TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a Phase 3 randomized, open-label study to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) in patients with high-risk metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC). Randomization was stratified by prostate cancer population (CSPC vs CRPC) and baseline testosterone (<10 vs ≥ 10 ng/dL). Patients were treated for 84 days and randomized into one of two groups in a 1:1 ratio:

• TAVT-45: Administered twice daily as 1 x sachet containing TAVT-45 (250 mg abiraterone acetate), reconstituted in water or specified fruit juice (orange juice), + Prednisone (5 mg once or twice daily, depending on prostate cancer population)

• R-AA: Administered once daily as (2 x 500 mg Zytiga tablets) + Prednisone (5 mg once or twice daily, depending on prostate cancer population) ;

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Metastatic Castration-sensitive Prostate Cancer
• Metastatic Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04887506
• Study type: Interventional
• Source: Tavanta Therapeutics
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2021
• Completion date: October 20, 2022