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NCT01666314 · ClinicalTrials.gov registry record · Phase 1

Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

A Phase 1 study, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
137
Enrollment target

NCT01666314 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 137 participants.

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The verdict

NCT01666314, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
137 participants
Enrollment target

Study Summary

This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

Interventions

  • DRUG Prednisone
  • DRUG Orteronel
  • DRUG Orteronel Placebo

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2012-08-20
Est. Completion 2016-09-01
Phase Phase 1

Sponsor

Millennium Pharmaceuticals

135 total trials

What the Registry Record Tells You About NCT01666314

The ClinicalTrials.gov registry entry for NCT01666314 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.

NCT01666314 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01666314 about?

NCT01666314 is a clinical study titled "Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer". This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer

What is the current status of trial NCT01666314?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2012-08-20. Estimated completion is 2016-09-01.

What interventions are being tested in trial NCT01666314?

The interventions under investigation include: Prednisone (DRUG), Orteronel (DRUG), Orteronel Placebo (DRUG).

Who is sponsoring clinical trial NCT01666314?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

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

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.