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NCT01977651 · ClinicalTrials.gov registry record · Phase 4

A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

A Phase 4 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 4
Development phase
424
Enrollment target
20
Study locations

NCT01977651 is a Phase 4 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 424 participants, above the 385-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01977651, a Phase 4 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC), has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 4
Development phase
424 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

  • DRUG Enzalutamide

Study Locations (20)

New York

  • Site US10001 - New York
  • Site US10014 - New York
  • Site US10039 - Syracuse
  • Site US10026 - The Bronx

New South Wales

  • Site AU61012 - Kogarah
  • Site AU61005 - Randwick
  • Site AU61011 - Sydney
  • Site AU61001 - Tweed Heads

Other

  • Site AR54003 - Córdoba
  • Site AR54005 - San Miguel de Tucumán
  • Site AR54004 - Santa Fe

Buenos Aires

  • Site AR54001 - Berazategui
  • Site AR54006 - Ciudad Autonoma de BuenosAires

Alaska

  • Site US10005 - Anchorage

Michigan

  • Site US10024 - Detroit

North Carolina

  • Site US10016 - Durham

Texas

  • Site US10008 - Dallas

Trial Details

FieldValue
Enrollment Target 424 participants
Start Date 2013-09-25
Est. Completion 2019-01-11
Phase Phase 4

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01977651

The ClinicalTrials.gov registry entry for NCT01977651 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 385-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (10% higher). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

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

NCT01977651 reports 20 study locations spanning 11 distinct geographic areas - top geographies include New York, New South Wales, Other.

Frequently Asked Questions

What is clinical trial NCT01977651 about?

NCT01977651 is a clinical study titled "A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide". The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

What is the current status of trial NCT01977651?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 424 participants. The study started on 2013-09-25. Estimated completion is 2019-01-11.

What conditions does trial NCT01977651 study?

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

What interventions are being tested in trial NCT01977651?

The interventions under investigation include: Enzalutamide (DRUG).

Who is sponsoring clinical trial NCT01977651?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01977651 being conducted?

This trial has 20 study locations across Alaska, Michigan, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.