Ongoing Clinical Trials for Ovarian Granulosa Cell Tumour
There is currently 1 ongoing clinical trial for ovarian granulosa cell tumour, specifically focusing on the adult-type variant of this rare cancer. This trial is testing a combination treatment approach using two medications that target hormone-sensitive cancer cells, and is being conducted across multiple European countries.
Clinical trial locations
- Belgium
- France
- Netherlands
Study of Abemaciclib and Letrozole for Patients with Estrogen Receptor Positive Low-Grade Serous Ovarian Cancer and Adult-Type Granulosa Cell Tumor
This trial is investigating a combination of two medications for treating rare types of ovarian cancer, including adult-type granulosa cell tumor. The study tests whether abemaciclib and letrozole work well together to slow or stop the growth of these cancers.
Main inclusion criteria:
- Adults over 18 years old who can provide written informed consent
- Confirmed diagnosis of adult-type granulosa cell tumor that shows estrogen receptor positivity
- At least one tumor that can be measured using imaging tests like CT or MRI
- Previous treatment with at least one round of platinum-based chemotherapy for advanced or returning disease
- Good overall health, with an ECOG performance status of 0-1, meaning patients can perform most daily activities with little or no restrictions
- Adequate blood counts and organ function based on laboratory tests
- Non-functioning ovaries, or willingness to undergo hormonal suppression
- Women with at least one ovary must use highly effective birth control methods during the study
- Willingness to provide tissue biopsies and blood samples for research purposes
Main exclusion criteria:
- Male patients cannot participate
- Patients who do not have the specific types of cancer being studied
- Patients outside the specified age range
- Vulnerable populations as defined by the study protocol
Focus and goal: The trial aims to understand how well the combination of abemaciclib and letrozole works in treating these specific rare ovarian cancers. The study will monitor participants closely through regular check-ups, imaging studies, and laboratory tests to assess how the cancer responds to treatment. Participants will join the study after providing written consent, undergo initial assessments to confirm eligibility, and then begin oral treatment with both medications. Throughout the treatment period, the research team will collect tissue biopsies and blood samples to better understand how the medications work. The main goal is to determine the overall response rate, which means measuring how well the cancer responds to this combination treatment. This information could help develop future treatment options for these rare cancers.
Investigational drugs: The trial uses abemaciclib, a medication that blocks certain proteins called cyclin-dependent kinases 4 and 6, which cancer cells need to divide and grow. By blocking these proteins, abemaciclib may slow down or stop the progression of cancer. The second medication is letrozole, which belongs to a class of drugs called aromatase inhibitors. Letrozole works by reducing estrogen levels in the body, which can help slow or stop the growth of cancer cells that need estrogen to grow. Both medications are taken orally as tablets.
Summary
Currently, there is one active clinical trial available for patients with ovarian granulosa cell tumour, specifically targeting the adult-type variant. This trial is being conducted in three European countries: Belgium, France, and the Netherlands, providing patients in these regions with access to this investigational treatment.
The trial focuses on a targeted treatment approach using a combination of two medications that work in different ways to combat hormone-sensitive cancer cells. Abemaciclib targets cell division mechanisms, while letrozole reduces hormone levels that may fuel cancer growth. This dual approach represents an innovative strategy for treating this rare type of ovarian cancer.
Patients interested in participating should note that the trial requires previous treatment with platinum-based chemotherapy and confirmation that the tumor expresses estrogen receptors. The study is designed for patients who maintain good overall health and can perform most daily activities with minimal restrictions.