Phase 2
Completed N=45
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
Source: ClinicalTrials.gov NCT00306891 ↗Enrolled (actual)
45
Serious AEs
40.7%
Results posted
Nov 2012
Primary outcomePrimary: Part A: Area Under Plasma Concentration-time Curve (AUC) — 1920; 2392 ng*h/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Area Under Plasma Concentration-time Curve (AUC) |
1920; 2392 | — |
| PRIMARY Part A: Maximum Plasma (Peak) Concentration (Cmax) |
87.02; 127.9 | — |
| SECONDARY Part A: AUC (0-t) |
1896; 2348 | — |
| SECONDARY Part A: Time to Peak or Maximum Concentration (Tmax) |
4.59; 3.52 | — |
| SECONDARY Part A: Terminal Phase Half-life (t1/2λz) |
23.99; 24.72 | — |
| SECONDARY Part A: Apparent Total Body Clearance (CL/F) |
23.44; 18.81 | — |
| SECONDARY Part B: Best Overall Response Rate (ORR) |
1; 3 | — |
| SECONDARY Part B: Progression-free Survival (PFS) |
135; 139 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00306891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.