Study on Regorafenib and Fulvestrant for Recurrent Low-Grade Serous Ovarian Cancer

Sponsor: Sarah K. Lynam MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05113368

Provider View

This clinical trial is testing a combination of the study drug Regorafenib and hormone therapy Fulvestrant to see if it can effectively treat patients with recurrent low-grade serous ovarian cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of Regorafenib, an investigational drug, and Fulvestrant, a hormone therapy, works in treating patients with recurrent low-grade serous ovarian cancer. Regorafenib works by blocking signals that cause cancer cells to grow and form new blood vessels. Treatment will continue until the cancer progresses or side effects become unacceptable. If patients respond completely to the therapy, they will continue maintenance treatment with both drugs for 12 months.

Description

Regorafenib is a study drug that aims to stop cancer cells from growing and forming new blood vessels, which they need to grow. This study is testing Regorafenib in combination with Fulvestrant, a hormone therapy, to see if it can help treat recurrent low-grade serous ovarian cancer. Patients will continue treatment until their cancer progresses or they experience unacceptable side effects. If a patient has a complete response to the therapy, they will continue maintenance treatment with both drugs for 12 months.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent low-grade serous ovarian cancer.
  • Have had up to 5 previous treatments.
  • Previous treatment with MEK inhibitors and aromatase inhibitors like letrozole is allowed.
  • Previous treatment with anti-angiogenesis therapy is not allowed, except for bevacizumab.
  • Must have measurable cancer based on specific criteria and available tumor tissue.
  • Must have a performance status score of 0-2, indicating full activity or some restriction in strenuous activities.
  • Be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Must understand and agree to sign a consent form.
  • Have adequate bone marrow, liver, and kidney function based on specific lab tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception during and for 2 months after the study.
  • Must be able to swallow and retain oral medication.
  • Must provide a tumor tissue sample from a previous diagnosis or recurrence.

Exclusion Criteria

  • Have sarcoma, carcinosarcoma, or high-grade carcinoma.
  • Have a cancer type other than low-grade serous ovarian cancer.
  • Have been previously treated in this study.
  • Have uncontrolled high blood pressure despite treatment.
  • Have significant heart disease or recent heart attack.
  • Have a history of bleeding disorders or recent severe bleeding.
  • Have had recent blood clots or strokes.
  • Have another untreated or active cancer, except for certain non-threatening types.
  • Have a history of certain infections or untreated infections.
  • Have brain tumors causing symptoms.
  • Have non-healing wounds or recent major surgery.
  • Have kidney failure requiring dialysis.
  • Have certain lung diseases or fluid buildup causing breathing problems.
  • Have had an organ transplant or allergies to study drugs.
  • Have gastrointestinal issues preventing oral medication.
  • Be pregnant or breastfeeding.
  • Have any condition making participation unsuitable.
  • Have substance abuse or other conditions affecting participation.
  • Be receiving other cancer treatments outside of the study.
  • Have used Regorafenib or similar drugs before.
  • Be using another investigational drug or device.
  • Be on certain blood thinners without careful monitoring.
  • Be using herbal remedies like St. John's wort.

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