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 A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients (NCT03165955), a na phase 1 study. The primary outcome is PK Parameters for paclitaxel_AUC (0-52).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03165955 |
| Phase | Phase 1 |
| Condition | Breastcancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 28 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Health Hope Pharma |
| Results posted | Yes |
2. Clinical Question
Population
Patients with breast cancer for whom paclitaxel treatment was indicated were eligible for this multicenter study. The record lists 28 enrolled participants and reports that 25 completed the two-period pharmacokinetic assessment. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Participants received Oraxol, described in the record as oral paclitaxel plus HM30181. The stated regimen was 205 mg/m2 daily for three days weekly, for up to 16 weeks. The study was open-label, so masking was not used.
Comparator
There was no comparator arm. The study is listed as single-group, with allocation recorded as not applicable. Its findings therefore describe participants receiving Oraxol; they do not provide a randomized, like-for-like estimate against another treatment or a control condition.
Primary question
The primary outcome was the mean paclitaxel AUC (0-52), in ng*hr/mL. AUC is a pharmacokinetic measure of drug exposure over time. The registry describes sampling before dosing and at specified post-dose times on study days at week 1 and week 4. Although the outcome is identified and its summary method is stated, the result itself—the mean and standard deviation—is not reported in the registry record. The study therefore identifies the intended exposure question but does not provide a numerical answer in its posted outcome data.
3. Trial Design
This completed phase 1 study was a multicenter, open-label, single-arm pharmacokinetic study in breast cancer patients for whom paclitaxel treatment was indicated. Health Hope Pharma is listed as the sponsor. The record gives a start date of 2017-05-09 and a primary completion date of 2018-11-22. Enrollment was 28. Because there was one treatment group and no masking, the design was intended to describe participants receiving Oraxol rather than compare randomized groups.
The intervention was Oraxol, identified in the adverse-event group description as oral paclitaxel plus HM30181. Participants were to receive 205 mg/m2 daily for three days weekly, for up to 16 weeks. The brief summary describes the study as a pharmacokinetic investigation in patients for whom paclitaxel treatment was indicated. The registry does not report further details about treatment adherence, dose changes, discontinuation, or the exact conduct of the two-period assessment.
The primary outcome was paclitaxel AUC (0-52), measured in ng*hr/mL and summarized using a mean and standard deviation. The specified sampling schedule included predose measurements and measurements at 1, 2, 3, and 4 hours after dosing on days 1, 2, and 3 at week 1 and week 4. The record states that 25 subjects completed the two-period pharmacokinetic assessment. It does not explain why this count differs from total enrollment or identify the analysis population used for each reported outcome.
Safety, response rate, progression-free survival, and overall survival are listed as secondary outcomes. The record lists 14 outcome measures, but no analyses. Results for those secondary outcomes are not reported in the registry record. The study's single-group design is important when reading any descriptive outcome: without a concurrent control group, observed changes or events cannot be interpreted as comparative treatment effects.
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: A total of 31 subjects were screened; 3 subjects were screen failures and were not included in the analysis
Screening/Baseline
| Stage | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|
| STARTED | 31 |
| COMPLETED | 28 |
| NOT COMPLETED | 3 |
Treatment
| Stage | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|
| STARTED | 28 |
| COMPLETED | 20 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|
| Withdrawal by Subject | 3 |
| Death | 1 |
| Adverse Event | 1 |
| Progressive disease | 3 |
Analysis population for the primary outcome, as defined in the registry: Twenty-five subjects completed 2-period PK assessment.
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: A total of 31 subjects were screened; 3 subjects were screen failures and were not included in the analysis
| Characteristic | Unit | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|---|
| Participants analysed | 28 | |
| Age, Continuous | years | 56.6 (SD 9.04) |
| Sex: Female, Male: Female | Participants | 28 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 28 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Taiwan | participants | 28 |
| ECOG: 0 | Participants | 24 |
| ECOG: 1 | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as PK Parameters for paclitaxel_AUC (0-52), measured over PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng*hr/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled PK Parameters for paclitaxel AUC (0-52), with the unit ng*hr/mL. AUC, or area under the concentration-time curve, is a pharmacokinetic measure that represents drug exposure across a specified time interval. It uses concentration measurements taken over time rather than relying on a single measurement. The interval notation is part of the registry's outcome title; the record does not give further explanatory detail about the interval.
The planned summary was the mean and standard deviation. The mean describes the central value of the observed measurements, while the standard deviation describes how spread out those measurements are around the mean. Both can help characterize exposure in the assessed group, but neither alone describes every participant's profile. The record lists sampling before dosing and at 1, 2, 3, and 4 hours after dosing on days 1, 2, and 3 at week 1 and week 4.
Pharmacokinetic outcomes are used to characterize how much drug exposure is observed under a specified regimen. This is a general explanation of the role of an AUC measure, not a conclusion about Oraxol. The registry identifies the endpoint and the intended summary, but the actual mean and standard deviation are not reported in the registry record. Consequently, the numerical exposure distribution and its precision cannot be assessed from the posted outcome information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a pharmacokinetic study, not a randomized efficacy comparison. Its primary outcome is paclitaxel AUC (0-52), in ng*hr/mL, summarized as a mean and standard deviation. The record specifies repeated sampling across dosing days at week 1 and week 4. However, it does not report the numerical mean or standard deviation. The endpoint is therefore identifiable, but the magnitude and variability of the measured exposure cannot be evaluated from the posted results.
The record reports 28 enrolled participants and says that 25 completed the two-period pharmacokinetic assessment. These counts indicate that the completed assessment population was not identical to the enrollment count, but the reasons for the difference are not reported in the registry record. It would be inappropriate to assume that every enrolled participant contributed to every outcome or to infer why any participant did not complete the assessment.
The absence of a comparator limits the kinds of conclusions the study can support. A single-group study can describe measurements and events among participants who received the intervention. It cannot, by design, estimate a randomized difference between Oraxol and another treatment. The registry lists response rate, progression-free survival, and overall survival as secondary outcomes, but numerical results for these outcomes are not reported in the registry record. No comparative benefit or lack of benefit can be concluded from their listing alone.
Precision also cannot be judged for the primary endpoint because the result and any confidence interval are not reported in the registry record. In general, a confidence interval gives a range of values compatible with an estimate under the statistical method used; its width conveys information about precision. A standard deviation describes variability among observations, which is different from uncertainty around an estimated mean. Neither quantity can be recovered from the outcome description alone.
The safety information is more numerical. The record lists 8 participants with serious adverse events among 28 at risk, 27 with other adverse events among 28 at risk, and 1 death. It also lists serious-event terms and percentages, including neutropenia at 10.7%. These are descriptive counts and event listings. The record does not state that the listed events were caused by Oraxol, and the counts do not provide a comparison with an untreated or alternative-treatment group. The registry does not report further context on event timing, duration, severity grading beyond seriousness, or attribution.
Planning illustrations based on an observed effect are distinct from observed trial results. The stated assumptions describe a hypothetical two-arm planning framework, including equal allocation and a normal approximation, while the actual study is single-group. Any such illustration is not observed power and does not establish what the study detected. The numerical planning outputs are not reported in the registry record. Overall, interpretation is constrained chiefly by the absence of numerical primary-endpoint results, the lack of a comparator, and limited reporting of analysis and missing-data details.
9. Statistical Methods Explained
What does the mean describe?
The registry says that the primary pharmacokinetic parameters were summarized using the mean and standard deviation. In general, a mean is a measure of the center of a set of observations: it combines the recorded values into one descriptive estimate. In this study, the planned mean concerns paclitaxel AUC (0-52), measured in ng*hr/mL. It would describe average exposure in the participants included in the relevant analysis, not necessarily every enrolled participant. The registry reports that 25 subjects completed the two-period pharmacokinetic assessment, but does not explicitly state that this was the analysis set for the primary outcome.
A mean is useful for concise description, but it does not show the full distribution. Different sets of measurements can share the same mean while having different patterns of variability. The registry does not report the actual mean, so the observed central value cannot be described. It also does not provide participant-level measurements from which the distribution could be assessed.
What does the standard deviation add?
In general, the standard deviation describes the spread of observations around their mean. A smaller standard deviation indicates observations tend to cluster more closely around the mean; a larger one indicates greater dispersion. It is a description of variation among measurements, not a confidence interval and not a measure of treatment effect. The registry specifies standard deviation as the dispersion measure for the primary outcome but does not report its value. Thus, the variability of measured AUC cannot be quantified from the record.
Pharmacokinetic measurements may vary across participants and across sampling times. A summary statistic compresses that information, so interpretation depends on knowing the analysis population and how measurements were handled. Those details are not reported in the registry record. The record identifies a sampling schedule, but does not describe any model or adjustment used to combine or interpret the resulting measurements.
Why does the sampling schedule matter?
In general, AUC uses concentration information across time to characterize exposure over a defined interval. Sampling at multiple times can capture more of a concentration-time profile than a single measurement. The registry specifies predose and post-dose sampling at 1, 2, 3, and 4 hours after dosing on days 1, 2, and 3 at week 1 and week 4. That schedule is part of the endpoint description; it does not, by itself, reveal the observed concentration values, the calculation procedure, or the resulting AUC estimates.
The record calls the outcome AUC (0-52), but does not explain further how that notation relates to the sampling schedule. No additional interpretation of the interval should be assumed. The primary result itself—the mean and standard deviation—is not reported in the registry record, so neither the size nor the precision of the exposure summary can be assessed.
What can a confidence interval say?
In general, a confidence interval expresses uncertainty around an estimate under a particular statistical procedure. A relatively narrow interval indicates more precision than a wider interval, while both the estimate and the interval are needed to understand the result. A confidence interval is not a range that contains every participant's value; individual observations can lie outside it. The registry does not report a confidence interval for the primary endpoint, and it does not report enough outcome statistics to reconstruct one. No interval should be inferred from the enrollment or completion counts alone.
A standard deviation and a confidence interval answer different questions. The former describes variability among observations; the latter describes uncertainty in an estimated quantity. In general, a study can have substantial participant-to-participant variability while still estimating a mean with some precision, or low variability with limited precision when information is sparse. Assessing either property requires the relevant outcome values and analysis details, which are not reported for the primary endpoint.
What does the single-group design allow?
The study is listed as single-group, with allocation not applicable and no masking. In general, a single-group design can characterize outcomes among people receiving an intervention, but it does not provide a concurrent randomized comparison. Without such a comparator, differences from another treatment cannot be estimated as randomized effects. Changes observed over time can also reflect factors other than the intervention. This design description is especially relevant when considering the secondary outcomes of response rate, progression-free survival, and overall survival: their listing does not itself establish a treatment effect, and their numerical results are not reported in the registry record.
The open-label designation means masking was not used. This is a design fact, not evidence that any outcome was biased. In general, lack of masking can matter for outcomes involving judgment or participant reporting, while pharmacokinetic laboratory measurements have different measurement characteristics. The registry does not describe laboratory procedures, assessor roles, or safeguards, so further claims about measurement bias are not possible.
How should planning calculations be read?
The registry's planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. For time-to-event outcomes, the assumptions refer to a total event count; for other outcomes, they refer to participants per arm. These are planning conventions, not features of the actual single-group design.
In general, a sample-size calculation estimates how much information a future design may need under specified assumptions. Its output depends on the assumed effect and statistical model. A planning calculation does not show that the completed study had a particular probability of detecting an effect; it is not observed power. The registry record does not report numerical sample-size outputs, and the actual enrollment of 28 should not be interpreted as validation of any hypothetical two-arm calculation.
The record lists no analyses. That means analysis results and detailed methods are not reported in the registry record; it does not establish which analyses may or may not have been performed outside the registry entry. Information on hypothesis tests, confidence intervals, covariate adjustment, handling of repeated measurements, and any interim analyses is not reported in the registry record. General statistical explanations cannot substitute for those study-specific details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and identifies paclitaxel AUC (0-52) as the primary outcome. Safety, response rate, progression-free survival, and overall survival are listed as secondary outcomes. The record reports no analyses. It does not state whether a multiplicity adjustment was used, whether a hierarchy among outcomes was prespecified, or how multiple measurements or comparisons were handled. Those details are not reported in the registry record.
In general, when a study examines multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable finding can increase if each test is interpreted separately without accounting for the set of tests. Methods to address this can include prespecified outcome hierarchies or statistical adjustments, but the appropriate approach depends on the design and objectives. No particular approach should be attributed to this study based on the outcome list alone. In this record, numerical outcome analyses and corresponding uncertainty estimates are not reported.
The record states that 28 participants were enrolled and 25 completed the two-period pharmacokinetic assessment. It does not explain reasons for noncompletion, identify the analysis population for each outcome, or describe how missing measurements were handled. It is therefore not possible to determine whether the primary analysis used all enrolled participants, only participants with completed assessments, or another defined set. The record also does not say whether missingness was treated as related to participant characteristics or outcomes.
In general, missing data can affect estimates when participants without measurements differ systematically from those with measurements. The direction and size of any resulting impact depend on why observations are missing and on the analysis method. Neither can be assessed from the enrollment and completion counts alone. No imputation method, sensitivity analysis, or protocol for incomplete pharmacokinetic profiles is reported in the registry record. The count of completed assessments should be read as a reported completion count, not as a complete account of the primary endpoint analysis.
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 |
|---|---|---|---|
| Oraxol (Oral Paclitaxel Plus HM30181) | 8 | 28 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Oraxol (Oral Paclitaxel Plus HM30181) | 1 of 28 |
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 |
|---|---|
| Oraxol (Oral Paclitaxel Plus HM30181) | 27 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 3 of 28 |
| Hepatitis acute | Hepatobiliary disorders | 1 of 28 |
| Pneumonia | Infections and infestations | 1 of 28 |
| Septic shock | Infections and infestations | 1 of 28 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 28 |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 28 |
| Deep vein thrombosis | Vascular disorders | 1 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oraxol (Oral Paclitaxel Plus HM30181) |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 16 of 28 |
| Neutropenia | Blood and lymphatic system disorders | 16 of 28 |
| Alopecia | Skin and subcutaneous tissue disorders | 12 of 28 |
| Nausea | Gastrointestinal disorders | 9 of 28 |
| Anaemia | Blood and lymphatic system disorders | 6 of 28 |
| Alanine aminotransferase increased | Investigations | 5 of 28 |
| Aspartate aminotransferase increased | Investigations | 5 of 28 |
| Vomiting | Gastrointestinal disorders | 4 of 28 |
| Neuropathy peripheral | Nervous system disorders | 4 of 28 |
| Decreased appetite | Metabolism and nutrition disorders | 4 of 28 |
Serious events with the highest arm-level rate: neutropenia (10.7%), hepatitis acute (3.6%), pneumonia (3.6%), septic shock (3.6%), femur fracture (3.6%).
The registry lists 28 participants at risk for serious adverse events and reports 8 affected participants. It lists 28 at risk for other adverse events and reports 27 affected participants. The death count is 1. These are descriptive safety figures for the Oraxol group, identified as oral paclitaxel plus HM30181. They do not, on their own, establish whether an event was caused by treatment or how the event rate compares with another treatment.
The listed serious-event terms include neutropenia at 10.7%, and acute hepatitis, pneumonia, septic shock, femur fracture, and infected neoplasm each at 3.6%. These are the percentages reported by the registry. The record does not report further detail about event timing, duration, severity grading, or attribution. It also does not say whether participants could contribute more than one event or whether the listed terms overlap. A participant count and an event-term percentage should not be assumed to represent the same kind of summary.
In general, serious adverse events are a safety category, while other adverse events are a separate recorded category. The figures are not a causal analysis. Because this was a single-group study, the safety counts have no concurrent control-group context in the registry record. The death count is reported without a stated cause or attribution; the record does not report whether the death was considered related to the intervention.
12. What the Result Does, and Does Not, Mean
The record identifies a focused pharmacokinetic question: how paclitaxel exposure, summarized by AUC (0-52), was characterized under the Oraxol regimen. It also identifies the planned summary statistics, mean and standard deviation, and describes the sampling times. These details clarify what the primary outcome was intended to measure. But the numerical primary result is not reported in the registry record. There is therefore no reported mean or standard deviation to interpret, and no basis in the posted results for describing the size or variability of exposure.
The study reports enrollment of 28 participants and completion of the two-period pharmacokinetic assessment by 25 subjects. This gives information about the study's reported participation and assessment completion, but the record does not give reasons for noncompletion or explain the population used for outcome analysis. It should not be assumed that the assessment completion count fully describes the primary analysis set.
The single-group design means that the reported outcomes, where available, describe experience in a group receiving Oraxol. There is no randomized control arm for estimating a comparative effect. The listed secondary outcomes include safety, response rate, progression-free survival, and overall survival, but numerical results for these outcomes are not reported in the registry record. Their inclusion does not establish that a particular clinical outcome occurred or that the intervention changed it.
The safety record reports serious adverse events in 8 participants, other adverse events in 27 participants, and 1 death, with several serious-event terms and associated percentages listed. These counts are relevant descriptions of events recorded in the study, but the record does not attribute them to treatment or provide a comparison group. They should not be read as proof of causation or as a comparative risk estimate.
In general, statistical interpretation requires both an estimate and information about its uncertainty, as well as a clear account of who was analyzed and how. The registry record does not report a confidence interval or analysis details for the primary endpoint. Consequently, the available entry establishes the intended question and some aspects of conduct and safety reporting, but it does not provide the numerical pharmacokinetic result needed to assess its magnitude or precision.
13. Why This Trial Matters Statistically
This study is statistically notable for distinguishing a pharmacokinetic description from a comparative treatment evaluation. The intervention was studied in a single group, and the primary endpoint was an exposure measure rather than a randomized difference in a clinical outcome. That distinction shapes what the design can estimate: it can characterize measurements in the assessed group, but it cannot isolate a comparative effect against a concurrent control.
The outcome definition is also important. The registry names paclitaxel AUC (0-52), specifies ng*hr/mL, identifies mean and standard deviation as summaries, and describes repeated sampling at defined post-dose times across two assessment periods. This allows readers to understand the intended measurement framework. At the same time, a clear endpoint definition is not a substitute for the result. Because the mean and standard deviation are not reported in the registry record, the central pharmacokinetic finding cannot be numerically evaluated.
The difference between enrollment and assessment completion highlights why analysis populations matter. The record states that 28 participants enrolled and 25 completed the two-period pharmacokinetic assessment, but does not describe the analysis set, missing-measurement handling, or reasons for noncompletion. These are essential details for understanding which participants contribute to a summary and how representative that summary may be of the enrolled group.
The safety counts illustrate another core statistical distinction: descriptive event reporting is not causal comparison. The record lists serious and other adverse events and a death, but supplies no control group or attribution details. Such counts can describe what was recorded in the treatment group, while leaving comparative risk and causality unanswered. The planning assumptions likewise should be separated from the design actually used; hypothetical two-arm sample-size illustrations are not observed power for this single-group study.
More broadly, this record shows why completeness of outcome reporting matters. Without numerical estimates, uncertainty measures, and analysis details, readers can identify the research question and design but cannot assess the primary estimate's magnitude or precision. Statistical interpretation depends not only on choosing a measure but also on reporting its result and how it was obtained.
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 for statistical interpretation is that the registry identifies the primary outcome but does not report its mean or standard deviation. The numerical value of paclitaxel AUC (0-52), its observed variability, and any uncertainty around it cannot be assessed. A confidence interval and analysis details are not reported in the registry record either.
The single-group design provides no concurrent comparator. As a result, the record does not support a randomized estimate of how outcomes differ from another treatment or control condition. The open-label designation indicates that masking was not used, but the registry does not describe outcome-assessment procedures or other measures relevant to potential assessment bias. No conclusions about the impact of masking can be drawn from the design label alone.
There is limited information about participants and analysis populations. The record reports 28 enrolled participants and 25 who completed the two-period pharmacokinetic assessment, but does not report why the counts differ, which participants were included in each outcome analysis, or how incomplete assessments were handled. Eligibility details and participant characteristics are not reported in the registry record. These omissions constrain assessment of who the results represent and how missing information may affect summaries.
The registry lists 14 outcome measures and no analyses. It does not report whether multiplicity was considered, which secondary outcomes have numerical results, or what statistical methods were used beyond the stated mean and standard deviation for the primary endpoint. The listed secondary outcomes cannot be interpreted as findings in the absence of their results.
Safety reporting is also limited: counts, event terms, and percentages are listed, but event timing, duration, attribution, and further severity details are not reported. The record gives one death without reporting its cause or relationship to treatment. Finally, the planning assumptions describe a hypothetical two-arm calculation, not the single-group study design, and no numerical planning outputs are reported. These limitations restrict both the outcome interpretation and the ability to evaluate the analysis process.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients — NCT03165955.
- Registry record last updated 2025-03-12; status last verified 2025-03.
- Results first posted 2020-07-08.
- 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
NCT03165955 is a completed phase 1, multicenter, open-label, single-group pharmacokinetic study sponsored by Health Hope Pharma. It enrolled 28 breast cancer patients for whom paclitaxel treatment was indicated. The intervention was Oraxol, with a stated regimen of 205 mg/m2 daily for three days weekly, for up to 16 weeks.
The primary outcome was paclitaxel AUC (0-52), measured in ng*hr/mL and summarized by mean and standard deviation. The record describes sampling before dosing and at 1, 2, 3, and 4 hours after dosing on days 1, 2, and 3 at week 1 and week 4. It reports that 25 subjects completed the two-period pharmacokinetic assessment, but the primary outcome values are not reported in the registry record.
Safety, response rate, progression-free survival, and overall survival are listed as secondary outcomes. The safety record reports 8 participants with serious adverse events, 27 with other adverse events, and 1 death among 28 at risk. No comparator arm is listed, and no analyses are reported.