A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00454116

First received: March 28, 2007

Last updated: April 27, 2011

Last verified: April 2011

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, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Colorectal Cancer
Interventions:	Drug: Vandetanib Drug: FOLFIRI

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 randomised 14 March 2007, last patient randomised 21 Jan 2008, data cut off data 31 March 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI
Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI
Placebo Plus FOLFIRI	placebo plus FOLFIRI

Participant Flow: Overall Study

	Vandetanib 100 mg Plus FOLFIRI	Vandetanib 300 mg Plus FOLFIRI	Placebo Plus FOLFIRI
STARTED	35 ^[1]	36 ^[1]	35 ^[1]
COMPLETED	8 ^[2]	7 ^[2]	7 ^[2]
NOT COMPLETED	27	29	28
Adverse Event	5	11	9
Condition under investigation worsened	17	13	18
Withdrawal by Subject	3	3	1
Other	2	2	0

[1]	randomised patients
[2]	ongoing study treatment at data cut-off

Baseline Characteristics

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Reporting Groups

	Description
Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI
Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI
Placebo Plus FOLFIRI	placebo plus FOLFIRI
Total	Total of all reporting groups

Baseline Measures

	Vandetanib 100 mg Plus FOLFIRI	Vandetanib 300 mg Plus FOLFIRI	Placebo Plus FOLFIRI	Total
Number of Participants [units: participants]	35	36	35	106
Age [units: years] Mean ( Full Range )	57 ( 39 to 80 )	57 ( 30 to 73 )	59 ( 37 to 73 )	58 ( 30 to 80 )
Gender [units: Participants]
Female	15	13	15	43
Male	20	23	20	63

Outcome Measures

1. Primary:

Number of Patients With an Objective Disease Progression Event [ Time Frame: Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days) ]

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Serious Adverse Events

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Additional Description	No text entered.

Reporting Groups

	Description
Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI
Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI
Placebo Plus FOLFIRI	placebo plus FOLFIRI

Serious Adverse Events

	Vandetanib 100 mg Plus FOLFIRI	Vandetanib 300 mg Plus FOLFIRI	Placebo Plus FOLFIRI
Total, serious adverse events
# participants affected / at risk	8/35 (22.86%)	13/36 (36.11%)	12/35 (34.29%)
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	2/36 (5.56%)	0/35 (0.00%)
Cardiac disorders
ATRIAL FIBRILLATION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	2/35 (5.71%)
ANGINA PECTORIS ^{† 1}
# participants affected / at risk	1/35 (2.86%)	1/36 (2.78%)	0/35 (0.00%)
PERICARDIAL EFFUSION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
Gastrointestinal disorders
DIARRHOEA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	3/36 (8.33%)	2/35 (5.71%)
GASTROINTESTINAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	2/35 (5.71%)
ILEUS ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/36 (0.00%)	0/35 (0.00%)
INTESTINAL OBSTRUCTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
PROCTITIS ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/36 (0.00%)	0/35 (0.00%)
RECTAL HAEMORRHAGE ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
General disorders
PYREXIA ^{† 1}
# participants affected / at risk	1/35 (2.86%)	3/36 (8.33%)	3/35 (8.57%)
CHEST PAIN ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/36 (0.00%)	0/35 (0.00%)
Infections and infestations
CENTRAL LINE INFECTION ^{† 1}
# participants affected / at risk	1/35 (2.86%)	2/36 (5.56%)	0/35 (0.00%)
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
CELLULITIS ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/36 (0.00%)	0/35 (0.00%)
EPSTEIN-BARR VIRUS INFECTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
PNEUMONIA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	1/35 (2.86%)
SEPSIS ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
UPPER RESPIRATORY TRACT INFECTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
URINARY TRACT INFECTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
VIRAL INFECTION ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
Metabolism and nutrition disorders
HYPERGLYCAEMIA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
HYPOKALAEMIA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
HYPONATRAEMIA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
Renal and urinary disorders
RENAL FAILURE ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
Respiratory, thoracic and mediastinal disorders
DYSPNOEA ^{† 1}
# participants affected / at risk	0/35 (0.00%)	0/36 (0.00%)	1/35 (2.86%)
PULMONARY EMBOLISM ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	0/35 (0.00%)
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/36 (0.00%)	0/35 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.1

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
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Results Point of Contact:

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

No publications provided

Responsible Party:	MSD
ClinicalTrials.gov Identifier:	NCT00454116 History of Changes
Other Study ID Numbers:	D4200C00048
Study First Received:	March 28, 2007
Results First Received:	April 27, 2011
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration

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