A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

Официальное название

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

Обзор

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Вмешательства

• Препарат Inavolisib
  Inavolisib will be administered orally as per the schedule specified in the protocol.
• Препарат Enzalutamide
  Enzalutamide will be administered orally as per the schedule specified in the protocol.
• Препарат Abiraterone
  Abiraterone will be administered orally as per the schedule specified in the protocol.
• Препарат Docetaxel
  Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Первичные конечные точки

• Radiographic Progression-free Survival (rPFS) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (7)

• Percentage of Participants with Confirmed Composite Response Rate (RR) [Срок оценки: Up to approximately 5 years]
• Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90) [Срок оценки: Up to approximately 5 years]
• Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50) [Срок оценки: Up to approximately 5 years]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 5 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 5 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 5 years]
• Percentage of Participants With Adverse Events (AEs) [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
• Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA >=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan
• Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC
• Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Fasting glucose <100 mg/dL and HbA1c < 5.7%

Критерии исключения

• Presence of liver metastasis
• Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway
• Type 1 or Type 2 diabetes mellitus
• Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered >28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered >14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered >8 weeks prior to start of treatment
• Other concurrent anti-cancer therapy except for androgen deprivation therapy
• Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment
• Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment

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 · 6 центров

• VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS — Los Angeles
• UCSF — San Francisco
• Holden Comprehensive Cancer Center — Iowa City
• Montefiore Einstein Cancer Center — The Bronx
• Lifespan Cancer Institute — Providence
• Carolina Urologic Research Center — Myrtle Beach

Бразилия · 5 центров

• Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
• CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André
• Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS — São José do Rio Preto
• Instituto Nacional de Cancer - INCa — Rio de Janeiro
• Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP — São Paulo

South Korea · 5 центров

• Seoul National University Bundang Hospital — Seongnam-si
• Seoul National University Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Asan Medical Center. — Seoul
• Samsung Medical Center — Seoul

Turkey (Türkiye) · 5 центров

• Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi — Ankara
• VM Medical Park Samsun Hastanesi — Atakum
• Koc Universitesi Hastanesi — Istanbul
• Izmir Medical Point Hospital — Izmir
• Medical Park Seyhan Hospital — Seyhan

Австралия · 4 центра

• Royal North Shore Hospital-Pacific Hwy — St Leonards
• Sunshine Coast University Hospital — Birtinya
• Royal Brisbane & Womens Hospital — Herston
• Box Hill Hospital — Box Hill

Франция · 4 центра

• EDOG - Institut Bergonie - PPDS — Bordeaux
• Gustave Roussy — Villejuif
• Centre Léon Bérard — Lyon
• Institut Paoli Calmettes — Marseille

Испания · 4 центра

• Hospital Universitario Cruces — Barakaldo
• C.H. Regional Reina Sofia - PPDS — Córdoba
• Hospital Universitario 12 de Octubre — Madrid
• Fundacion Instituto Valenciano de Oncologia (IVO) — Valencia

Канада · 3 центра

• Princess Margaret Cancer Centre — Toronto
• Centre de recherche du Centre Hospitalier de l'Universite de Montreal — Montreal
• Jewish General Hospital — Montreal

Германия · 3 центра

• Universitätsklinikum Freiburg — Freiburg im Breisgau
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• Studienpraxis Urologie — Nürtingen

Италия · 3 центра

• Istituti Fisioterapici Ospitalieri — Rome
• Ospedale San Raffaele S.r.l. - PPDS — Milan
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan

Мексика · 3 центра

• Hospital MAC León — León
• Productos y Servicios Oncologicos Acacias SA de CV — Benito Juárez
• Health Pharma Professional Research S.A de C.V. — Mexico City

Великобритания · 2 центра

• The Royal Marsden in Sutton, Surrey - Downs Rd — Sutton
• Velindre Cancer Centre — Cardiff

Идентификаторы

NCT: NCT07287150 · CO45813 · 2025-521327-67-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗