Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer
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| ClinicalTrials.gov Identifier: NCT00537095 |
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Recruitment Status :
Completed
First Posted : September 28, 2007
Results First Posted : July 8, 2011
Last Update Posted : April 19, 2024
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Thyroid Neoplasms |
| Interventions |
Drug: Vandetanib Other: Placebo |
| Enrollment | 164 |
Participant Flow
| Recruitment Details | A total of 164 participants were enrolled in the study, out of which only 145 participants were randomized into 2 arms to receive vandetanib 300 mg once daily oral dose or placebo. Participants were randomized by 16 active centers in 7 European countries from September 28th, 2007 to October 16th, 2008. |
| Pre-assignment Details | The main reason for non-randomization was non-respect of eligibility criteria. |
| Arm/Group Title | ZD6474/ ZD6474 | PLACEBO/ ZD6474 |
|---|---|---|
 Arm/Group Description |
Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first. Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy. | Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first. Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy. |
| Period Title: Randomized Treatment Period (433 Days) | ||
| Started | 72 | 73 |
| Safety Population | 73 [1] | 72 |
| Completed | 0 | 0 |
| Not Completed | 72 | 73 |
| Reason Not Completed | ||
| Adverse Event | 24 | 4 |
| Objective Disease Progression | 21 | 48 |
| Death | 3 | 1 |
| Withdrawal by Subject | 2 | 2 |
| Subjective/ Clinic Progression or Lack of Efficacy | 1 | 2 |
| As per protocol (after 12 months of blinded treatment) | 21 | 16 |
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[1]
One participant in placebo arm received vandetanib (ZD6474) and was thus accounted in the vandetanib group for safety analysis.
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| Period Title: Open-label Period (590 Days) | ||
| Started [1] | 28 | 59 |
| Safety Population | 29 [2] | 58 |
| Completed | 16 | 20 |
| Not Completed | 12 | 39 |
| Reason Not Completed | ||
| Adverse Event | 2 | 11 |
| Objective Disease Progression | 2 | 21 |
| Death | 2 | 2 |
| Withdrawal by Subject | 1 | 2 |
| Subjective/ Clinic Progression or Lack of Efficacy | 5 | 3 |
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[1]
Post completion of randomized treatment period, the participants were given the option to enter the open label period. In the open-label period, all participants received vandetanib (ZD6474).
[2]
One participant in placebo arm of randomized treatment period received vandetanib (ZD6474) and was thus accounted in the vandetanib group for the safety analysis.
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Baseline Characteristics
| Arm/Group Title | ZD6474 | PLACEBO | Total | |
|---|---|---|---|---|
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Arm/Group Description |
ZD6474, Vandetanib 300mg | PLACEBO | Total of all reporting groups | |
| Overall Number of Baseline Participants | 72 | 73 | 145 | |
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Baseline Analysis Population Description |
Analysis was performed on intent to treat (ITT) population which included all randomized participants who received at least one dose of study treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Year |
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| Number Analyzed | 72 participants | 73 participants | 145 participants | |
| 62.8 (11.21) | 63.8 (11.59) | 63 (11.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 72 participants | 73 participants | 145 participants | |
| Female |
33 45.8%
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34 46.6%
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67 46.2%
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| Male |
39 54.2%
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39 53.4%
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78 53.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
| Name/Title: | Trial Transparency Team |
| Organization: | Sanofi |
| Phone: | 800-633-1610 ext 6# |
| EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi ( Genzyme, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT00537095 |
| Other Study ID Numbers: |
D4200C00079 2007-001890-27 ( EudraCT Number ) LPS14940 ( Other Identifier: Sanofi ) |
| First Submitted: | September 27, 2007 |
| First Posted: | September 28, 2007 |
| Results First Submitted: | April 27, 2011 |
| Results First Posted: | July 8, 2011 |
| Last Update Posted: | April 19, 2024 |