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NCT00984282 · ClinicalTrials.gov registry record · Phase 3

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

A Phase 3 study of Thyroid Neoplasms, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
417
Enrollment target
20
Study locations

NCT00984282: Completed Phase 3 study of Thyroid Neoplasms, sponsored by Bayer.

NCT00984282 is a Phase 3 study of Thyroid Neoplasms that has completed, run by Bayer. The registered enrollment target is 417 participants, below the 780-participant average among 7 other Thyroid Neoplasms trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00984282, a Phase 3 study of Thyroid Neoplasms, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
417 participants
Enrollment target
20
Study locations

Study Summary

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Primary Outcome

PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants

Conditions Studied

Thyroid Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Sorafenib (Nexavar, BAY43-9006)

Study Locations (20)

Other

  • - Vienna
  • - Bruxelles - Brussel
  • - Sofia
  • - Beijing
  • - Beijing
  • - Chengdu

California

  • - Los Angeles
  • - Stanford

Pennsylvania

  • - Philadelphia
  • - Pittsburgh

Connecticut

  • - New Haven

Georgia

  • - Atlanta

Massachusetts

  • - Boston

Michigan

  • - Ann Arbor

Missouri

  • - St Louis

Trial Details

FieldValue
Enrollment Target 417 participants
Start Date 2009-10-15
Est. Completion 2017-08-30
Phase Phase 3
Bayer

591 total trials

What the finished NCT00984282 record still lists

NCT00984282 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 780-participant average among 7 other Thyroid Neoplasms trials with a reported enrollment target (47% lower).

The record links to 1 condition, with Thyroid Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00984282 names 20 study sites across 13 states, led by Other, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00984282 about?

NCT00984282 is a clinical study titled "Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer". Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

What is the current status of trial NCT00984282?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2009-10-15. Estimated completion is 2017-08-30.

What conditions does trial NCT00984282 study?

This clinical trial studies the following conditions: Thyroid Neoplasms.

What interventions are being tested in trial NCT00984282?

The interventions under investigation include: Placebo (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG).

Who is sponsoring clinical trial NCT00984282?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00984282 being conducted?

This trial has 20 study locations across California, Connecticut, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00984282, the US trial registry maintained by the National Library of Medicine. NCT00984282 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.