Fluzoparib Plus Famitinib Maintenance After First-Line Platinum Response in Advanced Ovarian Cancer
Fluzoparib Combined With Famitinib as Maintenance Therapy After Response to First-Line Platinum-Based Chemotherapy in Patients With Advanced Ovarian Cancer: A Single-Arm, Multicenter Clinical Study
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ying Zhou
- Phone Number: 051267972861
- Email: zhouying1989@suda.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Female patients aged 18 to 75 years at the time of informed consent. Newly diagnosed, histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, including high-grade serous or high-grade endometrioid carcinoma.
FIGO stage III-IV disease at initial diagnosis. Achieved complete response (CR) or partial response (PR) after completion of first-line platinum-based chemotherapy, with or without bevacizumab.
Initiation of study treatment within 9 weeks after the last dose of platinum-based chemotherapy.
ECOG performance status 0-1. Adequate bone marrow, liver, and renal function, as defined by protocol-specified laboratory criteria.
Life expectancy of ≥12 weeks. Ability to swallow oral medications and comply with study requirements. Signed written informed consent prior to any study-specific procedures.
Exclusion Criteria:
Evidence of disease progression during or after first-line platinum-based chemotherapy.
Prior treatment with any PARP inhibitor or anti-angiogenic tyrosine kinase inhibitor (except bevacizumab as part of first-line therapy).
Prior systemic anti-cancer therapy for ovarian cancer other than first-line platinum-based chemotherapy.
Uncontrolled or significant cardiovascular disease, including but not limited to uncontrolled hypertension, recent myocardial infarction, or clinically significant arrhythmia.
Active or uncontrolled infection, or serious concomitant systemic disorders that may interfere with study participation.
Known central nervous system metastases. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer.
Pregnant or breastfeeding women. Known hypersensitivity to fluzoparib, famitinib, or any of their excipients. Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maintenance Therapy: Fluzoparib + Famitinib
Patients who achieved complete or partial response after first-line platinum-based chemotherapy receive maintenance therapy with fluzoparib plus famitinib malate.
Fluzoparib is administered orally at 150 mg twice daily, and famitinib malate is administered orally at 10 mg once daily in 28-day cycles, continued until disease progression, unacceptable toxicity, withdrawal of consent, or completion of up to 24 cycles.
|
Fluzoparib is administered orally at a dose of 150 mg twice daily, and famitinib malate is administered orally at a dose of 10 mg once daily.
Treatment is given in 28-day cycles as maintenance therapy following complete or partial response to first-line platinum-based chemotherapy, and is continued until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or completion of up to 24 cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS)
Time Frame: From treatment initiation up to approximately 48 months
|
Progression-free survival is defined as the time from initiation of maintenance treatment with fluzoparib plus famitinib to the first documentation of disease progression according to RECIST v1.1 criteria or death from any cause, whichever occurs first.
|
From treatment initiation up to approximately 48 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- fluzoparib
- famitinib
Other Study ID Numbers
- 2026091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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