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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: Completed Phase 3 study of Differentiated Thyroid Cancer, sponsored by Genzyme, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or mo
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 |
What the finished NCT01876784 record still lists
NCT01876784 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 55-participant average among 5 other Differentiated Thyroid Cancer trials with a reported enrollment target (333% higher).
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 names 20 study sites across 11 states, led by 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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