Universitaire Ziekenhuizen KU Leuven
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.
Low Grade Serous Ovarian Carcinoma
Adult Type Granulosa Cell Tumor
Abemaciclib
Letrozole
Phase 2
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.
Study Type : | Interventional |
Estimated Enrollment : | 100 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-label, Multicenter Study of Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer |
Actual Study Start Date : | November 30, 2023 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | October 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Abemaciclib and letrozole Participants received abemaciclib 150 mg tablet orally twice daily and letrozole tablet 2.5 mg orally once daily until disease progression, unacceptable adverse event(s) or death. |
Drug: Abemaciclib Drug: Letrozole |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
UZ Gent
Gent, Oost-Vlaanderen, Belgium, 9000
Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Recruiting
CHU de Liège
Liège, Bas-Rhin, Belgium, 4000
Not yet recruiting
Institut De Cancerologie Strasbourg Europe
Strasbourg, Gironde, France, 67200
Not yet recruiting
Institut Bergonie
Bordeaux, Haute-Garonne, France, 33000
Not yet recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
Toulouse, Loire-Atlantique, France, 31059
Not yet recruiting
Institut De Cancerologie De L'Ouest
Saint-Herblain, Métropole De Lyon, France, 44800
Not yet recruiting
Centre Leon Berard
Lyon, Île-de-France, France, 69008
Not yet recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, South Holland, France, 75020
Not yet recruiting
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands, 3015 GD
Not yet recruiting
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Not yet recruiting
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX