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

NCT05113368 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-08-21

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Sarah K. Lynam MD

    lead OTHER

Principal Investigators

  • Sarah Lynam, MD · Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2026-09-30
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113368 on ClinicalTrials.gov