150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair.

Fluzoparib with Dalpiciclib

Dalpiciclib DRUG

150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis.

Fluzoparib with Dalpiciclib

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib; dalpiciclib

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

Xingzhu Ju, MD

CONTACT

+86 18601684480; a610278155@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Oncology

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)