This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients (NCT00856791), a na phase 2 study. The primary outcome is Progression Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00856791 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Traws Pharma, Inc. |
| Results posted | Yes |
2. Clinical Question
The registry record describes a phase II study of ON 01910.Na in patients with recurring platinum-resistant ovarian cancer. Its stated clinical question was whether treatment had an effect on progression-free survival, assessed over a six-month timeframe. The record does not report a progression-free survival result or an analysis estimating the treatment’s effect.
Population
Patients with recurring platinum-resistant ovarian cancer. The registry record lists ovarian cancer as the condition; it does not provide further participant characteristics in the primary outcome description.
Intervention
ON 01910.Na, administered intravenously as a 2-hour infusion. The regimen description specifies 3200 mg on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. The summary says treatment would continue for 6 or more cycles.
Comparator
There is no comparison group. The study is recorded as single-group, with allocation listed as NA, so the design does not provide a concurrent control arm.
Primary question
What is progression-free survival, measured in days from the first day of study drug dosing to documented disease progression or death, with a six-month timeframe?
This question is descriptive in a single-arm study: the observed course among treated participants could be characterized, but there is no randomized control group for estimating a treatment contrast. The registry record does not report the observed endpoint values, the number of participants included in an endpoint analysis, or a statistical estimate of progression-free survival. It therefore does not establish what the result was or how precisely it was estimated.
3. Trial Design
This was a phase II, single-arm study of ON 01910.Na. The registry lists allocation as NA and masking as none. With no control group, the design describes outcomes within the treatment group rather than a randomized comparison between treatments. The registry record lists Traws Pharma, Inc. as sponsor and the study status as completed.
The treatment description specifies intravenous ON 01910.Na at 3200 mg over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. The study summary says patients would be treated for 6 or more cycles. This describes the intended regimen; the registry record does not report how many participants received treatment, how many cycles they completed, or whether dosing changed during the study.
The registry record lists a start of 2009-03 and a primary completion of 2011-07. It lists enrollment as 1. That enrollment figure is not accompanied by an account of the number treated or included in the primary endpoint analysis. The record does not report reasons for any difference between enrollment and analysis populations.
Progression-free survival was the primary outcome, with a six-month timeframe. The outcome definition uses the number of days from first study-drug dosing to documented disease progression or death. Disease progression was assessed using RECIST guidelines, with the record describing progressive disease as at least a 20% increase in the sum of the longest diameter of target lesions relative to the smallest sum recorded since treatment began, or the appearance of one or more new lesions.
No protocol-level statistical analysis plan, sample-size justification, interim-analysis plan, or outcome-analysis methods are reported in the registry record. The record includes a secondary outcome of number of adverse events, but it does not provide a detailed secondary-outcome analysis.
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.
Overall Study
| Stage | ON 01910.Na |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
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 | ON 01910.Na |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | day |
| Endpoint classification | not reduced to a single comparison |
Progression-free survival is the time from the first day of study-drug dosing until documented disease progression or death. The registry specifies days as the unit and six months as the timeframe. In this study, progression was assessed using RECIST criteria, including a stated increase in target-lesion size or the appearance of new lesions.
General: a time-to-event endpoint uses both the timing of an event and whether that event occurred during follow-up. Progression-free survival combines progression and death as endpoint events, so either can end the measured interval. It is often used to describe how long participants remain alive without documented disease progression. Its interpretation depends on consistent assessment and follow-up, including how participants without a recorded event are handled.
The registry record does not report participant-level event times, a progression-free survival estimate, a confidence interval, or the number of participants with events. It also does not report how follow-up ended for participants without a documented progression or death. Accordingly, the endpoint definition is available, but the observed progression-free survival result and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and treatment regimen, but it does not report the primary endpoint result. There is no posted estimate of progression-free survival, no confidence interval, and no reported statistical test for that outcome. The record lists no outcome analyses. Consequently, the result cannot be described in terms of its magnitude, precision, or statistical compatibility with a comparison value.
The registry lists enrollment as 1. That figure is important context when reading the record, but it does not by itself establish the number who received treatment, completed follow-up, or contributed to the progression-free survival outcome analysis. Those analysis-population details are not reported in the registry record. The record also does not provide a participant-level event history from which the timing or frequency of progression or death could be described.
General: an estimate summarizes the observed data, while a confidence interval conveys the uncertainty associated with that estimate under a statistical model. A point estimate without an interval gives limited information about precision; without either, readers cannot assess how uncertain the primary endpoint estimate would be. A p-value, if reported, would address compatibility with a specified null hypothesis under assumptions, not the clinical importance of an effect. No p-value or test result for progression-free survival is reported in the registry record.
The single-arm design further limits interpretation. Without a concurrent comparison group, a within-group outcome cannot isolate the effect of the intervention from other influences on disease course or outcome assessment. A treatment effect relative to another treatment or to no treatment cannot be estimated from the design as recorded. This is a design limitation, not evidence for or against a treatment effect.
The adverse-event record lists 1 participant at risk for serious adverse events and 0 affected. It also lists 1 at risk for other adverse events and 1 affected. These sparse counts describe the registry entries, but do not provide detailed event types or a comparative safety analysis. Deaths are not reported as a numeric count in the adverse-event record.
Overall, the registry record supports a description of the study’s intended question, regimen, and design. It does not support a conclusion about the observed progression-free survival outcome. The absence of a reported result should not be interpreted as a result of zero effect, nor as evidence that an effect was present.
9. Statistical Methods Explained
General: statistical methods for a time-to-event outcome are designed to account for both the timing of events and the fact that some participants may not have an event recorded during their observation period. The endpoint in this study is progression-free survival, defined from first study-drug dosing to documented disease progression or death. The registry specifies a six-month timeframe, but does not report the analysis method used to summarize that endpoint.
What does censoring mean for a time-to-event outcome?
General: when an event has not been observed by the end of a participant’s available follow-up, the participant’s exact event time is unknown. Survival-analysis methods can retain the information that the participant remained event-free through the last known observation, rather than treating the follow-up time as if it were the event time. This is called censoring. Such methods rely on assumptions about how follow-up ends. The registry record does not describe censoring rules, reasons for loss to follow-up, or how participants without a recorded event were handled.
How can progression-free survival be summarized?
General: a Kaplan–Meier curve can estimate the probability of remaining event-free over time while accounting for censored observations. A median can be reported if the estimated event-free probability reaches the point required to define it during the relevant follow-up. A confidence interval can communicate uncertainty around a survival estimate or another summary. These are general options, not methods attributed to this study: the registry record does not state that a Kaplan–Meier method, a median, or a confidence interval was used or reported.
General: a hazard ratio is a relative measure of event rates over time and is usually interpreted in the context of a comparison. A log-rank test can compare time-to-event distributions between groups. Since this study is recorded as single-arm and has no concurrent comparator, these between-group methods do not supply a randomized treatment contrast for this design. The registry record does not report a hazard ratio, log-rank test, or other primary-outcome comparison.
What do the design and analysis record allow?
The registry identifies the study as phase II and single-group, with no masking. It lists allocation as NA. These registry entries describe the recorded design; they do not establish the detailed analysis plan. The registry record does not report an estimand, a prespecified model, covariate adjustment, an analysis population definition, or an approach to missing outcome data. The record also lists 0 analyses, so no primary-outcome analysis result is available there.
General: an analysis plan helps specify the outcome definition, population, handling of incomplete observations, statistical model, and interpretation before results are examined. Without those details, readers cannot determine whether an analysis followed prespecified procedures or how sensitive a result might be to alternative reasonable choices. Those plan details are not reported in the registry record.
How should planning illustrations be distinguished from results?
General: sample-size calculations describe how many participants or events might be needed under stated assumptions. They are planning exercises, not measurements of the study’s observed effect, and they do not establish whether a completed study had adequate precision. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The record describes these as an illustration based on the observed effect, with the effect to detect set as a stated fraction of that observed effect. Those assumptions do not match this study’s recorded single-arm design. No numerical planning result or observed primary outcome estimate is reported in the registry record, so no sample-size conclusion can be drawn from those assumptions.
General: observed power is not a substitute for an effect estimate and its uncertainty. A planning calculation should not be read as evidence that the study did or did not detect an effect. For time-to-event planning, the stated assumptions also refer to a total number of events; that planning convention does not supply the actual event count in this study. The registry record does not report a progression-free survival event count.
Statistical methods can clarify what the data estimate and the uncertainty around it, but they cannot compensate for an absent outcome analysis or a missing comparator. Here, the registry describes a defined endpoint and a single-arm design, but provides no reported primary-outcome estimate or method details with which to evaluate that endpoint statistically.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies progression-free survival as the primary outcome and number of adverse events as a secondary outcome. It lists 2 outcome measures, but does not report a statistical analysis for the primary or secondary outcomes. No multiplicity procedure, hierarchy of hypotheses, or adjustment for testing multiple outcomes is reported in the registry record. Without reported tests or estimates, it is not possible to assess whether multiplicity affected any interpretation.
The record does not report whether interim analyses were planned or conducted, or whether the primary analysis followed a prespecified statistical plan. Details of the analysis population are also not reported. Although the registry lists enrollment as 1, it does not state how many participants were treated, followed for the endpoint, or included in an analysis.
Missing-data handling is not reported in the registry record. In a time-to-event analysis, relevant details could include the last known follow-up for participants without a recorded event and how withdrawal or incomplete assessment was treated. The registry does not report those details, nor does it give reasons for missing or incomplete observations. It is therefore not possible to evaluate whether missing follow-up could have influenced a progression-free survival estimate.
These absences should be distinguished from evidence that no multiplicity, missingness, or interim monitoring issues occurred. The registry record simply does not report the relevant procedures or analysis details.
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 |
|---|---|---|---|
| ON 01910.Na | 0 | 1 | 0.0% |
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 |
|---|---|
| ON 01910.Na | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ON 01910.Na |
|---|---|---|
| Hypomagnesia | Metabolism and nutrition disorders | 1 of 1 |
| Constipation | Gastrointestinal disorders | 1 of 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 1 |
| Pain-right flank | Musculoskeletal and connective tissue disorders | 1 of 1 |
| Fatigue | General disorders | 1 of 1 |
| Nausea | Gastrointestinal disorders | 1 of 1 |
| Hematuria | Renal and urinary disorders | 1 of 1 |
The adverse-event record lists the ON 01910.Na group with 1 participant at risk for serious adverse events and 0 affected. For other adverse events, it lists 1 at risk and 1 affected. These are counts in the registry record and should be read as descriptive entries, not as comparative estimates of risk.
The record does not list serious adverse-event terms, so the event types are not reported in the registry record. The deaths entry is null; this means a death count is not reported there, not that the count can be interpreted as zero. The record also does not provide detailed event timing, severity grades, relationship to treatment, duration, or an account of how adverse events were collected.
General: adverse-event counts depend on the population assessed, follow-up, event definitions, and completeness of reporting. A count from a small recorded group cannot by itself establish how often an event would occur in a broader population or whether treatment caused it. With no comparison group and limited event detail, the registry entries do not support a comparative safety estimate or a detailed evaluation of adverse-event patterns.
12. What the Result Does, and Does Not, Mean
The record documents a phase II study of intravenous ON 01910.Na in recurring platinum-resistant ovarian cancer, with progression-free survival specified as the primary endpoint. The endpoint definition and treatment schedule are described, and the registry lists the study as completed. These details establish what the study set out to examine, but they do not provide the primary outcome result.
No progression-free survival estimate, event count, confidence interval, or statistical test is reported in the registry record. Therefore, the result does not show a quantified change in progression-free survival, and its precision cannot be assessed. The absence of an analysis is not evidence of no effect; it also cannot be used as evidence of benefit.
The study has no concurrent comparator. Even if a within-group outcome estimate were available, a single-arm design would not provide a randomized comparison to distinguish a treatment effect from other explanations for the observed outcome. The registry record contains no adjusted comparison or other causal estimate.
The enrollment figure and adverse-event counts also need cautious reading. Enrollment is listed as 1, but the record does not explain the analysis population or provide participant-level outcome information. The adverse-event entries list 0 affected for serious events and 1 affected for other events, each with 1 at risk; they do not give enough detail for a broad safety conclusion. A null death entry is not a reported count of zero.
In practical statistical terms, the registry record is informative about the study’s design and stated endpoint but not about its primary result. The missing outcome estimate, uncertainty measures, analysis details, and comparator prevent assessment of the magnitude or precision of any progression-free survival finding.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a registered research question and a reported statistical result. The registry specifies progression-free survival, its time origin, event definition, and assessment timeframe. Yet no analysis is listed, and no primary outcome estimate is reported. Knowing the endpoint definition is necessary for interpreting a result, but it cannot substitute for the result itself.
The single-arm design is also statistically important. It can describe outcomes in the treated group, but it does not create a concurrent estimate of what would have happened under another treatment or no treatment. That limits the causal interpretation of any within-group pattern, even if one were reported. Here, the absence of an outcome analysis adds a separate limitation: there is no estimate to characterize.
The record also shows why enrollment, event counts, and analysis populations should not be treated as interchangeable. It lists enrollment as 1 and provides adverse-event counts for participants at risk, but does not report how many participants contributed to progression-free survival analysis. The available safety entries therefore do not fill the gap in primary endpoint reporting.
For biostatistical interpretation, this record is a reminder to separate protocol information, observed data, and inferential claims. Design details describe how a study was organized; an estimate describes what was observed; and uncertainty measures indicate how precisely that estimate is known. The registry provides useful design and endpoint context, but does not report the estimate or its uncertainty. Statistical conclusions about progression-free survival are therefore not supported by the 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 principal limitation for interpreting this trial is that the registry record does not report a primary progression-free survival analysis. There is no estimate, event count, confidence interval, or test result. As a result, the magnitude and precision of the outcome cannot be evaluated.
The single-arm design provides no concurrent control group. It cannot support a randomized treatment comparison, and any within-group outcome description would be limited in its ability to separate treatment effects from other influences. The record does not report an external comparator or an adjusted comparison.
The registry lists enrollment as 1, but does not explain whether this represents the number treated, the number followed, or the number included in the endpoint analysis. It does not report participant characteristics, treatment exposure, completed cycles, follow-up duration by participant, or reasons for incomplete follow-up. The population contributing to the primary endpoint is therefore not described.
The analysis plan, missing-data procedures, interim-analysis details, and methods for calculating uncertainty are not reported in the registry record. The record also does not provide detailed adverse-event terms, while the deaths entry is null rather than a numeric count. These omissions limit interpretation of both efficacy-related outcomes and safety reporting.
Finally, the planning assumptions recorded for an illustration describe equal allocation between two arms, whereas the trial is recorded as single-arm. No numerical planning result or observed endpoint effect is reported. The illustration therefore does not establish the design’s precision or power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients — NCT00856791.
- Registry record last updated 2017-07-21; status last verified 2017-06.
- Results first posted 2013-01-08.
- 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
NCT00856791 is recorded as a completed phase II, single-arm study of ON 01910.Na in recurring platinum-resistant ovarian cancer. The regimen description specifies intravenous administration of 3200 mg over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle; the study summary says treatment would continue for 6 or more cycles.
The primary outcome was progression-free survival in days, defined from first dosing to documented progression or death, with a six-month timeframe. The registry record lists enrollment as 1 but reports no primary outcome analysis or estimate. The adverse-event entries list 0 affected for serious events and 1 affected for other events, each with 1 at risk; deaths are not reported as a numeric count.
The record does not report the statistical analysis plan, analysis population, or missing-data procedures. With no comparator and no posted primary endpoint result, the registry record does not support an estimate of the treatment effect or its precision.