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Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
NCT01876784 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2013-09-17 |
| Est. Completion | 2022-01-22 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01876784 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01876784?
The interventions under investigation include: Placebo (DRUG), Vandetanib (SAR390530) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01876784?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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