RecruitingPhase 2NCT05872204

Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer

A Phase II, Open-label, Multicenter Study of Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

100 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the efficacy and safety of abemaciclib and letrozole for treatment of estrogen receptor-positive rare ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — abemaciclib (a CDK4/6 inhibitor that slows cancer cell division) and letrozole (a hormone-blocking drug) — in people with rare, oestrogen receptor-positive ovarian cancers that are difficult to treat with standard chemotherapy. **You may be eligible if...** - You have been diagnosed with a rare, oestrogen receptor-positive ovarian cancer (specific subtypes apply) - You have received at least one prior line of treatment - You are using highly effective contraception if you could become pregnant - Your organ function meets the required levels **You may NOT be eligible if...** - Your ovarian cancer is not of the eligible rare subtype - You are pregnant or planning to become pregnant during the study - You have certain cardiovascular conditions or other serious medical problems - You have not recovered from side effects of previous cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAbemaciclib

150 mg tablet twice daily

DRUGLetrozole

2.5 mg tablet once daily


Locations(12)

CHU de Liège

Liège, Liège, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Institut De Cancerologie Strasbourg Europe

Strasbourg, Bas-Rhin, France

Institut Bergonie

Bordeaux, Gironde, France

Institut Universitaire Du Cancer Toulouse-Oncopole

Toulouse, Haute-Garonne, France

Institut De Cancerologie De L'Ouest

Saint-Herblain, Loire-Atlantique, France

Centre Leon Berard

Lyon, Métropole de Lyon, France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, France

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Erasmus Medical Center Rotterdam

Rotterdam, South Holland, Netherlands

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05872204