Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

ClinicalTrials.gov Identifier:

NCT00537095

First received: September 27, 2007

Last updated: May 4, 2017

Last verified: May 2017

History of Changes

Results First Received: April 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator; Primary Purpose: Treatment
Condition:	Thyroid Neoplasms
Interventions:	Drug: Vandetanib Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From September 28th, 2007 to October 16th, 2008, 145 patients were randomized by 16 centers in 7 European countries to receive vandetanib 300 mg once daily oral dose or placebo.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The main reason for non-randomisation was non-respect of eligibility criteria

Reporting Groups

	Description
ZD6474	ZD6474, Vandetanib 300mg
PLACEBO	PLACEBO

Participant Flow: Overall Study

	ZD6474	PLACEBO
STARTED	72	73
COMPLETED	21	16
NOT COMPLETED	51	57
surgery	1	0
Adverse Event	24	4
disease progression	21	48
Death	3	1
Withdrawal by Subject	2	2
subjective disease progression	0	1
Incorrect enrolment	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ZD6474	ZD6474, Vandetanib 300mg
PLACEBO	PLACEBO
Total	Total of all reporting groups

Baseline Measures

	ZD6474	PLACEBO	Total
Overall Participants Analyzed [Units: Participants]	72	73	145

Age [Units: Year] Mean (Standard Deviation)	62.8 (11.21)	63.8 (11.59)	63 (11.4)

Sex: Female, Male [Units: Participants] Count of Participants
Female	33 45.8%	34 46.6%	67 46.2%
Male	39 54.2%	39 53.4%	78 53.8%

Outcome Measures

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1. Primary:

Time to Tumor Progression [ Time Frame: Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment ]

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2. Secondary:

Disease Control Rate at 6 Months [ Time Frame: 6 months after randomisation ]

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3. Secondary:

Objective Response Rate [ Time Frame: 46.7 months ]

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Measure Type	Secondary
Measure Title	Objective Response Rate
Measure Description	Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria
Time Frame	46.7 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
ZD6474	ZD6474, Vandetanib 300mg
PLACEBO	PLACEBO

Measured Values

	ZD6474	PLACEBO
Participants Analyzed [Units: Participants]	72	73
Objective Response Rate [Units: Participants]	6	4

No statistical analysis provided for Objective Response Rate

4. Secondary:

Time to Death [ Time Frame: time from randomisation to date of death ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Results Point of Contact:

Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leboulleux S, Bastholt L, Krause T, de la Fouchardiere C, Tennvall J, Awada A, Gómez JM, Bonichon F, Leenhardt L, Soufflet C, Licour M, Schlumberger MJ. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012 Sep;13(9):897-905. doi: 10.1016/S1470-2045(12)70335-2. Epub 2012 Aug 14.

Responsible Party:	Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:	NCT00537095 History of Changes
Other Study ID Numbers:	D4200C00079 2007-001890-27 ( EudraCT Number ) LPS14940 ( Other Identifier: Sanofi )
Study First Received:	September 27, 2007
Results First Received:	April 27, 2011
Last Updated:	May 4, 2017

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