NCT01393119

Phase II, Dose Finding Study of GTx-758

Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: GTx · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.

Detailed description

The original purpose of the study was to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study. The primary endpoint was used to assess the loading dose, while the secondary endpoint was intended to be used to assess maintenance. Due to the study being terminated early, as requested by FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only and not broken out by the maintenance dose.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	GTx-758	3-fluoro-N-( 4-fluorophenyl)-4-hydroxy-N-( 4-hydroxyphenyl) benzamide; a nonsteroidal selective estrogen receptor (ER) a agonist

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-07-13
• Last updated: 2024-04-22
• Results posted: 2024-04-22

Locations

21 sites across 1 country: United States