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 Phase I Combination Ixabepilone + Cisplatin (NCT00832117), a na phase 1 study. The primary outcome is Participants Experiencing Dose Limiting Toxicity (DLT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00832117 |
| Phase | Phase 1 |
| Condition | Non Small Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | R-Pharm |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with advanced solid tumors; the registry lists non-small cell lung cancer as a condition. The stated primary-outcome population was all treated participants. The registry record does not give further eligibility details or a breakdown of participants by cancer type.
Intervention
Participants received ixabepilone in combination with cisplatin. The record describes an escalation and expansion group and lists dose combinations of Ixa 32 mg/m2 with Cis 60 mg/m2 and Ixa 32 mg/m2 with Cis 80 mg/m2 in the safety results.
Comparator
There was no randomized comparator. The registry identifies the study as single-group and gives allocation as NA. The dose groups are not like-for-like control groups: their participant characteristics, treatment context, or other determinants of outcome cannot be assumed to be comparable from this record.
Primary question
The primary outcome was the number of treated participants experiencing dose-limiting toxicity within the first 21 days of the first cycle. The study purpose was to identify the highest dose of ixabepilone that could be given with cisplatin without severe or life-threatening side effects. The registry does not report the primary outcome count or an analysis estimate.
This is a dose-finding question rather than a randomized test of whether the combination improves an outcome compared with another treatment. In an early-phase study, tracking toxicities during a defined period can inform whether a dose combination warrants further investigation. The registry also lists response and response duration outcomes for participants with non-small cell lung cancer, alongside adverse events and laboratory abnormalities. Those listed outcomes indicate areas of assessment, but their results are not reported in the registry record. The available record therefore describes the study question and selected safety counts, not a complete evaluation of the combination's safety or antitumor activity.
3. Trial Design
The registry identifies this as a Phase 1 study of ixabepilone in combination with cisplatin in subjects with advanced solid tumors. The design is listed as single-group, with no masking and allocation recorded as NA. Enrollment was 30. The study status is completed; the recorded start was 2009-05 and primary completion was 2011-01. R-Pharm is listed as the sponsor.
The arm description names an escalation and expansion group, but does not give further details about the sequence of dose levels, enrollment rules, or how participants were assigned to dose combinations. The safety results include two dose groups: Ixa 32 mg/m2 + Cis 60 mg/m2, with 24 participants at risk for the reported serious and other adverse-event counts, and Ixa 32 mg/m2 +Cis 80 mg/m2, with 5 at risk. The registry record does not explain the relationship between the arm label and these group-specific results.
Because the study was not randomized and has no control arm, the dose groups should not be treated as a randomized comparison. Differences in counts between them would not, on their own, establish that dose caused a difference in risk. Small group sizes also mean that a single participant's outcome can materially affect a count-based description. The record does not report a statistical comparison between dose groups.
The primary endpoint concerns dose-limiting toxicity within the first 21 days of the first cycle. Other listed outcomes include best response by RECIST, percentage with response, duration of response in participants with non-small cell lung cancer, adverse events, serious adverse events, deaths, discontinuations, and laboratory abnormalities. Although 7 outcome measures are recorded, the registry reports 0 analyses. Results for the primary endpoint and most listed outcomes are not reported in the registry record. The design information thus establishes the broad study structure, but not the detailed conduct or analysis plan.
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 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).
Overall Study
| Stage | All Enrolled Participants |
|---|---|
| STARTED | 29 |
| COMPLETED | 17 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | All Enrolled Participants |
|---|---|
| Death | 1 |
| Disease Progression | 11 |
Analysis population for the primary outcome, as defined in the registry: all treated participants
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 | Ixa 32 mg/m^2+Cis 60 mg/m^2 | 32mg/m^2+Cis 80mg/m^2 | Total |
|---|---|---|---|---|
| Participants analysed | 24 | 5 | 29 | |
| Age, Continuous | years | 64 (33 to 77) | 54 (30 to 61) | 63 (30 to 77) |
| Age, Customized: < 65 years | participants | 12 | 5 | 17 |
| Age, Customized: >= 65 years | participants | 12 | 0 | 12 |
| Age, Customized: < 50 years | participants | 3 | 2 | 5 |
| Age, Customized: >= 50 years | participants | 21 | 3 | 24 |
| Sex: Female, Male: Female | Participants | 10 | 2 | 12 |
| Sex: Female, Male: Male | Participants | 14 | 3 | 17 |
| Karnofsky Performance Status: 80 - Activity with effort; some signs of disease | participants | 9 | 2 | 11 |
| Karnofsky Performance Status: 90 - Normal activity; minor signs of disease | participants | 2 | 1 | 3 |
| Karnofsky Performance Status: 100 - Normal no complaints; no evidence of disease | participants | 13 | 2 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Participants Experiencing Dose Limiting Toxicity (DLT), measured over Within the first 21 days of first cycle.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of treated participants experiencing dose-limiting toxicity within the first 21 days of the first cycle. A dose-limiting toxicity, as defined in the registry, includes specified treatment-related gastrointestinal, nonhematological, blood-related, or recovery-delay events. The definition includes severe diarrhea despite adequate or maximal medical intervention or prophylaxis; other Grade 3 or greater nonhematological toxicity requiring removal from further study therapy; delayed recovery that postpones scheduled retreatment for more than 3 weeks; specified neutropenia; and specified thrombocytopenia or bleeding requiring platelet transfusion. The registry says grading follows the criteria described in another outcome measure.
In general, an early-cycle toxicity endpoint is used in dose-finding research to identify toxicities considered sufficiently serious to affect whether a dose is suitable for further study. A defined assessment window makes clear which period contributes to the endpoint. The endpoint is a count of participants meeting the toxicity definition, rather than a measure of tumor response or duration of survival.
The registry gives the endpoint definition and timing, but does not report the number of participants who experienced dose-limiting toxicity, a dose-specific estimate, or an uncertainty interval. It therefore does not allow readers to assess the observed primary outcome or how precisely it was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a study objective, design descriptors, a primary endpoint definition, and selected safety counts. It does not report the primary dose-limiting toxicity result or a statistical analysis of that endpoint. Consequently, the central dose-finding question cannot be answered from the posted primary-outcome results in this record. A described endpoint is not itself evidence about how often the endpoint occurred.
For the reported serious adverse-event counts, the Ixa 32 mg/m2 + Cis 60 mg/m2 group had 7 affected participants among 24 at risk, and the Ixa 32 mg/m2 +Cis 80 mg/m2 group had 2 among 5. These are descriptive counts from groups of different sizes, not estimates from a randomized comparison. The record does not report an adjusted comparison, an uncertainty interval, or a statistical test for these groups. The serious-event term list includes abdominal pain and neutropenic sepsis at 20.0% each, vomiting at 8.3%, and bacteraemia, nausea, and pneumonitis at 4.2% each. The record does not specify in the displayed term list how these percentages were calculated, so they should be read as registry-reported values rather than recalculated estimates.
For other adverse events, the record lists 24 affected participants among 24 at risk in the 60 mg/m2 cisplatin group and 5 among 5 at risk in the 80 mg/m2 cisplatin group. The category is broad, and the record does not give the event-level breakdown in these figures. These counts do not indicate how many events each participant had, their duration, or their clinical course.
The registry lists response outcomes for non-small cell lung cancer, but does not report their results. It also lists deaths as an outcome category in the safety measures, while the group-specific death entries are not reported in the registry record. Missing outcome results should not be interpreted as zero events or as evidence that an outcome was not assessed. In general, an absent result leaves the corresponding frequency or effect uncertain.
The design is single-group and nonrandomized, with no control arm. Thus, even complete descriptive outcome counts would not establish how outcomes compare with another treatment or what would have occurred without the combination. The record supports a limited reading of selected safety counts and study structure, but not a conclusion about comparative safety, response, or the optimal dose.
9. Statistical Methods Explained
What does a single-group design tell us?
A single-group study describes outcomes among participants who received the study treatment. It can be useful in early-phase research for characterizing tolerability and observing outcomes during dose escalation or expansion. It does not, by itself, provide a randomized estimate of what would have happened under a different treatment. Without a concurrent randomized control group, observed events may reflect the treatment, the underlying illness, other care, or a combination of factors. This is why counts in the two listed dose groups should not be read as a controlled treatment comparison.
The registry records allocation as NA, masking as none, and the model as single-group. These are design descriptors, not estimates of treatment effect. The record does not explain the procedures used to decide which dose a participant received, nor does it provide enough detail to assess whether the groups were similar at baseline.
How should event counts be understood?
A participant count records how many people in a defined group had an event, whereas an event count can include repeated occurrences in the same person. The posted serious and other adverse-event summaries are expressed as participants affected and participants at risk. They do not convey the number of recurrent events, their timing, severity beyond the category reported, or whether one participant experienced several different events.
In general, counts depend on both the number of participants observed and the time and criteria used to identify events. A count without a clearly specified observation period or a fuller event definition may have limited interpretability. The primary dose-limiting toxicity outcome does have a stated period—within the first 21 days of the first cycle—and a detailed definition. However, its result is not reported in the registry record.
Why does uncertainty matter?
In general, an estimate describes an observed pattern, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. Smaller samples usually leave more uncertainty around an estimate than larger samples. This matters especially when interpreting uncommon events: a small count can be compatible with a range of underlying event frequencies. The registry does not report confidence intervals or other uncertainty measures for the posted safety counts, so the precision of those counts cannot be assessed from the record.
A statistical test or interval would not remove the limitations of a nonrandomized design. It could quantify sampling uncertainty under its assumptions, but it could not make dose groups exchangeable or eliminate confounding. No inferential analysis of the listed dose groups is reported in the registry record.
What role does the endpoint definition play?
A prespecified endpoint definition determines which events count toward the outcome. The primary definition combines several types of treatment-related toxicity, including gastrointestinal toxicity, other nonhematological toxicity, delayed recovery, neutropenia, and thrombocytopenia or bleeding. Combining different events into one endpoint can make a summary useful for dose-finding, but it also means that the overall count may conceal which component drove the outcome. Because no primary result or component breakdown is reported, the contribution of individual toxicity types cannot be assessed.
The registry says the grades are defined in Outcome Measure 7, and lists adverse-event and laboratory-abnormality outcomes under CTCAE Version 3 criteria. The record does not provide a statistical analysis plan describing how these outcomes were summarized, how missing assessments were handled, or whether any adjudication process was used.
What can be inferred from the response outcomes?
The registry lists best response according to RECIST, percentage of participants with response, and duration of response in participants with non-small cell lung cancer. In general, response measures describe tumor changes under specified criteria, while duration of response concerns how long a response persists. These outcomes answer different questions from dose-limiting toxicity. They also need defined analysis populations and assessment procedures to interpret fully. Their results and detailed methods are not reported in the registry record.
The registry records 7 outcome measures and 0 analyses. This indicates that the record lists outcomes but does not present analysis entries. It does not establish that no analyses were conducted outside the registry record. The record also does not report an interim analysis plan, a sample-size justification, or a multiplicity strategy. Those design and analysis details should therefore be treated as not reported in the registry record, rather than inferred from the Phase 1 label or study objective.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | 24 | 0 | 0.0% | 0.0% to 14.2% | 0.0% to 13.8% | 0.1% to 13.7% |
| 32mg/m^2+Cis 80mg/m^2 | 5 | 2 | 40.0% | 5.3% to 85.3% | 11.8% to 76.9% | 11.8% to 77.7% |
R code and output
arm <- c("Ixa 32 mg/m^2+Cis 60 mg/m^2", "32mg/m^2+Cis 80mg/m^2")
n <- c(24, 5)
events <- c(0, 2)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Ixa 32 mg/m^2+Cis 60 mg/m^2 24 0 0.0 0.0 14.2 0.0 13.8 0.1 13.7
ARM 32mg/m^2+Cis 80mg/m^2 5 2 40.0 5.3 85.3 11.8 76.9 11.8 77.711. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes: the primary dose-limiting toxicity count, response measures, duration of response, adverse events, serious adverse events, deaths, discontinuations, and laboratory abnormalities. It records 7 outcome measures and 0 analyses. The record does not describe a multiplicity strategy, such as whether any outcome was designated as a formal confirmatory test or how interpretation would account for examining multiple outcomes. In general, when many outcomes are considered, the chance of at least one apparently unusual result can increase; a stated analysis plan helps readers understand how findings were selected and interpreted.
Missing-data procedures are not reported in the registry record. The record does not say how participants with incomplete follow-up, missed assessments, or unavailable laboratory results were handled for each outcome. It also does not state whether every enrolled participant received treatment or contributed to every analysis. The primary endpoint specifies all treated participants as its population, but the record does not give a count of treated participants for that endpoint or its result.
The safety entries include participants at risk for each dose group, but the record does not explain how that group-specific population was defined or whether observation duration was comparable. Death counts are not reported in the registry record. An absent count should not be interpreted as no deaths, and a missing outcome result should not be treated as a finding of no effect.
In general, transparent reporting of analysis populations and missing-data handling is important because exclusions and incomplete observation can affect descriptive estimates. The registry record does not provide enough information to evaluate these issues for the listed outcomes.
12. 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 |
|---|---|---|---|
| Ixa 32 mg/m2 + Cis 60 mg/m2 | 7 | 24 | 29.2% |
| Ixa 32 mg/m2 +Cis 80 mg/m2 | 2 | 5 | 40.0% |
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 |
|---|---|
| Ixa 32 mg/m2 + Cis 60 mg/m2 | 24 of 24 |
| Ixa 32 mg/m2 +Cis 80 mg/m2 | 5 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Ixa 32 mg/m2 + Cis 60 mg/m2 | Ixa 32 mg/m2 +Cis 80 mg/m2 |
|---|---|---|---|
| VOMITING | Gastrointestinal disorders | 2 of 24 | 0 of 5 |
| BACTERAEMIA | Infections and infestations | 1 of 24 | 0 of 5 |
| NAUSEA | Gastrointestinal disorders | 1 of 24 | 0 of 5 |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | 1 of 24 | 0 of 5 |
| BRONCHOPNEUMONIA | Infections and infestations | 1 of 24 | 0 of 5 |
| ABDOMINAL PAIN | Gastrointestinal disorders | 0 of 24 | 1 of 5 |
| CEREBRAL ISCHAEMIA | Nervous system disorders | 1 of 24 | 0 of 5 |
| NEUTROPENIC SEPSIS | Infections and infestations | 0 of 24 | 1 of 5 |
| CONFUSIONAL STATE | Psychiatric disorders | 1 of 24 | 0 of 5 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 1 of 24 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ixa 32 mg/m2 + Cis 60 mg/m2 | Ixa 32 mg/m2 +Cis 80 mg/m2 |
|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | 16 of 24 | 3 of 5 |
| FATIGUE | General disorders | 10 of 24 | 4 of 5 |
| ALOPECIA | Skin and subcutaneous tissue disorders | 8 of 24 | 3 of 5 |
| CONSTIPATION | Gastrointestinal disorders | 7 of 24 | 4 of 5 |
| NEUTROPENIA | Blood and lymphatic system disorders | 8 of 24 | 2 of 5 |
| VOMITING | Gastrointestinal disorders | 8 of 24 | 1 of 5 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 4 of 24 | 2 of 5 |
| ASTHENIA | General disorders | 5 of 24 | 1 of 5 |
| DIARRHOEA | Gastrointestinal disorders | 6 of 24 | 0 of 5 |
| DYSGEUSIA | Nervous system disorders | 5 of 24 | 1 of 5 |
Serious events with the highest arm-level rate: abdominal pain (20.0%), neutropenic sepsis (20.0%), vomiting (8.3%), bacteraemia (4.2%), nausea (4.2%).
The serious adverse-event figures are participant counts within the dose groups. For Ixa 32 mg/m2 + Cis 60 mg/m2, 7 of 24 participants at risk were reported as affected; for Ixa 32 mg/m2 +Cis 80 mg/m2, 2 of 5 were reported as affected. These figures describe the groups recorded in the registry and do not show how many separate serious events occurred or whether participants had multiple events.
The registry also lists serious-event terms with reported percentages: abdominal pain and neutropenic sepsis at 20.0% each; vomiting at 8.3%; and bacteraemia, nausea, and pneumonitis at 4.2% each. The record does not state the calculation basis for these term-specific percentages in the listed results. They should not be combined or directly compared with the group-level affected-participant counts without that information.
For other adverse events, the record lists 24 affected participants among 24 at risk in the first dose group and 5 among 5 at risk in the second. These are broad category counts, not a description of severity or number of events. The registry does not report the group-specific death entries. Differences between these small, nonrandomized groups cannot establish a dose effect, and the record does not report a comparative analysis.
13. What the Result Does, and Does Not, Mean
The record establishes that a Phase 1, single-group study investigated ixabepilone with cisplatin in people with advanced solid tumors, and that non-small cell lung cancer was among the listed conditions. Its primary question concerned dose-limiting toxicity during the first 21 days of the first cycle. The registry gives a detailed endpoint definition and selected safety counts for two dose groups.
However, the number of participants experiencing the primary endpoint is not reported in the registry record. Results for the listed response outcomes are also not reported. As a result, the record does not allow a reader to determine from the primary endpoint how many participants experienced a dose-limiting toxicity, or to assess the response outcomes described in the registry. The available serious and other adverse-event counts offer only a partial description of safety.
In general, a count among treated participants describes what was recorded in that study population; it does not establish that treatment caused the event. A single-group design lacks a randomized control comparison, and the two dose groups are not identified as randomized or otherwise comparable. Their counts should not be interpreted as evidence that one dose is safer or more hazardous than the other.
The record also does not report confidence intervals, formal statistical comparisons, missing-data procedures, an analysis plan, or a sample-size justification. Without these details and the missing primary and response results, the precision and completeness of the available evidence cannot be fully assessed. The study objective should not be mistaken for a reported finding: stating that a trial aimed to identify a tolerable dose does not reveal what dose was selected or how the endpoint results supported that decision.
Accordingly, the registry supports a description of the study design, endpoint, and selected event counts, but not a conclusion about comparative effects, response, or an optimal dose. Those questions are not answered by the results reported in the registry record.
14. Why This Trial Matters Statistically
This trial illustrates the distinction between a study question and a study result. The primary endpoint is defined in detail, including the toxicity types and the assessment period, but its observed count is not reported in the registry record. Without that count, the central dose-finding outcome cannot be evaluated from the posted primary result. Clear endpoint definitions are necessary for interpretation, but they do not substitute for reporting the outcome itself.
It also highlights why design determines what a statistical comparison can mean. A single-group study can describe events among participants receiving a combination, while a randomized control group is needed for a direct randomized comparison of outcomes under alternative treatment assignments. The two dose groups listed in the safety results do not become control groups simply because their doses differ. Their nonrandomized counts are descriptive, and the registry does not report a comparative analysis.
Small group sizes make clear, careful reporting especially important. Counts show how many participants were affected in each group, but the record gives no uncertainty intervals for those summaries. General statistical reasoning cautions that estimates from small samples can be imprecise, especially for less frequent events. Precision cannot be judged from a count alone.
Finally, this record demonstrates the limits of interpreting a list of outcomes without their results and analysis details. Response, duration of response, laboratory abnormalities, and other safety outcomes are named, but their results and methods are not reported. In biostatistical reading, absence of a result is not a null finding. It is a gap that limits what can be concluded from the registry record.
15. 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 registry record does not report the primary endpoint count, although the endpoint definition and assessment window are stated. It also does not provide results for the listed response outcomes, laboratory abnormalities, discontinuations, or the group-specific death entries. This limits assessment of both the main dose-finding question and the broader safety and activity outcomes.
The study is single-group and nonrandomized, with no masking. The record does not describe a randomized comparator, and the dose groups should not be treated as a like-for-like control comparison. It does not provide baseline characteristics or enough allocation detail to assess whether the groups differed in relevant ways.
The safety results list 24 participants at risk in one dose group and 5 in the other. These group sizes are small, and the record does not report uncertainty intervals or a formal comparison. The term-specific serious-event percentages are listed without a calculation basis in the available record. The safety summaries also do not describe recurrent events, timing, or event duration.
Further details are not reported in the registry record, including the sample-size justification, statistical analysis plan, handling of missing data, and multiplicity approach. The relationship between the escalation and expansion arm description and the two dose-group safety results is not explained. The record also does not report how outcomes other than the primary endpoint were defined or analyzed in detail. These omissions mean the posted information supports only a limited descriptive interpretation, not a complete evaluation of study conduct or results.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Phase I Combination Ixabepilone + Cisplatin — NCT00832117.
- Registry record last updated 2020-10-28; status last verified 2020-10.
- Results first posted 2012-03-27.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT00832117 is a completed Phase 1, single-group study sponsored by R-Pharm. The registry lists 30 participants enrolled and describes ixabepilone with cisplatin for advanced solid tumors, with non-small cell lung cancer listed as a condition. The recorded start was 2009-05 and primary completion was 2011-01.
The primary endpoint was the number of treated participants with dose-limiting toxicity within the first 21 days of the first cycle. The record lists two dose groups in its safety results and reports selected serious and other adverse-event counts. It does not report the primary endpoint result, response results, or a statistical analysis. The registry record therefore describes the study structure and selected safety findings but leaves the principal dose-finding outcome unreported.