Идёт набор NCT07427394

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Фаза II С лечением Advanced Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Camizestrant, Atirmociclib.
Кому может быть актуально: Состояния в реестре: Advanced Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

Обзор

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Подробное описание

This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.

The single-arm study includes:

* Screening period * Atirmociclib single dose period * Doublet intervention period * Post-treatment follow-up period

Вмешательства

Препарат Camizestrant
Camizestrant will be administered orally.
Препарат Atirmociclib
Atirmociclib will be administered orally.

Первичные конечные точки

Number of participants with adverse events (AEs) and serious AEs [Срок оценки: Up to Post-Treatment Follow up (Day 30 Post Dose)]

Вторичные конечные точки (12)

Maximum concentration observed (Cmax) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Time to reach maximum (peak) plasma concentration following drug administration (tmax) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Terminal elimination rate constant (λz) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Terminal elimination half-life (t½λz) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Apparent total body clearance (CL/F) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Apparent volume of distribution at steady state (Vss/F) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Apparent volume of distribution based on the terminal phase (Vz/F) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Maximum concentration observed at steady state (Cssmax) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Area under the curve from 0 to the end of dosing interval (AUC0-tau) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]
Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau) [Срок оценки: At pre-defined intervals from Day -1 to Day 57]

Критерии участия

Main Inclusion Criteria:

Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.
Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.
Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.
At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.
Menopausal status

Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels.
Histological or cytological confirmation of adenocarcinoma of the breast.
Participants of childbearing potential must agree to use one highly effective contraceptive measure.
Documentation of ER-positive tumor irrespective of progesterone receptor status.

Main Exclusion Criteria:

A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
Inability to swallow oral medications.
Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
Presence of life-threatening metastatic visceral disease.
Any evidence of severe or uncontrolled systemic diseases.
Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет