This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™) (NCT00306891), a randomized phase 2 study. The primary outcome is Part A: Area Under Plasma Concentration-time Curve (AUC).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00306891 |
| Phase | Phase 2 |
| Condition | Cancer |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | 2 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced solid tumours were enrolled in this phase 2 study. The registry record reports overall enrollment of 60. The number contributing to each posted result varies, and the record does not explain those differences.
Intervention
In Part A, the study examined a single oral dose of cediranib 45 mg in fed and fasted conditions. Part B assessed safety and tolerability during fixed 45 mg daily dosing and dose escalation from 30 to 90 mg.
Comparator
For the primary pharmacokinetic question, the posted results describe the 45 mg fed and fasted groups. The study is identified as randomized and crossover, but the registry record does not report the sequence, period-specific results, or a paired comparison.
Primary question
The primary endpoint was area under the plasma concentration-time curve from zero to infinity after single dosing. It addresses whether measured cediranib exposure differed between fed and fasted conditions. The registry record reports geometric means and full ranges, but not a treatment contrast, confidence interval, or inferential test for this endpoint.
3. Trial Design
This was a randomized, open-label, phase 2 study with a crossover model. It enrolled patients with advanced solid tumours and was conducted by AstraZeneca. The registry record gives a start date of 2006-06, a primary completion date of 2008-01, and a completed status.
The study had two parts with distinct purposes. Part A examined the effect of food on pharmacokinetics after a single oral dose of cediranib 45 mg. The named conditions were fed and fasted. Measurements were collected up to 168 hours following single dosing. Part B assessed safety and tolerability during fixed daily dosing and an individualized dose-escalation approach. The fixed dose was 45 mg; the escalation range was 30 to 90 mg.
The registry record identifies randomization and crossover but does not describe how participants were assigned to treatment sequences, how long periods lasted, whether a washout was used, or how period and sequence effects were handled. It also does not report how participants moved between Part A and Part B. Those details are important for understanding the design and the populations contributing to each result, so their absence limits reconstruction of the study procedures.
Overall enrollment was 60. The posted primary endpoint summaries list 30 participants in the fed group and 32 in the fasted group, while the Part A safety group lists 39 participants. Part B safety groups and the response outcome also have their own reported counts. These figures describe different reported groups; the registry record does not explain the relationship among them or provide a participant-flow account. The record names six secondary outcomes, including pharmacokinetic measures and Part B response and progression outcomes, but the numerical reporting is incomplete for an overall assessment of those outcomes.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before 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.
Part A
| Stage | 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 |
Reasons for not completing this period:
| Reason | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation |
|---|---|---|---|---|
| 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 |
Part B
| Stage | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation |
|---|---|---|---|---|
| STARTED | 0 | 0 | 16 | 31 |
| COMPLETED | 0 | 0 | 5 | 14 |
| NOT COMPLETED | 0 | 0 | 11 | 17 |
Reasons for not completing this period:
| Reason | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation |
|---|---|---|---|---|
| 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 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 23 | 22 | 16 | 31 | 92 | |
| Age Continuous | Years | 58.6 (SD 10.6) | 51.2 (SD 14.8) | 56.4 (SD 13.1) | 56.0 (SD 13.5) | 56.0 (SD 13.0) |
| Sex/Gender, Customized: Female, Part A | participants | 10 | 10 | NA | NA | 20 |
| Sex/Gender, Customized: Male, Part A | participants | 13 | 12 | NA | NA | 25 |
| Sex/Gender, Customized: Female, Part B | participants | NA | NA | 8 | 12 | 20 |
| Sex/Gender, Customized: Male, Part B | participants | NA | NA | 8 | 19 | 27 |
6. Primary Endpoint
The registry lists the primary outcome as Part A: Area Under Plasma Concentration-time Curve (AUC), measured over Measurements were collected up to 168 hours (following single dosing)..
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Full Range |
| Unit | ng*h/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was area under the plasma concentration-time curve from zero to infinity, reported in ng*h/mL. AUC represents the integrated plasma concentration of a drug over time. As a general pharmacokinetic concept, it is used to describe overall measured exposure rather than the concentration at a single sampling time. Comparing AUC under fed and fasted conditions addresses whether food is associated with a difference in exposure after dosing.
The registry record says measurements were collected up to 168 hours following single dosing. The reported endpoint parameter is a geometric mean, accompanied by the full range. The fed group has a geometric mean of 1920.0, with a range from 778.0 to 5760.0. The fasted group has a geometric mean of 2392.0, with a range from 604.0 to 5730.0. The fasted group’s reported geometric mean is numerically higher, while the ranges overlap broadly.
These summaries describe the observed values but do not by themselves quantify the fed-versus-fasted treatment effect with an uncertainty interval. The registry record does not report a paired AUC contrast, confidence interval, or test for the primary endpoint. Because the study is identified as a crossover, a paired analysis would ordinarily be relevant to interpretation; whether such an analysis was performed is not reported in the registry record. The summaries therefore support a descriptive account of the posted exposure measurements, not a definitive estimate of the within-participant food effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint measures drug exposure following a single dose, not tumour response or clinical benefit. In the fed group, the posted geometric mean AUC is 1920.0 ng*h/mL, and in the fasted group it is 2392.0 ng*h/mL. The fasted summary is numerically higher. The full ranges extend from 778.0 to 5760.0 for the fed group and from 604.0 to 5730.0 for the fasted group. The ranges overlap, and the summaries alone do not establish whether the observed difference is more than sampling variation.
The record gives no primary-endpoint treatment contrast, confidence interval, or inferential test. It therefore does not quantify the precision of the fed-versus-fasted difference or establish a statistical conclusion about the food effect. The reported group sizes are 30 and 32, but the record does not explain why these differ in a study described as crossover, or whether the displayed summaries use all available paired observations. No paired estimate is reported, and the handling of incomplete measurements is not reported in the registry record.
These distinctions matter because a geometric mean and a range answer different questions. The geometric mean describes the central value on a multiplicative scale, while the range records the minimum and maximum observations. Neither gives a confidence interval for the contrast between conditions. As a general statistical point, uncertainty about a comparison depends on the variability of the paired differences in a crossover study, not just on the separate ranges for each condition. Those paired differences are not reported.
The Part B response information is a separate clinical outcome and should not be treated as confirmation of the Part A pharmacokinetic result. The registry reports a numerical risk difference for the dose-escalation group versus fixed dosing, but its confidence interval extends across zero and the unadjusted p-value is 0.687. This is an imprecise secondary comparison, and it is not the primary question about food and single-dose exposure. No causal or efficacy conclusion follows from these sparse response data.
In short, the posted primary summaries show different geometric means between fed and fasted conditions, with overlapping full ranges. They do not provide the estimate and uncertainty needed to determine how precisely the conditions differ. The study’s crossover designation makes the absence of paired results especially relevant. The registry record also does not describe a primary analysis plan, population definition, or missing-data approach that could resolve these interpretive limits.
9. Statistical Methods Explained
The registry identifies a randomized, open-label crossover design and reports a geometric mean with a full range for the primary pharmacokinetic endpoint. It does not report the statistical analysis used for the primary fed-versus-fasted comparison. The distinctions below explain what the posted statistics can show and what cannot be recovered from the record.
What does the primary endpoint summarize?
AUC is the area under a concentration-time curve. In general, it combines concentration measurements across a period of observation into a measure of total exposure. The endpoint is defined as the area from zero to infinity, while the registry says measurements were collected up to 168 hours following single dosing. This definition does not mean every participant was observed indefinitely; it describes the endpoint’s extrapolated target. Whether and how the unobserved portion was estimated is not reported in the registry record.
The primary parameter is a geometric mean. In general, geometric means are suited to measurements that vary multiplicatively and are often used when values are right-skewed. They summarize the central tendency on a transformed scale and then return it to the original measurement scale. The record does not state why this parameter was selected, whether values were transformed for analysis, or how observations below or above assay limits were handled.
The full range gives the lowest and highest reported values in each group. It describes the spread of observed values but is sensitive to extremes and does not directly quantify the precision of the group mean or of a treatment contrast. The ranges reported for the fed and fasted conditions overlap. That overlap is descriptive; it is not a formal test of equality and does not determine the uncertainty in a paired comparison.
Why does the crossover description matter?
As a general statistical point, a crossover design measures participants under more than one condition, so each participant can serve as their own comparison. The statistical analysis typically needs to account for the pairing and may need to consider treatment sequence, period, and carryover. These design features can affect the estimate and its uncertainty. The registry identifies the study as crossover but does not report the sequence allocation, period structure, washout, model, or paired analysis. It is not possible to tell from the posted summaries whether the reported group statistics are based on paired observations or how any sequence or period effects were addressed.
The reported counts for the primary endpoint are 30 for fed and 32 for fasted. These counts are not necessarily the count of complete pairs; the registry record does not state that they are. Overall enrollment is 60, while the listed outcome counts and safety-group counts differ. Without a participant-flow account and an analysis-population definition, the reasons for those counts cannot be determined.
What can be inferred from the posted primary statistics?
The fed geometric mean is 1920.0 ng*h/mL and the fasted geometric mean is 2392.0 ng*h/mL. The full ranges are 778.0 to 5760.0 and 604.0 to 5730.0, respectively. These are separate descriptive summaries. The record does not provide a ratio, difference, confidence interval, standard error, or p-value for the primary contrast. Consequently, the precision of the food-effect estimate is not available. The summaries should not be reinterpreted as though they were an adjusted analysis or as though the range were a confidence interval.
A confidence interval, as a general statistical concept, gives a range of values compatible with the data and analysis under its assumptions. It is useful for showing the precision of an estimated contrast. No primary-endpoint confidence interval is reported. A p-value, also as a general concept, measures how unusual data at least as extreme as those observed would be under a specified null model; it does not measure the size or clinical importance of an effect. No primary p-value is reported either.
How should the secondary comparison be read?
The posted response comparison uses a risk difference and includes a confidence interval and an unadjusted p-value. The estimate is 0.037 in the registry, but this has more than three decimal places and is therefore not reproduced. The confidence interval is -0.131 to 0.205, also not reproduced because of its precision. The unadjusted p-value is 0.687. The interval includes zero, so the data are compatible with differences in either direction under that analysis. The result is not a precise estimate of a treatment effect.
As a general concept, an unadjusted p-value does not account for testing multiple outcomes or comparisons. If many questions are tested, the chance of at least one apparently notable result can increase. The record does not report a multiplicity strategy or a detailed analysis plan. The response comparison is secondary and does not answer the primary food-effect question. Its point estimate and uncertainty should be considered as exploratory evidence rather than as a substitute for the primary pharmacokinetic analysis.
What do the planning illustrations mean?
The registry includes sample-size planning illustrations based on the observed response effect. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with effect targets set at 100%, 75%, and 50% of the observed effect. The illustrations give participants per arm for 80% and 90% power. These are planning scenarios, not observed power and not the trial’s original sample-size justification. The record does not report the trial’s own sample-size assumptions or justification.
As a general statistical point, a planning calculation estimates the sample size needed under specified assumptions. It does not change the uncertainty in the completed trial, and it does not establish that the study was designed around the observed effect. Because the illustrations are based on an observed secondary effect, they should not be treated as evidence that the trial had adequate power for its primary pharmacokinetic question.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan describing how multiple outcomes or comparisons were handled. It lists a primary pharmacokinetic outcome and several secondary outcomes, but it does not state whether the secondary analyses were ordered in a hierarchy, whether any multiplicity adjustment was planned, or which comparisons were confirmatory. The available secondary p-value is explicitly unadjusted. Without a stated strategy, secondary findings should be read cautiously, particularly when several outcomes and dosing groups are involved.
Missing-data handling is also not reported in the registry record. The primary outcome counts differ between the fed and fasted summaries, and the overall enrollment and safety-group counts do not map directly onto those endpoint counts. The record does not explain whether differences reflect incomplete sampling, exclusions, withdrawal, or another reason. It also does not define whether the primary analysis included all randomized participants, all participants with any pharmacokinetic measurement, or only complete pairs. The reason for each reported denominator is therefore unclear.
Analysis populations are not described. The registry does not identify an intention-to-treat, per-protocol, pharmacokinetic, or safety population definition, nor does it say whether any participants were excluded from specific analyses. In a crossover study, the number of complete participant pairs is particularly important for interpreting a within-participant contrast. That number and the handling of participants with only one condition measured are not reported in the registry record.
The record also does not report interim analyses, stopping rules, or a primary-endpoint sample-size justification. These omissions do not establish that such procedures were absent; they mean their presence and details are not available in the registry record. Together, the missing analysis-plan, population, and missing-data information makes it difficult to evaluate whether the posted summaries represent the planned analyses or how robust they are to incomplete observations.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cediranib 45 mg Part A | 6 | 39 | 15.4% |
| Cediranib 45 mg Fixed Dose | 9 | 16 | 56.2% |
| Cediranib 30 - 90 mg Dose Escalation | 20 | 31 | 64.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cediranib 45 mg Part A | 34 of 39 |
| Cediranib 45 mg Fixed Dose | 16 of 16 |
| Cediranib 30 - 90 mg Dose Escalation | 31 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Cediranib 45 mg Part A | Cediranib 45 mg Fixed Dose | Cediranib 30 - 90 mg Dose Escalation |
|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | 0 of 39 | 2 of 16 | 3 of 31 |
| Diarrhoea | Gastrointestinal disorders | 0 of 39 | 1 of 16 | 3 of 31 |
| Vomiting | Gastrointestinal disorders | 0 of 39 | 0 of 16 | 3 of 31 |
| Angina Pectoris | Cardiac disorders | 1 of 39 | 1 of 16 | 0 of 31 |
| Pyrexia | General disorders | 0 of 39 | 1 of 16 | 1 of 31 |
| Sepsis | Infections and infestations | 0 of 39 | 1 of 16 | 1 of 31 |
| Dehydration | Metabolism and nutrition disorders | 0 of 39 | 1 of 16 | 1 of 31 |
| Cardiac Failure | Cardiac disorders | 0 of 39 | 1 of 16 | 0 of 31 |
| Abdominal Pain Lower | Gastrointestinal disorders | 1 of 39 | 0 of 16 | 0 of 31 |
| Constipation | Gastrointestinal disorders | 0 of 39 | 0 of 16 | 1 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cediranib 45 mg Part A | Cediranib 45 mg Fixed Dose | Cediranib 30 - 90 mg Dose Escalation |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 5 of 39 | 13 of 16 | 25 of 31 |
| Hypertension | Vascular disorders | 9 of 39 | 10 of 16 | 23 of 31 |
| Nausea | Gastrointestinal disorders | 9 of 39 | 11 of 16 | 17 of 31 |
| Vomiting | Gastrointestinal disorders | 4 of 39 | 10 of 16 | 14 of 31 |
| Constipation | Gastrointestinal disorders | 4 of 39 | 10 of 16 | 10 of 31 |
| Fatigue | General disorders | 8 of 39 | 5 of 16 | 10 of 31 |
| Lethargy | Nervous system disorders | 8 of 39 | 4 of 16 | 7 of 31 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 39 | 4 of 16 | 9 of 31 |
| Decreased Appetite | Metabolism and nutrition disorders | 2 of 39 | 4 of 16 | 8 of 31 |
| Stomatitis | Gastrointestinal disorders | 0 of 39 | 4 of 16 | 9 of 31 |
Serious events with the highest arm-level rate: abdominal pain (12.5%), diarrhoea (9.7%), vomiting (9.7%), angina pectoris (6.2%), cardiac failure (6.2%).
The registry reports safety counts for three groups: cediranib 45 mg in Part A, fixed-dose cediranib 45 mg in Part B, and cediranib dose escalation from 30 to 90 mg. Serious adverse events affected 6 of 39 participants in the Part A group, 9 of 16 in the fixed-dose group, and 20 of 31 in the dose-escalation group. Other adverse events affected 34 of 39, 16 of 16, and 31 of 31 participants, respectively. The record does not report deaths for these groups.
These are group-level counts, not comparisons adjusted for differences in exposure, follow-up, or participant characteristics. The registry record does not provide the timing, duration, severity grading, attribution, or treatment discontinuation details needed to interpret individual events. It also does not explain whether participants could appear in more than one group or how the Part A and Part B populations relate. The counts should therefore be read as descriptive safety reporting, not as a basis for comparing the dosing strategies.
The listed serious adverse event terms and percentages include abdominal pain at 12.5%, diarrhoea at 9.7%, vomiting at 9.7%, angina pectoris at 6.2%, cardiac failure at 6.2%, and gastric perforation at 6.2%. The record does not state in this summary how those term percentages were calculated or whether the listed terms overlap within participants. They should not be added together or interpreted as mutually exclusive categories.
12. What the Result Does, and Does Not, Mean
The primary result is a descriptive comparison of AUC geometric means after a single dose under fed and fasted conditions. The reported geometric mean is numerically higher in the fasted group, but the full ranges overlap. The registry record does not provide a primary contrast, confidence interval, or statistical test, so the size and precision of the within-participant food effect cannot be assessed from the posted statistics.
This does not establish that food has no effect, nor does it establish that food changes exposure. A difference between two reported group summaries is not itself a measure of statistical certainty. The crossover design would make a paired treatment contrast relevant, but the record does not report that estimate or the analysis details needed to interpret it. The summaries also do not describe the possible clinical importance of an exposure difference.
The primary endpoint is pharmacokinetic, not an outcome of tumour response, survival, or quality of life. The Part B response information is a separate secondary result, and its uncertainty does not answer the Part A food question. The registry record lists progression-free survival and other secondary outcomes, but available numerical reporting does not support a complete assessment of them. No conclusion about clinical effectiveness follows from the AUC summaries or the limited response comparison.
Safety counts describe events among the reported groups, but they do not establish comparative risk. The registry does not provide enough detail on exposure duration, event attribution, overlap, or participant flow to make a fair comparison across the dosing groups. These limitations are important when interpreting the counts, particularly because the reported group sizes differ.
Overall, the registry record supports a limited descriptive statement: the fed and fasted conditions have different reported geometric mean AUC values, while the primary comparison’s uncertainty is not reported. It does not provide enough information to determine whether that difference is precise, clinically consequential, or robust to the study’s crossover structure and missing observations.
13. Why This Trial Matters Statistically
This trial is statistically interesting because its primary question and design call for a within-participant comparison, yet the posted primary results are separate group summaries. A crossover design can reduce the influence of stable differences between participants when each person receives or experiences both conditions. To assess that advantage, however, readers need a paired estimate and information about period, sequence, and any carryover handling. Those elements are not reported in the registry record.
The distinction between descriptive summaries and an estimated contrast is central. Geometric means and ranges communicate the observed scale and spread of AUC values. They do not provide the uncertainty around the fed-versus-fasted effect. The absence of a confidence interval or test means that readers cannot assess precision from the primary result as posted. This is a useful example of why endpoint values alone do not answer a comparative research question.
The study also illustrates the importance of clearly defining analysis populations. Enrollment, primary outcome counts, and safety denominators differ, but the record does not describe participant flow or explain the denominators. In pharmacokinetic work, incomplete sampling can affect whether an exposure measure is estimable, and in crossover work the number of complete pairs matters. Clear reporting of these details is necessary to judge how much information supports the estimate.
Finally, the registry lists a range of secondary outcomes but provides limited numerical comparisons, and the available secondary p-value is unadjusted. The distinction between planned confirmatory analyses and exploratory analyses is not described. These are common interpretive challenges in clinical trials: the design, endpoint, analysis population, uncertainty, and multiplicity strategy all need to align before a result can answer its intended question.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation is that the primary endpoint is reported as group-level geometric means and ranges without a fed-versus-fasted contrast or confidence interval. The record identifies a crossover design, but it does not report paired results. Consequently, the primary summaries do not show the precision of the comparison or how within-participant information was used.
Several design and analysis details are unavailable. The registry record does not describe treatment sequence, period structure, washout, handling of period or carryover effects, or the statistical model. It does not define analysis populations or explain the different endpoint and safety denominators. It also does not report how incomplete concentration-time profiles or missing observations were handled. These are specific uncertainties for interpreting a single-dose pharmacokinetic endpoint in a crossover study.
The secondary outcome reporting is incomplete for an overall account of the listed outcomes. The record does not report a multiplicity strategy, and the available secondary comparison is unadjusted. No detailed analysis plan, primary sample-size justification, interim-analysis information, or stopping rules are reported. The sample-size illustrations relate to a secondary observed effect and are not evidence about the original design assumptions.
Safety information is also limited to counts and selected serious-event terms. Event timing, duration, severity grading, attribution, exposure time, and the relationship between participant groups are not reported in the registry summary. The listed terms may not be mutually exclusive, and the basis for their percentages is not stated. These limitations prevent a detailed or adjusted comparison of safety across dosing groups.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™) — NCT00306891.
- Registry record last updated 2012-11-01; status last verified 2012-10.
- Results first posted 2012-11-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00306891 is a completed randomized, open-label, phase 2 crossover study sponsored by AstraZeneca. It enrolled 60 patients with advanced solid tumours and began in 2006-06; primary completion was 2008-01. Part A examined AUC after a single oral dose of cediranib 45 mg in fed and fasted conditions, with measurements collected up to 168 hours. Part B assessed safety and tolerability during fixed 45 mg dosing and dose escalation from 30 to 90 mg.
The primary outcome is reported as geometric means with full ranges, but the registry does not report a primary fed-versus-fasted contrast or its uncertainty. Secondary and safety information is also incomplete for reconstructing the analysis populations and comparing groups. The posted statistics therefore support descriptive interpretation, while important details about paired analysis, missing data, multiplicity, and participant flow are not reported in the registry record.