Spots Global Cancer Trial Database for Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
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Trial Identification
Brief Title: Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
Official Title: A Phase II, Open-label, Multicenter Study of Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
Study ID: NCT05872204
Study Description
Brief 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.
Detailed Description: Patients with recurrent, persistent and/or metastatic estrogen receptor-positive rare ovarian cancer, who failed one line of platinum based chemotherapy for advanced or recurrent disease, will be included in this study. One cohort will include low-grade serous or endometrioid epithelial ovarian cancer and another cohort will include adult type granulosa cell tumors. The results of large randomized phase 3 trials of the combination of an aromatase inhibitor combined with a CDK4/6 inhibitor in hormone sensitive, HER2 negative breast cancer can form the basis for a trial with this drug combination in hormone sensitive rare ovarian cancer. The aim is to increase the response rate to aromatase inhibitors and the duration of response in this study population with limited therapeutic options, monitor the quality of life and explore the (epi)genomic signatures that correlate with response or endocrine resistance. Abemaciclib will be supplied as capsules administered orally, 150 mg every 12 hours (Q12H) on Days 1 to 28 of a 28-day cycle, plus letrozole 2.5 mg OD Days 1 to 28 of a 28-day cycle.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UZ Gent, Gent, Oost-Vlaanderen, Belgium
UZ Leuven, Leuven, Vlaams-Brabant, Belgium
CHU de Liège, Liège, , 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, France
Erasmus Medical Center Rotterdam, Rotterdam, South Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Contact Details
Name: Els Van Nieuwenhuysen, MD PhD
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR
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