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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Sarah K. Lynam MD
Study ID
NCT05113368
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 28, 2022
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Regorafenib combined with intra-muscular injection of Fulvestrant
    Oral regorafenib in a ReDOS plan (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

Primary Outcome Measure

Complete Response Rate of the Drug Regimen [ Time Frame: 12 weeks from first cycle of treatment (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Sarah M Lynam, MD
[email protected]
800-641-2422

Find similar trials in Cleveland, OH

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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