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
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.


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     Cediranib 45 mg Fixed Dose     Cediranib 30 to 90 mg Dose Escalation  
STARTED     23     22     0     0  
COMPLETED     18     16     0     0  
NOT COMPLETED     5     6     0     0  
Withdrawal by Subject                 1                 1                 0                 0  
Condition under investigation worsened                 2                 2                 0                 0  
Incorrect enrol/entry crit not fulfilled                 0                 1                 0                 0  
Partial bowel obstruction                 1                 0                 0                 0  
Reaccumul. of ascites following drainage                 0                 1                 0                 0  
Suspicion of second malignancy                 0                 1                 0                 0  
QTC interval outwith elig. criteria                 1                 0                 0                 0  

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

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

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

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

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

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

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

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. ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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