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NCT01876784 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer

A Phase 3 study of Differentiated Thyroid Cancer, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 3
Development phase
238
Enrollment target
20
Study locations

NCT01876784 is a Phase 3 study of Differentiated Thyroid Cancer that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 238 participants, above the 55-participant average among 5 other Differentiated Thyroid Cancer trials with a reported enrollment target (333% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01876784, a Phase 3 study of Differentiated Thyroid Cancer, has completed, sponsored by Genzyme, a Sanofi Company.

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

Study Summary

Primary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: * To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. * To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. * To evaluate the safety and tolerability of vandetanib treatment in this participant population.

Conditions Studied

Differentiated Thyroid Cancer

Interventions

  • DRUG Placebo
  • DRUG Vandetanib (SAR390530)

Study Locations (20)

Other

  • Research Site - Porto Alegre
  • Research Site - Ribeirão Preto
  • Research Site - Rio de Janeiro
  • Research Site - São José do Rio Preto
  • Research Site - São Paulo
  • Research Site - Beijing
  • Research Site - Changchun
  • Research Site - Chengdu
  • Research Site - Huangzhou
  • Research Site - Shanghai

Arkansas

  • Research Site - Little Rock

California

  • Research Site - Torrance

Kentucky

  • Research Site - Lexington

Massachusetts

  • Research Site - Boston

Michigan

  • Research Site - Ann Arbor

Missouri

  • Washington University - St Louis

Nebraska

  • Research Site - Omaha

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2013-09-17
Est. Completion 2022-01-22
Phase Phase 3

Sponsor

Genzyme, a Sanofi Company

196 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01876784

The ClinicalTrials.gov registry entry for NCT01876784 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 55-participant average among 5 other Differentiated Thyroid Cancer trials with a reported enrollment target (333% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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

NCT01876784 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Arkansas, California.

Frequently Asked Questions

What is clinical trial NCT01876784 about?

NCT01876784 is a clinical study titled "Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer". Primary Objective: To determine the efficacy (as assessed by progression-free survival \[PFS\]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondar...

What is the current status of trial NCT01876784?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2013-09-17. Estimated completion is 2022-01-22.

What conditions does trial NCT01876784 study?

This clinical trial studies the following conditions: Differentiated Thyroid Cancer.

What interventions are being tested in trial NCT01876784?

The interventions under investigation include: Placebo (DRUG), Vandetanib (SAR390530) (DRUG).

Who is sponsoring clinical trial NCT01876784?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01876784 being conducted?

This trial has 20 study locations across Arkansas, California, Kentucky, Massachusetts, Michigan. 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

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.