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 Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase (NCT02640755), a non-randomized phase 1 study. The primary outcome is Total Radioactivity in Plasma Following Administration of [14C]-AZD2014.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02640755 |
| Phase | Phase 1 |
| Condition | Solid Malignancies |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced solid malignancies were eligible for the study. The registry describes the pharmacokinetic analysis population as evaluable patients dosed with [14C]-AZD2014 in Cycle 0 who had reportable and evaluable concentration data. It also describes exclusions for vomiting at or before 3 hours after dosing and for identified procedural or scientific issues; the full exclusion wording is not reported in the registry record.
Intervention
The study began with a single oral dose of 125 mg [14C]-AZD2014. The multiple-dose phase then assessed AZD2014 as monotherapy or in combination with fulvestrant or paclitaxel. The registry lists three arm descriptions, each beginning with the [14C]-AZD2014 dose.
Comparator
There was no randomised control group. The study was open-label and non-randomised, so the treatment arms should not be treated as exchangeable groups in a controlled comparison. The registry record does not report a prespecified comparative estimate between the monotherapy and combination arms.
Primary question
The primary endpoint concerns geometric mean total radioactivity in plasma, expressed as AZD2014 concentration equivalents, after the single [14C]-AZD2014 dose. Blood was sampled from pre-dose through 48 hours after dosing. The record states that geometric mean concentrations were not quantifiable after 48 hours. Numeric geometric mean estimates and their geometric coefficients of variation are not reported in the registry record.
The clinical question is therefore descriptive and pharmacokinetic: how much total drug-related radioactivity was measured in plasma at the scheduled sampling times after a single oral dose? The primary outcome is not a direct test of tumour response or a comparison of the three multiple-dose regimens. Safety, best overall response and percentage change in tumour size are listed as secondary outcomes, but the registry record does not provide their complete results in the information available for this account.
The distinction between the single-dose and multiple-dose parts matters. The primary endpoint is tied to the radiolabelled single dose, while later treatment is described as multiple dosing of AZD2014 alone or with another drug. The stated primary question does not establish that one multiple-dose regimen is more effective or safer than another. The non-randomised, open-label design is suited to describing observations in this early-phase study, not to establishing a controlled treatment effect.
3. Trial Design
This was a Phase I, open-label, non-randomised, single-centre study in patients with advanced solid malignancies. The registry identifies the model as parallel and lists three treatment arms: [14C]-AZD2014 followed by AZD2014 monotherapy, [14C]-AZD2014 followed by AZD2014 plus fulvestrant, and [14C]-AZD2014 followed by AZD2014 plus paclitaxel. All listed arms begin with the radiolabelled dose; the subsequent multiple-dose treatment differs by arm.
The study had two stated parts. In the single-dose period, the aim was to characterise absorption, metabolism, excretion and pharmacokinetics after a single oral dose of [14C]AZD2014. The primary endpoint focuses on total radioactivity in plasma following the dose. In the multiple-dose period, the registry describes further assessment of safety, tolerability and anti-tumour activity with AZD2014 given alone or with paclitaxel or fulvestrant.
Enrollment is listed as 4. The registry does not report how participants were distributed across the three arms, and the enrollment figure should not be read as the number included in the pharmacokinetic analysis. That analysis population was described separately as evaluable dosed patients with reportable and evaluable pharmacokinetic concentration data. Further details of the eligibility criteria and the full reasons for exclusion are not reported in the registry record.
Because allocation was non-randomised and masking was absent, treatment assignment was not concealed through a random allocation process and participants and study personnel were not blinded. The registry record does not report the allocation procedure, the rationale for each regimen, or whether particular clinical characteristics determined treatment assignment. Without that information, differences between arms cannot be separated from potential differences in who received each regimen.
The study is recorded as completed. The registry lists a start date of 2016-01-28 and a primary completion date of 2016-12-21. It identifies AstraZeneca as the sponsor. These administrative details describe the registered study but do not supply missing outcome estimates or establish the completeness of outcome reporting.
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: 4 patients were enrolled (signed informed consent). Following \[14C\]-AZD2014, patients either continued AZD2014 as monotherapy or in combination with a standard regimen of fulvestrant or paclitaxel as appropriate and at the Investigator's discretion. No patients were recruited into AZD2014+paclitaxel treatment regimen.
Single Dose Period (Day 1 - 8)
| Stage | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant |
|---|---|---|
| STARTED | 3 | 1 |
| COMPLETED | 3 | 1 |
| NOT COMPLETED | 0 | 0 |
Multiple Dose Period (Day 8 - EoS)
| Stage | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant |
|---|---|---|
| STARTED | 3 | 1 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant |
|---|---|---|
| Condition under investigation worsened | 0 | 1 |
| Subjective progression of disease | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Pharmacokinetic (PK) analysis population consisted of all evaluable patients who were dosed with \[14C\]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.
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.
Population: All patients in the safety analysis set who received at least one dose of radiolabelled or non-radiolabelled AZD2014 were included in the baseline analysis.
| Characteristic | Unit | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 1 | 4 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 1 | 3 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 2 | 1 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Total Radioactivity in Plasma Following Administration of [14C]-AZD2014, measured over Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32 and 48 hours (h) post [14C]-AZD2014 dose in the Single Dose Period..
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanogram equivalent/millilitre (ngEq/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is total radioactivity in plasma after administration of [14C]-AZD2014. The registry describes the measure as a geometric mean concentration in nanogram equivalents per millilitre (ngEq/mL), with dispersion expressed as a geometric coefficient of variation. Plasma radioactivity was converted to AZD2014 concentration equivalents using the actual specific activity of the dose. This is a measure of drug-related radioactivity, rather than a reported concentration of each individual metabolite.
Blood sampling was scheduled on Day 1 at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32 and 48 hours after the dose. The listed schedule allows the concentration profile to be described over time after administration. The registry states that geometric mean concentrations were not quantifiable after 48 hours. It does not provide the numeric values at the scheduled time points in the record.
As a general pharmacokinetic concept, concentration measurements over time can help characterise how drug-related material appears in plasma and how its measurable presence changes after dosing. Geometric means are commonly used for positive concentration measures that can vary multiplicatively; a geometric coefficient of variation describes relative dispersion on a multiplicative scale. These general interpretations do not replace the actual estimates, which are not reported in the registry record.
The endpoint is a pharmacokinetic description following a single radiolabelled dose. It is not itself a measure of tumour shrinkage, clinical benefit, or comparative safety. Nor does total radioactivity alone identify the contribution of the parent compound versus particular metabolites. The registry record does not report separate numeric concentration results for those components.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a small, early-phase study with a pharmacokinetic primary endpoint and a separate multiple-dose phase. Enrollment is listed as 4, while the primary endpoint description refers to a pharmacokinetic analysis population of evaluable patients with reportable concentration data. The number contributing to each endpoint is not reported in the registry record, so enrollment should not be equated with the analysis denominator.
The main result stated for the primary endpoint is that geometric mean concentrations were not quantifiable after 48 hours. This is a statement about quantifiability in the reported concentration profile, not evidence that radioactivity was absent from plasma after that time. The numeric geometric means at earlier times, their geometric coefficients of variation, and the underlying individual measurements are not reported in the registry record. Consequently, the magnitude and precision of the concentration estimates cannot be assessed from the record.
The study has no randomised comparison. Its monotherapy and combination arms are described, but the registry does not report an adjusted or unadjusted treatment contrast, and the allocation process is not reported. Any difference observed between arms could reflect participant characteristics, treatment selection or other factors as well as the regimen. The results should therefore be read as descriptive rather than as evidence from a like-for-like comparison.
The registry lists safety and tumour-response outcomes for the multiple-dose phase, including adverse events, best overall response and best percentage change in tumour size from baseline. It does not provide a complete set of numeric efficacy results in the record. No conclusion about comparative tumour response can be drawn from the listed outcome names alone. Similarly, safety counts do not by themselves establish comparative risk, particularly when the arms are non-randomised and the reported groups are small.
The record lists 28 outcome measures and 0 analyses. The absence of analyses in the registry record means that inferential results such as model-based estimates or hypothesis tests are not reported there. A p-value, confidence interval for a treatment contrast, or adjustment for participant characteristics is not available. The primary concentration estimates and their precision measures are also missing from the information reported.
As a general statistical point, a confidence interval communicates the range of estimates reasonably compatible with the data under a specified method and assumptions. Without the estimates, variability measures, denominators and analysis details, precision cannot be judged. The study can still be understood as an early pharmacokinetic and safety investigation, but the registry record does not support a quantitative comparison of treatment regimens or a precise estimate of a clinical effect.
The design and recorded outcomes are consistent with a descriptive focus: characterising total plasma radioactivity after a single dose and recording safety and tumour-related outcomes during subsequent treatment. Interpretation should remain within that scope. The record does not report a statistical plan, sample-size justification, or a prespecified comparative analysis, so none should be inferred from the endpoint list or study structure.
9. Statistical Methods Explained
What does the geometric mean describe?
The primary concentration measure is a geometric mean. In general, an arithmetic mean adds observed values and divides by their count, whereas a geometric mean is based on multiplying positive values and taking a root. This makes the geometric mean useful for measurements that vary proportionally or multiplicatively, as concentrations often can. It does not show the full distribution: two datasets can share a geometric mean while differing in their spread or individual values.
The registry reports the dispersion measure as a geometric coefficient of variation. In general, this expresses variability relative to the geometric mean on a multiplicative scale. It is different from a standard deviation measured in the original concentration units. The registry record does not provide the coefficient values, so it is not possible to judge how variable the concentrations were at each scheduled time.
What is measured by total radioactivity?
The administered dose was radiolabelled, and the endpoint measures total radioactivity in plasma. The registry says that radioactivity was converted to concentration equivalents of AZD2014 using the actual specific activity of the dose. This supports reporting in ngEq/mL. It does not, by itself, distinguish the parent drug from its metabolites. As a general concept, a radiolabel can be used to follow drug-related material, while identifying individual chemical components requires component-specific analyses. Separate component-specific concentration estimates are not reported in the registry record.
Why collect samples at several times?
Pharmacokinetic concentration measurements are interpreted in relation to time after a dose. A sequence of sampling times can describe the observed concentration profile rather than relying on a single measurement. The schedule ran from pre-dose through 48 hours after dosing, with samples at the times listed in the endpoint description. The registry reports that geometric mean concentrations were not quantifiable after 48 hours. It does not report the concentration values, the number of evaluable samples at each time, or the handling of values below quantification limits.
In general, quantifiability depends on an assay’s ability to measure a concentration reliably under its analytical conditions. A result described as not quantifiable is not necessarily identical to a measured value of zero. The assay limit and the method used to handle unquantifiable observations are not reported in the registry record, so the statement should not be given a more specific interpretation.
What is an analysis population?
The registry describes the pharmacokinetic analysis population as evaluable patients who received [14C]-AZD2014 in Cycle 0 and had reportable and evaluable concentration data. It also notes exclusions for vomiting at or before 3 hours after dosing and for identified procedural or scientific issues, although the full wording is not reported. In general, an analysis population defines which participants contribute to a particular outcome analysis. It can differ from the enrollment count because not every enrolled participant necessarily meets the analysis criteria or has usable measurements.
The number included in the pharmacokinetic population is not reported in the registry record. Nor are the individual reasons for exclusion, the number of missing samples, or the number of observations used at each time point. This prevents a reader from checking how much data contributed to each concentration summary or whether exclusions could have affected interpretation.
What can a non-randomised design establish?
In a randomised study, assignment by chance is intended to reduce systematic differences between treatment groups, on average. In a non-randomised study, that protection is not present. As a general statistical issue, participants receiving different regimens may differ in ways related to treatment selection and outcome. Those differences can make an apparent arm contrast difficult to interpret causally.
This study is identified as non-randomised, open-label and single-centre. The registry lists a parallel model and three regimen descriptions, but does not report the allocation procedure or arm-specific enrollment. The design supports description of observed outcomes in the study groups; it does not by itself make between-arm differences comparable as if treatment had been randomised. No adjustment method or comparative model is reported.
What does a planning calculation mean?
In general, a sample-size calculation is a planning exercise: it estimates the number of participants that might be needed to detect a specified effect under stated assumptions. It is not a summary of the trial’s observed evidence and is not “observed power.” The assumptions described for an illustrative calculation include a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect specified as a fraction of the observed effect. Time-to-event illustrations use a total event count; other illustrations are expressed as participants per arm.
Those assumptions do not establish that they were used to design this study. The registry record does not report the trial’s own sample-size justification, its target effect, or a statistical plan. The observed effect and numerical planning results are not reported in the information, so no sample-size requirement or power estimate can be interpreted for this trial. Any such illustration is hypothetical and should not be presented as evidence that the study was adequately or inadequately powered.
How should uncertainty and multiplicity be considered?
As a general concept, confidence intervals show uncertainty around an estimate, while hypothesis tests assess data against a specified null hypothesis under a statistical model. Neither can be reconstructed responsibly without the necessary estimates, variability, denominators and analysis methods. The registry lists 28 outcome measures and 0 analyses, but does not report confidence intervals, p-values or an inferential analysis plan.
When multiple outcomes are examined, the chance of finding at least one apparently unusual result can increase if each is tested separately without an adjustment. Methods for addressing this include prespecifying a primary outcome, controlling a family-wise error rate, or treating secondary analyses as exploratory. These are general approaches, not descriptions of the analysis used in this trial. A multiplicity strategy is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies total radioactivity in plasma as the primary outcome and lists secondary outcomes for adverse events, best overall response and best percentage change in tumour size from baseline. It records 28 outcome measures and 0 analyses. The record does not report a hierarchy among secondary outcomes, a multiplicity adjustment, or a detailed statistical analysis plan. It is therefore not possible to determine from the registry record how multiple outcomes or repeated measurements were handled in formal inference.
As a general statistical matter, examining many outcomes can create multiple opportunities for a chance finding. Prespecified testing order or adjustment methods can help control the interpretation of multiple comparisons. Conversely, results without such control are often treated as exploratory. These are general considerations, not claims about methods used in this study. The record does not report whether any unregistered analyses were performed.
Missing-data handling is also not reported. For the pharmacokinetic endpoint, the registry defines an evaluable analysis population and describes some exclusions, including vomiting at or before 3 hours after dosing and identified procedural or scientific issues. The complete exclusion wording, counts excluded, missing sample counts, and methods for dealing with unquantifiable concentrations are not reported in the registry record. No imputation method or sensitivity analysis is described.
The participant count contributing to each secondary outcome is not reported. The record also does not explain whether the analysis populations differed across outcomes or how incomplete follow-up was handled. These omissions limit assessment of potential selection effects and the precision of outcome estimates. The reported enrollment figure alone cannot supply the denominators for the primary pharmacokinetic analysis or the multiple-dose outcomes.
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 |
|---|---|---|---|
| [14C]-AZD2014 Then AZD2014 Monotherapy | 1 | 3 | 33.3% |
| [14C]-AZD2014 Then AZD2014 + Fulvestrant | 1 | 1 | 100.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| [14C]-AZD2014 Then AZD2014 Monotherapy | 3 of 3 |
| [14C]-AZD2014 Then AZD2014 + Fulvestrant | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant |
|---|---|---|---|
| Malaise | General disorders | 1 of 3 | 0 of 1 |
| Urinary Tract Infection | Infections and infestations | 0 of 3 | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | [14C]-AZD2014 Then AZD2014 Monotherapy | [14C]-AZD2014 Then AZD2014 + Fulvestrant |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 2 of 3 | 1 of 1 |
| Vomiting | Gastrointestinal disorders | 2 of 3 | 1 of 1 |
| Anaemia | Blood and lymphatic system disorders | 1 of 3 | 1 of 1 |
| Stomatitis | Gastrointestinal disorders | 2 of 3 | 0 of 1 |
| Dry skin | Skin and subcutaneous tissue disorders | 2 of 3 | 0 of 1 |
| Pruritis | Skin and subcutaneous tissue disorders | 2 of 3 | 0 of 1 |
| Mucosal inflammation | General disorders | 1 of 3 | 1 of 1 |
| White blood cell count decreased | Investigations | 1 of 3 | 1 of 1 |
| Candida infection | Infections and infestations | 0 of 3 | 1 of 1 |
| Lower respiratory tract infection | Infections and infestations | 1 of 3 | 0 of 1 |
Serious events with the highest arm-level rate: urinary tract infection (100.0%), malaise (33.3%).
The registry lists serious and other adverse-event figures for two groups: [14C]-AZD2014 followed by AZD2014 monotherapy, and [14C]-AZD2014 followed by AZD2014 plus fulvestrant. For the monotherapy group, the registry records 3 participants at risk for serious adverse events and 1 affected; it records 3 at risk for other adverse events and 3 affected. For the fulvestrant group, it records 1 at risk and 1 affected for serious adverse events, and 1 at risk and 1 affected for other adverse events.
These are group-level counts, not a comparative safety analysis. The groups were not randomised, and the reported counts are small. A difference in counts between groups would not establish that one regimen caused more or fewer events. The registry record does not list serious or other adverse-event figures for the paclitaxel group, so that group cannot be assessed from these figures.
The registry lists urinary tract infection at 100.0% and malaise at 33.3% among the top serious adverse-event terms. The denominators and event-term counting details are not reported in the registry record, so these percentages should be read as listed rather than used to infer a broader risk. Death counts are not reported in the record. These safety entries do not establish the overall safety profile of any regimen.
12. What the Result Does, and Does Not, Mean
The study’s primary result is framed around pharmacokinetics after a single radiolabelled oral dose. The registry says that total radioactivity concentrations were measured at scheduled times through 48 hours, and that geometric mean concentrations were not quantifiable after 48 hours. This conveys the time window of reported quantifiable geometric means, but not the numeric concentration profile or its variability.
The registry record does not report the actual geometric mean concentrations or geometric coefficients of variation. It therefore does not allow a reader to assess the level of radioactivity at particular sampling times, the variation among evaluable participants, or the precision of the estimates. Total radioactivity also does not separately quantify parent AZD2014 and individual metabolites in the information reported.
The record describes later multiple dosing with AZD2014 alone or in combination with fulvestrant or paclitaxel. Its listed secondary outcomes include adverse events and tumour-response measures. Those outcome names indicate what was registered for assessment, not what the results were. The record does not report complete numeric results for these outcomes or a comparative estimate across regimens.
Because allocation was non-randomised and the study was open-label, the treatment groups should not be interpreted as a controlled comparison. The registry does not report the allocation procedure, arm-specific enrollment, or an adjustment for differences among participants. Thus, the record does not establish a causal treatment effect, comparative efficacy, or comparative safety.
As a general principle, absence of a reported estimate is not evidence that the estimate was zero or that no event occurred. Likewise, an outcome’s presence in a registry entry is not evidence of a favourable or unfavourable result. The available information supports a limited description of study design, the primary measurement, and selected safety counts; it does not support a clinical recommendation or a conclusion that a regimen does or does not work.
13. Why This Trial Matters Statistically
This study is statistically notable because it combines a radiolabelled single-dose pharmacokinetic assessment with a later multiple-dose phase. The primary endpoint focuses on total plasma radioactivity after [14C]-AZD2014, while the later phase is described as assessing safety, tolerability and anti-tumour activity with AZD2014 alone or in combination. Keeping these aims distinct helps prevent a pharmacokinetic observation from being mistaken for evidence of tumour response or a comparison of treatment regimens.
The endpoint illustrates how measurement scale affects interpretation. The registry reports geometric means and geometric coefficients of variation, which are useful summaries for concentration data that can vary multiplicatively. It also reports a conversion from radioactivity to AZD2014 concentration equivalents based on the dose’s actual specific activity. These details clarify what the primary measure represents, while the absence of numeric estimates and variability measures limits conclusions about its magnitude and precision.
The non-randomised, open-label design is another important statistical feature. It can support description of observations in the study groups, but it does not balance participant characteristics by random assignment. Without information about allocation or a reported adjustment method, contrasts between monotherapy and combination treatment cannot be interpreted as clean causal comparisons.
The registry’s enrollment figure is 4, but the pharmacokinetic analysis population is defined separately and its size is not reported. This highlights a general distinction between enrollment and the denominator for a specific endpoint. Reporting analysis populations, missing measurements and exclusions is important for understanding how much evidence underlies a result.
Finally, the listed outcome count and lack of recorded analyses underscore the difference between registering outcomes and reporting statistical results. For readers assessing early-phase studies, transparent estimates, uncertainty measures, denominators and analysis methods are essential to determine what the data can support. Those details are not reported in the registry record.
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 most important limitation for statistical interpretation is the lack of numeric primary endpoint results in the registry record. Although the endpoint, unit, summary measure, dispersion measure and sampling schedule are described, the geometric mean concentrations and geometric coefficients of variation are not reported. The statement that concentrations were not quantifiable after 48 hours does not fill in the missing estimates or explain the measurement limits.
Enrollment is listed as 4, but the number contributing to the pharmacokinetic analysis is not reported. The record gives a partial description of exclusions, including vomiting at or before 3 hours after dosing and identified procedural or scientific issues, but the full exclusion wording and the number excluded are not reported. Missing sample handling and the treatment of unquantifiable observations are also not reported.
The study is non-randomised and open-label, and allocation details are not reported. The registry lists three treatment regimens but does not report arm-specific enrollment. This limits interpretation of any apparent differences between groups and prevents assessment of whether participant characteristics differed by regimen. The record does not report a comparative statistical model or adjustment for such differences.
Safety information in the registry is limited to two groups. Serious and other adverse-event counts for the paclitaxel group are not reported. The record also does not report death counts, event-term denominators or a complete accounting of adverse events in the information. Small, non-randomised groups cannot establish comparative safety.
The registry lists secondary tumour-response outcomes but does not report their complete numeric results. It lists 28 outcome measures and 0 analyses; multiplicity methods, missing-data methods, a detailed statistical plan and the study’s own sample-size justification are not reported in the registry record. These gaps constrain evaluation of precision, selective reporting and inferential validity.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase — NCT02640755.
- Registry record last updated 2019-04-22; status last verified 2019-01.
- Results first posted 2019-04-22.
- 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
NCT02640755 is a completed Phase I, open-label, non-randomised, single-centre study in patients with advanced solid malignancies. Enrollment is listed as 4. The study began on 2016-01-28 and its primary completion date is listed as 2016-12-21; AstraZeneca is the sponsor.
The study included a single-dose period with oral 125 mg [14C]-AZD2014 and a multiple-dose period with AZD2014 monotherapy or combination treatment with fulvestrant or paclitaxel. The primary endpoint was total radioactivity in plasma, summarised as geometric mean concentration with geometric coefficient of variation. The registry states that geometric mean concentrations were not quantifiable after 48 hours.
Safety and tumour-response outcomes are listed as secondary outcomes. The registry record does not report the numeric primary concentration estimates, a complete set of secondary results, or a comparative treatment analysis. It records 28 outcome measures and 0 analyses.