NCT05113368

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Sarah K. Lynam MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Regorafenib is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells by stopping the signals that tell the cancer cells to grow and the ability of the cancer cells to form new blood vessels which they need to be able to grow. Treatment will continue until disease progression or unacceptable toxicities. For participants with a complete response to therapy, maintenance therapy with both drugs will be continued for 12 months.

Conditions

• Ovarian Cancer
• Serous Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	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
DRUG	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

Timeline

• Start date: 2022-06-28
• Primary completion: 2026-09-01
• Completion: 2027-02-01
• First posted: 2021-11-09
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study