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Active (not recruiting) Phase 2 2025-521327-67-00

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

Phase 2 – studying effectiveness and dosage
Conditions: Metastatic Castration-Resistant Prostate Cancer

Sponsor: F. Hoffmann-La Roche AG

trial.available_in: БГ
Overview
Trial status: Authorised Confirmed Composite Response Rate (RR), Confirmed prostate-specific antigen 90 (PSA90), Confirmed prostate-specific antigen 50 (PSA50), Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results Radiographic Progression-Free Survival (rPFS)
Description
Confirmed Composite Response Rate (RR), Confirmed prostate-specific antigen 90 (PSA90), Confirmed prostate-specific antigen 50 (PSA50), Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results
Who can participate
Age group: 65+ years, 18-64 years Gender: Male Target enrollment: 32 participants
Interventions
INAVOLISIB
Drug
DOCETAXEL
Drug
INAVOLISIB
Drug
ENZALUTAMIDE
Drug
ENZALUTAMIDE
Drug
ABIRATERONE
Drug
Locations 4
France (1)
Germany (1)
Italy (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
06.03.2026
Registry ID
2025-521327-67-00
Source
euclinicaltrials.eu
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