RecruitingPhase 2NCT05113368

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Efficacy of Oral Regorafenib Combined With Intra-muscular Injection of Fulvestrant in Patients With Recurrent Low-grade Serous Ovarian Cancer: A Phase II Single Arm Trial


Sponsor

Sarah K. Lynam MD

Enrollment

31 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — regorafenib (a targeted cancer drug) and fulvestrant (a hormone-blocking drug) — in people with recurrent low-grade serous ovarian cancer. This type of ovarian cancer grows slowly but is often resistant to chemotherapy, and the trial explores whether blocking both tumor blood vessels and hormone signals might help. **You may be eligible if...** - You have recurrent low-grade serous ovarian cancer - Your cancer can be measured on scans (at least one measurable tumor) - You have had up to 5 prior lines of therapy - Prior hormone therapy (like letrozole) or MEK inhibitors are acceptable - You are 18 or older with a performance status of 0–2 - You are expected to live at least 12 weeks - Your blood counts and organ function are in an acceptable range **You may NOT be eligible if...** - You have received prior anti-angiogenesis therapy other than bevacizumab - You have significant uncontrolled high blood pressure or heart disease - You have had major surgery or serious bleeding within 4 weeks - You are pregnant or breastfeeding - You have certain uncontrolled infections or clotting disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRegorafenib

Oral regorafenib in a ReDOSplan (80 mg week#1, 120 mg week#2, 160 mg week#3 for cycle #1 then adjust final dose for subsequent cycles based on tolerance during cycle #1) \[3 weeks on/1 week off\] combined with intramuscular injection of fulvestrant 500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

DRUGFulvestrant

500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities


Locations(1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05113368


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