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