MedTrace Logo

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

NCT04887506 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-01-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tavanta Therapeutics

    lead INDUSTRY

Principal Investigators

  • Andreas Maetzel, MD, PhD · Tavanta Therapeutics inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2022-10-20
Completion
2022-10-20
FDA Drug
Yes

Countries

  • United States
  • France
  • Hungary
  • Poland
  • Puerto Rico
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887506 on ClinicalTrials.gov