At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
GT0918drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC Who Failed Either Abiraterone or Enzalutamide
In Brief
A Phase 2 clinical trial evaluating GT0918 for Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Completed, enrolled 61 participants across 10 sites.
Detailed Summary
This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment. The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies. Subjects will be randomized into the 2 treatment arms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartMay 2019
Primary CompletionMar 2022
Study CompletionSep 2022
TodayJul 2026
First PostedApr 2, 2019
Enrollment StartMay 30, 2019
Primary CompletionMar 31, 2022
Study CompletionSep 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.3 years ago
Interventions
GT0918drug
anti-tumor activity