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NCT02826772 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer

A Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC), sponsored by Suzhou Kintor Pharmaceutical Inc,.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
6
Study locations

NCT02826772 is a Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC) that has completed, run by Suzhou Kintor Pharmaceutical Inc,. The registered enrollment target is 40 participants, below the 237-participant average among 3 other Metastatic Castrate Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (83% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT02826772, a Phase 1 study of Metastatic Castrate Resistant Prostate Cancer (mCRPC), has completed, sponsored by Suzhou Kintor Pharmaceutical Inc,.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
6
Study locations

Study Summary

This was a Phase 1, multicenter, open-label, clinical trial in adult subjects with metastatic castrate resistant prostate cancer who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either or both therapies. The study involved a Phase 1 dose escalation of oral GT0918 to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.

Interventions

  • DRUG GT0918

Study Locations (6)

Maryland

  • Chesapeake Urology Research Associates - Towson

Nebraska

  • G U Research Network - Omaha

Nevada

  • Comprehensive Cancer Centers of Nevada - Las Vegas

New Jersey

  • Rutgers University - New Brunswick

New York

  • North Shore Hematology Oncology Associates - East Setauket

Ohio

  • Gabrail Cancer Center Research - Canton

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2016-02-10
Est. Completion 2020-02-15
Phase Phase 1

What the Registry Record Tells You About NCT02826772

The ClinicalTrials.gov registry entry for NCT02826772 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 237-participant average among 3 other Metastatic Castrate Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (83% lower). The listed sponsor is Suzhou Kintor Pharmaceutical Inc,, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Castrate Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 1 intervention - of which GT0918 is the first listed.

NCT02826772 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Maryland, Nebraska, Nevada.

Frequently Asked Questions

What is clinical trial NCT02826772 about?

NCT02826772 is a clinical study titled "Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer". This was a Phase 1, multicenter, open-label, clinical trial in adult subjects with metastatic castrate resistant prostate cancer who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either or both therapies. The study involved a P...

What is the current status of trial NCT02826772?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-02-10. Estimated completion is 2020-02-15.

What conditions does trial NCT02826772 study?

This clinical trial studies the following conditions: Metastatic Castrate Resistant Prostate Cancer (mCRPC).

What interventions are being tested in trial NCT02826772?

The interventions under investigation include: GT0918 (DRUG).

Who is sponsoring clinical trial NCT02826772?

This trial is sponsored by Suzhou Kintor Pharmaceutical Inc,, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02826772 being conducted?

This trial has 6 study locations across Maryland, Nebraska, Nevada, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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