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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00537095

First received: September 27, 2007

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Results First Received: April 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, 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, 164 patients were enrolled in the study by 16 centres with a main activity in thyroid cancer in 7 European countries. Among these 164 patients, 145 patients were randomised 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
Number of Participants [units: participants]	72	73	145
Age [units: year] Mean ± Standard Deviation	62.8 ± 11.21	63.8 ± 11.59	63 ± 11.4
Gender [units: Participants]
Female	33	34	67
Male	39	39	78

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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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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Time Frame	No text entered.
Additional Description	For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. All For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo

Reporting Groups

	Description
ZD6474	ZD6474, Vandetanib 300mg
PLACEBO	PLACEBO

Serious Adverse Events

	ZD6474	PLACEBO
Total, serious adverse events
# participants affected / at risk	19/73 (26.03%)	12/72 (16.67%)
Blood and lymphatic system disorders
Lymphadenopathy ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Cardiac disorders
Angina pectoris ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Arrythmia ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Atrial fibrillation ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Atrioventricular block ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Bradyarrythmia ^{† 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Sinus bradycardia ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Torsade de pointe ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Ventricular tachycardia ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Gastrointestinal disorders
Diarrhoea ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Inguinal hernia ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Rectal haemorrhage ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Vomiting ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Infections and infestations
Pneumonia ^{* 1}
# participants affected / at risk	2/73 (2.74%)	1/72 (1.39%)
Appendicitis ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Bronchopneumonia ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Urinary Tract infection viral ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Injury, poisoning and procedural complications
Femur fracture ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Tibia fracture ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Investigations
Electrocardiogramm QT prolonged ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Groin pain ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Muscular weakness ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Nervous system disorders
Syncope ^{* 1}
# participants affected / at risk	1/73 (1.37%)	1/72 (1.39%)
Cerebral hemorrage ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Ischemic stroke ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Loss of conciousness ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Monoparesis ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^{* 1}
# participants affected / at risk	2/73 (2.74%)	0/72 (0.00%)
Haemoptysis ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Interstitial lung disease ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Lung disorder ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Pleural effusion ^{* 1}
# participants affected / at risk	0/73 (0.00%)	1/72 (1.39%)
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Photosensitivity reaction ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Rash ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)
Skin hemorrage ^{* 1}
# participants affected / at risk	1/73 (1.37%)	0/72 (0.00%)

†	Events were collected by systematic assessment
*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 12.1

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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