Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00098345

First received: December 7, 2004

Last updated: September 24, 2012

Last verified: September 2012

History of Changes

Results First Received: April 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Thyroid Cancer
Intervention:	Drug: ZD6474 (vandetanib)

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
First patient enrolled 12 November 2004, last patient enrolled 15 August 2006, cut off date 22 February 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Participant Flow: Overall Study

	Caprelsa (Vandetanib) 300 mg
STARTED	30
COMPLETED	17 ^[1]
NOT COMPLETED	13
Adverse Event	7
Withdrawal by Subject	2
progression	4

[1]	ongoing study treatment at data cut-off

Baseline Characteristics

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Reporting Groups

	Description
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Baseline Measures

	Caprelsa (Vandetanib) 300 mg
Number of Participants [units: participants]	30
Age [units: years] Mean ( Full Range )	48.7 ( 20 to 77 )
Gender [units: Participants]
Female	21
Male	9

Outcome Measures

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1. Primary:

Objective Response Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

Measure Type	Primary
Measure Title	Objective Response Rate
Measure Description	The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
Time Frame	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Objective Response Rate [units: Participants]	6

No statistical analysis provided for Objective Response Rate

2. Secondary:

Progression Free Survival [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

Measure Type	Secondary
Measure Title	Progression Free Survival
Measure Description	Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Time Frame	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Safety Issue	No

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.
Upper limit is a censored value

Reporting Groups

	Description
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Progression Free Survival [units: months] Median ( Full Range )	27.9 ( 2.56 to 36.11 )

No statistical analysis provided for Progression Free Survival

3. Secondary:

Duration of Objective Response [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

Measure Type	Secondary
Measure Title	Duration of Objective Response
Measure Description	Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.
Time Frame	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Duration of Objective Response [units: days] Median ( 95% Confidence Interval )	310.5 ( 245 to 402 )

No statistical analysis provided for Duration of Objective Response

4. Secondary:

Disease Control Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

Measure Type	Secondary
Measure Title	Disease Control Rate
Measure Description	Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.
Time Frame	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Disease Control Rate [units: Participants]	22

No statistical analysis provided for Disease Control Rate

5. Secondary:

Biochemical Response Calcitonin (CTN) [ Time Frame: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation ]

Measure Type	Secondary
Measure Title	Biochemical Response Calcitonin (CTN)
Measure Description	A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).
Time Frame	Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Biochemical Response Calcitonin (CTN) [units: Participants]	24

No statistical analysis provided for Biochemical Response Calcitonin (CTN)

6. Secondary:

Symptomatic Response [ Time Frame: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. ]

Measure Type	Secondary
Measure Title	Symptomatic Response
Measure Description	Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.
Time Frame	Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
Symptomatic Response [units: Participants]	0

No statistical analysis provided for Symptomatic Response

7. Secondary:

World Health Organisation (WHO) Performance Status [ Time Frame: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. ]

Measure Type	Secondary
Measure Title	World Health Organisation (WHO) Performance Status
Measure Description	Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)
Time Frame	Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.
Safety Issue	No

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
Caprelsa (Vandetanib) 300 mg	Daily oral dose of Caprelsa (vandetanib) 300mg

Measured Values

	Caprelsa (Vandetanib) 300 mg
Number of Participants Analyzed [units: participants]	30
World Health Organisation (WHO) Performance Status [units: Participants]	4

No statistical analysis provided for World Health Organisation (WHO) Performance Status

Serious Adverse Events

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Other Adverse Events

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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 a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00098345 History of Changes
Other Study ID Numbers:	D4200C00008
Study First Received:	December 7, 2004
Results First Received:	April 27, 2011
Last Updated:	September 24, 2012
Health Authority:	United States: Food and Drug Administration

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