NCT04887506

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Tavanta Therapeutics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

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

Interventions

Type	Name	Description
DRUG	TAVT-45	250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice (orange juice), administered twice daily.
DRUG	Zytiga	500 mg tablet, two tablets administered once daily
DRUG	Prednisone	mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2021-05-14
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

42 sites across 8 countries: United States, France, Hungary, Poland, Puerto Rico, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study