Sarah K. Lynam MD
To see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.
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.
Inclusion Criteria: * Subjects must have recurrent low-grade serous ovarian cancer. * Up to 5 prior lines of therapy are allowed. * Prior therapy with MEK inhibitors is allowed * Prior therapy with aromatase inhibitors like letrozole is allowed * Prior anti-angiogenesis therapy is not allowed except for bevacizumab. * Subjects must have measurable disease based on RECIST 1.1 with at least one target lesion and with available archival tumor tissue. * Subjects must have an ECOG performance status of 0-2. * Age ≥ 18 years. * Life expectancy of at least 12 weeks (3 months). * Subjects must be abl…
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
500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities
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