Идёт набор NCT06925737

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Фаза III С лечением Prostate Cancer Prostatic Neoplasms

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: Ifinatamab deruxtecan, Docetaxel, Prednisone, Rescue Medication.
Кому может быть актуально: Состояния в реестре: Prostate Cancer, Prostatic Neoplasms. 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, Австралия, Австрия, Бразилия +30
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, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Обзор

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

Вмешательства

Препарат Ifinatamab deruxtecan
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Препарат Docetaxel
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Препарат Prednisone
Oral tablet administered once per day or per approved product label
Препарат Rescue Medication
Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to approximately 36 months]
Radiographic Progression Free Survival (rPFS) [Срок оценки: Up to approximately 36 months]

Вторичные конечные точки (9)

Time to First Subsequent Therapy (TFST) [Срок оценки: Up to approximately 36 months]
Objective Response Rate (ORR) [Срок оценки: Up to approximately 36 months]
Duration of Response (DOR) [Срок оценки: Up to approximately 36 months]
Time to Pain Progression (TTPP) [Срок оценки: Up to approximately 36 months]
Time to Prostate-specific Antigen (PSA) Progression [Срок оценки: Up to approximately 36 months]
PSA Response Rate [Срок оценки: Up to approximately 36 months]
Time to First Symptomatic Skeletal-Related Event (SSRE) [Срок оценки: Up to approximately 36 months]
Number of Participants Who Experienced at Least One Adverse Event (AE) [Срок оценки: Up to approximately 36 months]
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
Has recovered from adverse events (AEs) due to previous anticancer therapies

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Is unable to swallow tablets/capsules
Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:

Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
Has current ILD/pneumonitis
Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Has uncontrolled or significant cardiovascular disease
Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
Has a "superscan" bone scan

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: Открытое
Основная цель: Лечение

Центры проведения

США · 51 центр

Mayo Clinic in Arizona - Phoenix ( Site 0044) — Phoenix
City of Hope Comprehensive Cancer Center ( Site 0049) — Duarte
City of Hope Lennar Foundation Cancer Center ( Site 0059) — Irvine
Moores Cancer Center ( Site 0010) — La Jolla
Veterans Affairs Long Beach Healthcare System ( Site 0058) — Long Beach
Cedars-Sinai Medical Center ( Site 0068) — Los Angeles
UCLA Hematology/Oncology - Santa Monica ( Site 0002) — Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) — Orange
… и ещё 43 центра

Китай · 34 центра

Peking University First Hospital ( Site 1434) — Пекин
Shanghai General Hospital ( Site 1449) — Пекин
The First Affiliated Hospital of Chonqing Medical University ( Site 1406) — Чунцин
Chongqing University Three Gorges Hospital ( Site 1405) — Чунцин
… и ещё 30 центров

Япония · 31 центр