At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
In Brief
A Phase 3 clinical trial evaluating TAVT-45, Zytiga, and 1 other intervention for Metastatic Castration-resistant Prostate Cancer and 2 related conditions. Completed, enrolled 107 participants across 42 sites in 8 countries.
Detailed Summary
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
Study Details
Timeline
Interventions
250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice (orange juice), administered twice daily.
500 mg tablet, two tablets administered once daily
mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.