NCT05872204

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Grade Serous Ovarian Carcinoma
• Adult Type Granulosa Cell Tumor

Interventions

Type	Name	Description
DRUG	Abemaciclib	150 mg tablet twice daily
DRUG	Letrozole	2.5 mg tablet once daily

Timeline

• Start date: 2023-11-30
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-05-24
• Last updated: 2025-03-19

Locations

12 sites across 3 countries: Belgium, France, Netherlands

Regulatory

• FDA-regulated drug study