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The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

NCT03899467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-02-12

Study results available
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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.

Conditions

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)
  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

GT0918

anti-tumor activity

Sponsors & Collaborators

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2022-03-31
Completion
2022-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03899467 on ClinicalTrials.gov