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Completed

NCT Number: NCT00306891

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

The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Glasgow, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of advanced solid tumour.
  • Ability to eat a high fat breakfast

Exclusion criteria

  • Poorly controlled high blood pressure.
  • History of significant gastrointestinal problems

Treatment and study plan

Cediranib

Drug

45 mg oral dose

Other names: RECENTIN™

Cediranib 30 - 90 mg

Drug

oral tablet dose escalation

Other names: RECENTIN™

Primary outcomes

  1. Part A: Area Under Plasma Concentration-time Curve (AUC)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Area under plasma concentration-time curve from zero to infinity

  2. Part A: Maximum Plasma (Peak) Concentration (Cmax)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Maximum plasma drug concentration

Secondary outcomes

  1. Part A: AUC (0-t)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Area under the curve from time 0 to the last measureable time point

  2. Part A: Time to Peak or Maximum Concentration (Tmax)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Time to reach peak or maximum concentration or maximum response

  3. Part A: Terminal Phase Half-life (t1/2λz)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Terminal phase half-life

  4. Part A: Apparent Total Body Clearance (CL/F)

    Time frame: Measurements were collected up to 168 hours (following single dosing).

    Apparent total body clearance of drug from plasma

  5. Part B: Best Overall Response Rate (ORR)

    Time frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.

    Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.

    Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions

  6. 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.

    Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).

    Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.

    Progression (PD) Unequivocal progression of existing non-target lesions.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2006
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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