RecruitingRare disease

Study of Abemaciclib and Letrozole for Patients with Estrogen Receptor Positive Low-Grade Serous Ovarian Cancer and Adult-Type Granulosa Cell Tumor

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of rare ovarian cancer: low-grade serous ovarian cancer and adult-type granulosa cell tumor. The study will use a combination of two medications, abemaciclib and letrozole. Abemaciclib is a type of medication that helps to block certain proteins that cancer cells need to grow, while letrozole is a medication that reduces estrogen levels, which can help slow the growth of certain types of cancer cells.

The purpose of the study is to determine how well the combination of abemaciclib and letrozole works in treating these specific types of ovarian cancer. Participants in the study will take these medications in the form of tablets. The study will involve regular check-ups and monitoring to assess the response to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study will last for a period of time, during which participants will be closely monitored for any changes in their condition. The goal is to understand the overall response rate to the treatment, which means how well the cancer responds to the combination of medications. This information will help in understanding the effectiveness of the treatment and may contribute to future treatment options for these rare types of ovarian cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will provide written consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes evaluating the disease using imaging techniques like CT or MRI to ensure measurable disease is present.
Step 3
Treatment initiation
The treatment involves taking two medications: abemaciclib and letrozole. Both medications are administered orally.
The specific dosage and frequency will be determined by the study protocol and communicated to the participant by the healthcare team.
Step 4
Ongoing treatment and monitoring
Participants will continue to take the medications as prescribed. Regular monitoring will occur to assess the response to treatment and any side effects.
Monitoring includes clinical evaluations, laboratory tests, and imaging studies to track the progress of the disease.
Step 5
Biopsy and blood samples
Pre- and post-treatment tissue biopsies and blood samples will be collected. These are necessary for additional studies related to the trial.
Step 6
Completion of treatment
The treatment phase will continue until the study's end date or until the participant's healthcare team decides to stop treatment based on the participant's health status.
Step 7
Follow-up
After completing the treatment, follow-up visits will be scheduled to monitor the participant's health and any long-term effects of the treatment.

Who can join the trial?

13 criteria

The participant must provide voluntary written informed consent before any screening procedures begin. This means they agree to join the study after understanding what it involves.
The participant should have an ECOG performance status of 0-1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
The participant must have a disease that can be measured and evaluated. This means having at least one tumor that can be accurately measured using imaging tests like CT or MRI, or by physical examination.
The participant must agree to provide tissue samples from a biopsy and blood samples for research purposes.
Women with at least one ovary must use highly effective birth control methods to prevent pregnancy during the study.
Participants who have been treated with letrozole or similar medications before are allowed, but only up to 10 such participants in each group. However, if their disease got worse while on these medications, they cannot join the study.
Participants who had radiotherapy must have finished the treatment and recovered from its immediate effects. There should be at least 14 days between the end of radiotherapy and joining the study.
Participants should not have functioning ovaries. If they do, menopause must be confirmed through lab tests, or they must undergo hormonal suppression or a procedure to stop ovarian function.
Participants can have abnormal organ function, but they must meet certain blood test criteria, such as having enough white blood cells, platelets, and hemoglobin, and normal levels of kidney and liver function tests.
The participant must have a confirmed diagnosis of specific types of ovarian cancer or granulosa-cell tumor, and the cancer must show ER positivity, meaning it has estrogen receptors, as determined by a pathologist.
Participants must have received at least one round of platinum-based chemotherapy for advanced or returning disease.
For Stage 1, participants must be eligible for platinum treatment with a gap of at least 6 months since the last treatment. For Stage 2, similar criteria apply, but up to 10 participants who cannot have platinum treatment are allowed.
The participant must be over 18 years old at the time of joining the study.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate.
Patients who do not have **low-grade serous ovarian cancer** or **adult-type granulosa cell tumor** cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Katholieke Universiteit te Leuven
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Leuven, Belgium
Universitair Medisch Centrum Utrecht
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Utrecht, The Netherlands

Trial locations

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Investigated drugs

Abemaciclib
is a medication used in this trial to help treat certain types of cancer. It works by blocking proteins that promote the growth of cancer cells, potentially slowing down or stopping the progression of the disease.
Letrozole
is another medication involved in the trial. It is used to treat hormone receptor-positive cancers by lowering estrogen levels in the body, which can help slow or stop the growth of cancer cells that need estrogen to grow.

What is already known about the treatment

Abemaciclib
Abemaciclib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating certain types of ovarian cancer, specifically low-grade serous ovarian cancer and adult-type granulosa cell tumor. The medication works by inhibiting proteins known as cyclin-dependent kinases 4 and 6, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a targeted cancer therapy.
Letrozole
Letrozole is taken orally as a tablet. It is widely used in the treatment of hormone receptor-positive breast cancer and is now being explored in clinical trials for its potential benefits in rare ovarian cancers, such as low-grade serous ovarian cancer and adult-type granulosa cell tumor. Letrozole functions by reducing estrogen levels in the body, which can help slow or stop the growth of certain types of cancer cells that require estrogen to grow. It belongs to a class of drugs known as aromatase inhibitors.

Investigated diseases

Low-grade serous ovarian cancer
This is a type of ovarian cancer characterized by slow-growing tumors that originate from the surface of the ovary. It is less aggressive compared to other forms of ovarian cancer and often affects younger women. The disease typically presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. Over time, the cancer may spread to nearby tissues and organs within the pelvis and abdomen. It is known for its resistance to conventional chemotherapy, making management challenging. The progression is generally slower, but it requires careful monitoring and management.
Adult-type granulosa cell tumor
This is a rare form of ovarian tumor that arises from the sex-cord stromal cells of the ovary. It is known for its potential to produce hormones, particularly estrogen, which can lead to symptoms like abnormal uterine bleeding or menstrual irregularities. The tumor is typically slow-growing and may not cause symptoms until it reaches a significant size. It can sometimes be detected during routine pelvic examinations or imaging studies. Although it is generally considered less aggressive, it can recur many years after initial treatment. The disease requires long-term follow-up due to its potential for late recurrence.