Идёт набор NCT06629779

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Фаза III С лечением Metastatic Castration-Resistant Prostate 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: PF-06821497, Placebo, Enzalutamide.
Кому может быть актуально: Состояния в реестре: Metastatic Castration-Resistant Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
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, Аргентина, Бразилия, Болгария, Канада +22
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 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

Обзор

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Подробное описание

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Вмешательства

Препарат PF-06821497
Oral continuous
Препарат Placebo
Oral continuous
Препарат Enzalutamide
Oral continuous

Первичные конечные точки

Radiographic Progression Free Survival (rPFS) [Срок оценки: Randomization up to approximately 3 years]

Вторичные конечные точки (12)

Overall survival (OS) [Срок оценки: Randomization up to approximately 5 years]
To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging Time To Pain Progression (TTPP) [Срок оценки: Randomization up to approximately 5 years]
Objective Response Rate (ORR) [Срок оценки: Randomization up to approximately 3 years]
Duration of Response (DoR) in measurable soft tissue disease [Срок оценки: Randomization up to approximately 3 years.]
Time to prostate specific antigen (PSA) progression. [Срок оценки: Randomization up to approximately 3 years]
Prostate Specific Antigen Response [Срок оценки: Randomization up to approximately 3 years.]
Time to initiation of antineoplastic therapy. [Срок оценки: Randomization up to approximately 5 years.]
Time to initiation of cytotoxic chemotherapy. [Срок оценки: Randomization up to approximately 5 years]
Time to first symptomatic skeletal event [Срок оценки: Randomization up to approximately 3 years.]
Progression free survival on next line of therapy [Срок оценки: Randomization up to approximately 5 years]
Incidence of Adverse Events [Срок оценки: Randomization up to approximately 5 years]
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden. [Срок оценки: Baseline up to approximately 3 years.]

Критерии участия

Критерии включения

Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
Progressive disease in the setting of medical or surgical castration.
ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

Критерии исключения

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:

Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
Inadequate organ function.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение