An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
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ClinicalTrials.gov Identifier: NCT00410761 |
Recruitment Status :
Active, not recruiting
First Posted : December 13, 2006
Results First Posted : March 26, 2012
Last Update Posted : October 2, 2023
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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Tracking Information | ||||
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First Submitted Date ICMJE | December 6, 2006 | |||
First Posted Date ICMJE | December 13, 2006 | |||
Results First Submitted Date ICMJE | April 27, 2011 | |||
Results First Posted Date ICMJE | March 26, 2012 | |||
Last Update Posted Date | October 2, 2023 | |||
Actual Study Start Date ICMJE | November 30, 2006 | |||
Actual Primary Completion Date | July 31, 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival(PFS) [ Time Frame: RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent. ] Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.
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Original Primary Outcome Measures ICMJE |
To demonstrate an improvement in progression-free survival with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic medullary thyroid cancer. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer | |||
Official Title ICMJE | An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer | |||
Brief Summary | The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Thyroid Cancer | |||
Intervention ICMJE | Drug: ZD6474 (Vandetanib)
once daily oral tablet
Other Names:
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Study Arms ICMJE |
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Publications * | Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24. Erratum In: J Clin Oncol. 2013 Aug 20;31(24):3049. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
437 | |||
Original Enrollment ICMJE |
232 | |||
Estimated Study Completion Date ICMJE | June 28, 2024 | |||
Actual Primary Completion Date | July 31, 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, India, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, United States | |||
Removed Location Countries | Argentina, Bulgaria, China, Czech Republic, Former Serbia and Montenegro, United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00410761 | |||
Other Study ID Numbers ICMJE | D4200C00058 2005-005077-29 ( EudraCT Number ) LPS14811 ( Other Identifier: Sanofi ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Sanofi ( Genzyme, a Sanofi Company ) | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Genzyme, a Sanofi Company | |||
Original Study Sponsor ICMJE | AstraZeneca | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | September 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |