Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00306891

First received: March 23, 2006

Last updated: October 3, 2012

Last verified: October 2012

History of Changes

Results First Received: April 3, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cancer
Interventions:	Drug: Cediranib Drug: Cediranib 30 - 90 mg

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
This was a two part study.Part A had two arms, fed/fasted and fasted/fed. Part B had two arms, a fixed dose arm and a dose escalation arm.Patients(pts)in Part A were allowed to go in to Part B. Pts who chose not to go in to Part B discontinued the study.Additionally new pts were recruited to Part B. In Parts A/B, there was a total of 60 pts.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B. Completion of Part B means completed at least 16 weeks of treatment.

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

60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B.

Completion of Part B means completed at least 16 weeks of treatment.

Reporting Groups

	Description
Cediranib 45 mg Fed	Part A: Cediranib 45 mg Fed State
Cediranib 45 mg Fasted	Part A: Cediranib 45 mg Fasted State
Cediranib 45 mg Fixed Dose	Part B: Cediranib 45 mg Fixed Dose
Cediranib 30 to 90 mg Dose Escalation	Part B: Cediranib Dose Escalation

Participant Flow for 2 periods

Period 1: Part A

	Cediranib 45 mg Fed	Cediranib 45 mg Fasted
STARTED	23	22
COMPLETED	18	16
NOT COMPLETED	5	6
Withdrawal by Subject	1	1
Condition under investigation worsened	2	2
Incorrect enrol/entry crit not fulfilled	0	1
Partial bowel obstruction	1	0
Reaccumul. of ascites following drainage	0	1
Suspicion of second malignancy	0	1
QTC interval outwith elig. criteria	1	0

Period 2: Part B

	Cediranib 45 mg Fixed Dose	Cediranib 30 to 90 mg Dose Escalation
STARTED	16 ^[1]	31 ^[2]
COMPLETED	5	14
NOT COMPLETED	11	17
Death	1	2
Adverse Event	5	5
Withdrawal by Subject	3	1
Condition under investigation worsened	2	8
Development of study specific disc crit.	0	1

[1]	In Part B: Cediranib 45 mg Fixed Dose 4 new patients were randomized
[2]	in Part B: Cediranib Dose Escalation 11 new patients were randomized.

Baseline Characteristics

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Reporting Groups

	Description
Cediranib 45 mg Fed	Part A: Cediranib 45 mg Fed State
Cediranib 45 mg Fasted	Part A: Cediranib 45 mg Fasted State
Cediranib 45 mg Fixed Dose	Part B: Cediranib 45 mg Fixed Dose
Cediranib 30 to 90 mg Dose Escalation	Part B: Cediranib Dose Escalation
Total	Total of all reporting groups

Baseline Measures

	Cediranib 45 mg Fed	Cediranib 45 mg Fasted	Cediranib 45 mg Fixed Dose	Cediranib 30 to 90 mg Dose Escalation	Total
Number of Participants [units: participants]	23	22	16	31	92
Age [units: Years] Mean ± Standard Deviation	58.6 ± 10.6	51.2 ± 14.8	56.4 ± 13.1	56.0 ± 13.5	56.0 ± 13.0
Gender, Customized [units: participants]
Female, Part A	10	10	NA ^[1]	NA ^[2]	20
Male, Part A	13	12	NA ^[3]	NA ^[2]	25
Female, Part B	NA ^[4]	NA ^[5]	8	12	20
Male, Part B	NA ^[6]	NA ^[5]	8	19	27

[1]	Cediranib 45 mg Fixed dose arm existed only in Part B.
[2]	Cediranib 30 to 90 mg Dose Escalation existed only in Part B.
[3]	Cediranib 45 mg Fixed dose arm existed only in Part B
[4]	Cediranib 45 mg Fed/Fasted existed only in Part A.
[5]	Cediranib 45 mg Fasted/Fed existed only in Part A.
[6]	Cediranib 45 mg Fed/Fasted only in Part A.

Outcome Measures

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1. Primary:

Part A: Area Under Plasma Concentration-time Curve (AUC) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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2. Primary:

Part A: Maximum Plasma (Peak) Concentration (Cmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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3. Secondary:

Part A: AUC (0-t) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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4. Secondary:

Part A: Time to Peak or Maximum Concentration (Tmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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5. Secondary:

Part A: Terminal Phase Half-life (t1/2λz) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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6. Secondary:

Part A: Apparent Total Body Clearance (CL/F) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]

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7. Secondary:

Part B: Best Overall Response Rate (ORR) [ Time Frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation. ]

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8. Secondary:

Part B: Progression-free Survival (PFS) [ Time Frame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. ]

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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:	NCT00306891 History of Changes
Other Study ID Numbers:	D8480C00021, 2005-003441-13
Study First Received:	March 23, 2006
Results First Received:	April 3, 2012
Last Updated:	October 3, 2012
Health Authority:	United Kingdom: Department of Health

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