Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Granulosa Cell Tumor

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms by Histologic Type

Sex Cord-Gonadal Stromal Tumors

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Estrogens

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

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.

Abemaciclib

Els Van Nieuwenhuysen, MD PhD

Tine Ottenbourgs

Hannelore Denys, MD PhD

Frédéric Kridelka, MD

Lauriane Eberst, MD

Coriolan Lebreton, MD

Coriolon Lebreton, MD

Laurence Gladieff, MD

Dominique Berton, MD

Isabelle Ray-Coquard, MD PhD

Frédéric Selle, MD

Ingrid Boere, MD

Hilde Jalving, MD

Inge Baas, MD

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.

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.

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

RECIST is a standard system to measure how cancer responds to different treatments, including chemotherapy, immunotherapy, and radiation therapy.

The DOR is defined as the time from response until disease progression or death in patients who achieve complete or partial response.

The CBR is defined as the proportion of patients with a confirmed complete response (CR), partial response (PR) and stable disease (SD) maintained for at least 24 weeks.

Based on clinically relevant changes from baseline for vital signs and laboratory findings. CTCAE v5.0 uses a range of grades from 1 to 5:

Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = life-threatening Grade 5 = death

PFS is defined as the time from start of treatment until disease progression/relapse or death from any cause. If the specific event (disease progression/relapse, death, whatever comes first) does not occur, PFS will be censored at the date of last tumor assessment. In case no tumor assessment is available, patients will conservatively be censored at the date of first letrozole + abemaciclib dose.

OS is defined as the time from start of treatment until death from any cause. Patients who are still alive at the time of OS analysis will be censored at the last date they were known to be alive.

The EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.

Kom Op Tegen Kanker

Eli Lilly and Company

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Universitaire Ziekenhuizen KU Leuven

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer	NCT05872204	Low Grade Serou... Adult Type Gran...	Abemaciclib Letrozole	18 Years -	Universitaire Ziekenhuizen KU Leuven
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer	NCT05872204	Low Grade Serou... Adult Type Gran...	Abemaciclib Letrozole	18 Years -	Universitaire Ziekenhuizen KU Leuven
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer	NCT05872204	Low Grade Serou... Adult Type Gran...	Abemaciclib Letrozole	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for adult type granulosa cell tumor