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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

• Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.

• Histological confirmation of diagnosis of low-grade serous (original diagnosis of low-grade serous carcinoma or original diagnosis of serous borderline tumor with subsequent diagnosis of low-grade serous carcinoma )or low-grade endometrioid carcinoma of ovary, fallopian tube or peritoneum or granulosa-cell tumor of the adult type and ER positivity on immunohistochemistry. In order to prevent inclusion of patients with high-grade serous carcinoma, diagnosis of low-grade serous carcinoma will be verified as part of screening review by a gynecologic pathologist. Tissue for confirmation can be from primary tumor or recurrence.

• For Stage 1: only patients where platinum is still an option are eligible with no limitations in prior chemotherapy regimens and a maximum of 2 prior endocrine therapy regimens. For Stage 2: a further 20 patients where platinum is still an option will be included, with no limitations in prior chemotherapy regimens and a maximum of 2 prior endocrine therapy regimens. Fifteen patients where platinum is not an option are allowed with no limitations in prior chemotherapy regimens and maximum of 2 prior endocrine therapy regimens. Patients cannot have received chemotherapy for platinum resistant or refractory disease.

• Age \> 18 years at time of study entry.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

• Patient must have recurrent, measurable disease by RECIST v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded). Each lesion must be ≥10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or must be ≥20 mm when measured by chest x-ray. Lymph nodes must be \>15 mm in short axis when measured by CT or MRI.

• Pre- and post-treatment tissue biopsy and ct-DNA blood sample are mandatory for translational studies. Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.

• Patients who were previously treated with letrozole or another aromatase inhibitor are allowed, but capped at 10 patients in each cohort.

⁃ Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.

⁃ Patients must not have remaining ovarian function. In women who have at least one retained ovary, menopause must be confirmed with laboratory confirmation. Women who have ovarian function are eligible but must be placed on hormonal suppression after a negative serum or urine human chorionic gonadotropin (hCG) test.

⁃ Abnormal organ function is permitted. However, patients must have:

∙ absolute neutrophil count ≥1500/mL

‣ platelets ≥100.000/mL

‣ hemoglobin ≥9 g/dL

‣ estimated creatinine clearance ≥ 45 ml/min as calculated using the method standard for the institution

‣ total serum bilirubin ≤1.5 X ULN

‣ aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≤3 X ULN

‣ alkaline phosphatase ≤2.5x ULN (or ≤5.0x ULN if liver or bone metastases)

Locations
Other Locations
Belgium
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Groupe Hospitalier Diaconesses Croix Saint Simon
RECRUITING
Paris
Institut De Cancerologie De L'Ouest
RECRUITING
Saint-herblain
Institut De Cancerologie Strasbourg Europe
RECRUITING
Strasbourg
Institut Universitaire Du Cancer Toulouse-Oncopole
RECRUITING
Toulouse
Netherlands
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Erasmus Medical Center Rotterdam
RECRUITING
Rotterdam
University Medical Center Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Els Van Nieuwenhuysen, MD PhD
els.vannieuwenhuysen@uzleuven.be
+3216342531
Backup
Tine Ottenbourgs
tine.ottenbourgs@uzleuven.be
+3216348131
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2028-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company, Kom Op Tegen Kanker, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov