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 Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer (NCT00334893), a na phase 2 study. The primary outcome is Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00334893 |
| Phase | Phase 2 |
| Condition | Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 74 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Participants had recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. The registry record reports enrollment of 74 participants. Platinum-resistant and platinum-sensitive disease appear as separate groups in the safety results, but the record does not give additional eligibility details or explain how these categories were defined.
Intervention
Participants received eribulin mesylate by intravenous infusion over 15 minutes on days 1 and 8. Treatment courses were scheduled to repeat every 21 days in the absence of disease progression or unacceptable toxicity. The record describes one treatment group and does not list another study intervention.
Comparator
There was no concurrent control group. The study is recorded as single-group, with allocation listed as not applicable and masking listed as none. The platinum-resistant and platinum-sensitive categories are disease groups in the posted safety results, not randomized treatment arms or like-for-like controls.
Primary question
The primary endpoint was the number of participants with an objective response, defined using RECIST v1.0 criteria for target lesions assessed by MRI. Overall response combines complete and partial response. The endpoint was assessed over a timeframe of up to a total of a year. The registry record does not report the observed number of participants with an objective response, so the primary clinical question cannot be answered from the posted outcome result.
3. Trial Design
This was a multicenter phase II study of eribulin mesylate in recurrent ovarian epithelial, fallopian tube, or peritoneal cancer. The registry record identifies the study as completed and reports enrollment of 74 participants. The recorded study dates are 2006-04 for the start and 2012-03 for primary completion.
The design is listed as single-group, with allocation not applicable and no masking. Participants were not assigned to eribulin or a concurrent control treatment in a randomized comparison. The platinum-resistant and platinum-sensitive groups reported in the safety results describe disease categories; they are not treatment arms. Differences between those groups therefore cannot be interpreted as estimates of a treatment effect relative to a control.
The treatment description specifies eribulin mesylate intravenously over 15 minutes on days 1 and 8, with courses repeating every 21 days unless disease progressed or toxicity became unacceptable. The registry record does not report the protocol’s detailed eligibility criteria, the number who began treatment, treatment exposure, or reasons for discontinuation.
The primary outcome was objective response, expressed as a number of participants and assessed using RECIST v1.0 criteria for target lesions by MRI. The stated timeframe was up to a total of a year. A toxicity profile was listed as a secondary outcome. Although the record lists two outcome measures, it reports no analysis count. Details of the statistical analysis plan, including any planned subgroup comparisons or handling of incomplete outcome assessment, are not reported in the registry record.
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 | Platinum Resistant Cohort | Platinum Sensitive Cohort |
|---|---|---|
| STARTED | 37 | 37 |
| COMPLETED | 36 | 37 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Platinum Resistant Cohort | Platinum Sensitive Cohort |
|---|---|---|
| Not Treated | 1 | 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 | Platinum-Resistant Cohort | Platinum-Sensitive Cohort | Total |
|---|---|---|---|---|
| Participants analysed | 37 | 37 | 74 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 22 | 26 | 48 |
| Age, Categorical: >=65 years | Participants | 15 | 11 | 26 |
| Age, Continuous | years | 61 (38 to 80) | 60 (45 to 77) | 60 (38 to 80) |
| Sex: Female, Male: Female | Participants | 37 | 37 | 74 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 37 | 37 | 74 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer., measured over up to a total of a year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with an objective response to eribulin mesylate. It uses RECIST v1.0 criteria for target lesions assessed by MRI: complete response means disappearance of all target lesions, and partial response requires a decrease of at least 30% in the sum of the longest diameters of target lesions. Overall response combines complete and partial responses.
This is a binary outcome at the participant level: a participant either meets the response definition or does not. Reporting a count can describe how many participants met the criteria, while a response proportion would relate that count to a defined analysis population. The registry record gives the endpoint unit as participants but does not report the observed response count, the analysis population, or a response proportion. It also does not report how participants without a post-baseline assessment were classified.
Objective response is used in cancer trials because it applies prespecified imaging criteria to tumor change. A response endpoint does not, by itself, describe how long a response lasts, whether disease remains controlled, or how participants feel or function. Those outcomes are distinct from the response count. The stated assessment timeframe was up to a total of a year, but the registry record does not report the timing or frequency of individual assessments.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study enrolled 74 participants and evaluated eribulin mesylate in a single-group phase II design. It does not report the numeric result for the primary endpoint: the number of participants with an objective response. Consequently, the posted record does not allow readers to determine the observed response count or how precise an estimate of response would be. A response rate, confidence interval, or comparison with another treatment is not reported in the registry record.
The design also limits what can be inferred. With no concurrent control group, outcomes observed during treatment cannot separate the contribution of the intervention from other explanations, such as the course of disease or differences in participant characteristics. The platinum-resistant and platinum-sensitive groups are not substitutes for a randomized control: they are disease categories in the safety results and may differ in ways that affect outcomes. The registry record does not report a comparative efficacy analysis between them.
The safety information gives counts of participants at risk and affected in serious and other event categories within the platinum-resistant and platinum-sensitive groups. It also lists percentages for selected serious adverse event terms. These data describe reported safety findings, but they do not establish comparative risk against an untreated or alternative-treatment group. The record does not report enough detail to determine whether event categories overlap, how long participants were observed for safety, or how the term-specific percentages were calculated.
Inferential results such as p-values and confidence intervals are not reported in the registry record. Without the primary response result and its analysis population, precision cannot be evaluated. The reported enrollment is not a substitute for the number analyzed for the endpoint. The record also does not state whether outcome data were missing or how missing assessments were handled.
Any sample-size illustrations should be read as planning calculations rather than observed evidence or achieved power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect expressed as a fraction of the observed effect. Those assumptions do not describe this single-group trial’s actual allocation. The registry record does not report the trial’s own sample-size justification or a numerical observed effect on which to base an interpretation.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: the endpoint counts participants meeting the objective response definition. A binary outcome requires a clearly specified rule for classifying each participant. Here, the registry description uses RECIST v1.0 criteria for target lesions assessed by MRI. Complete response is defined as disappearance of all target lesions; partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions. Overall response is the combination of complete and partial response.
What does the response count tell the reader?
A count is an absolute description of the participants recorded as responding. To understand how frequently response occurred, readers also need the relevant analysis population: for example, whether the denominator is everyone enrolled, everyone who began treatment, or only those with an evaluable assessment. The registry record does not report the response count or specify an analysis population. Therefore, a response proportion and its precision cannot be interpreted from the posted outcome information.
A confidence interval, in general, describes the uncertainty around an estimate under a statistical model and its assumptions. It is not reported for this primary outcome in the registry record. Without the estimate, the analyzed denominator, and an interval, the available record cannot show how narrowly or broadly the response experience is estimated. This is different from saying that no response occurred: the numeric result is not reported in the registry record.
Why does the design matter?
A single-group study can describe outcomes among participants who received the study treatment, but it lacks a concurrent randomized control for estimating a treatment contrast. Randomization, in general, helps balance measured and unmeasured participant characteristics between groups; that protection is absent when there is only one treatment group. Outcomes in a single-group study can therefore be described, but a direct causal comparison with another treatment cannot be made from this design. The resistant and sensitive disease categories do not create a randomized comparison.
Statistical tests and confidence intervals are most informative when the analysis question, model, outcome population, and handling of incomplete observations are clear. The registry record does not report an analysis count and does not provide the statistical analysis plan, p-values, confidence intervals, or details about missing outcome data. No particular model or inferential procedure can therefore be attributed to the trial from this record.
How should planning illustrations be read?
General sample-size calculations ask how many participants might be needed under specified assumptions to detect an effect with a chosen statistical criterion. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Such calculations are conditional on their assumptions; they are not evidence that a trial had a particular probability of success after it was conducted.
Those assumptions do not match the recorded single-group design, which has no equal allocation between two treatment arms. The record does not report the trial’s own sample-size justification. Any illustration based on an observed effect should also be distinguished from the trial’s primary evidence: the numeric primary response result is not reported in the registry record, so the basis for interpreting a numerical effect is absent from the posted outcome information. A planning illustration is not observed power, and it cannot fill in an unreported clinical outcome.
What do the safety summaries establish?
Counts of participants affected describe the number of people recorded in an event category, while event-term percentages describe a frequency according to a denominator and coding approach. In general, a participant may experience more than one event, so event counts and participant counts are not automatically interchangeable. The registry record presents serious and other event counts for the two disease groups and percentages for selected serious terms, but does not report the detailed analysis rules or term-specific denominators. Those values should be read as registry safety summaries, not as a randomized comparative estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists an objective response outcome and a toxicity-profile outcome, but does not report an analysis count. It does not describe whether one endpoint was formally designated as the sole confirmatory test, whether there were multiple planned analyses of response, or whether any adjustment for multiple testing was used. The absence of reported p-values also means there is no set of inferential tests in the record from which to assess multiplicity. It would be inappropriate to assume a particular hierarchy or correction procedure.
The primary endpoint description names the response criteria, unit, and timeframe, but the analysis population is not reported in the registry record. The record does not say how participants without an evaluable MRI assessment were handled, whether any assessments were missing, or whether missingness was related to disease status, toxicity, or treatment discontinuation. It also does not describe imputation or sensitivity analyses. These omissions matter because the classification and denominator can affect interpretation of a binary response outcome.
Details of the protocol’s statistical analysis plan, interim analyses, and prespecified subgroup analyses are not reported in the registry record. The platinum-resistant and platinum-sensitive safety groupings do not establish that a subgroup efficacy analysis was planned or conducted. No results should be inferred for unreported analyses.
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 |
|---|---|---|---|
| Platinum-Resistant Disease | 17 | 36 | 47.2% |
| Platinum-Sensitive Disease | 16 | 37 | 43.2% |
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 |
|---|---|
| Platinum-Resistant Disease | 16 of 36 |
| Platinum-Sensitive Disease | 19 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | Platinum-Resistant Disease | Platinum-Sensitive Disease |
|---|---|---|---|
| Neutrophil count decrease | Investigations | 10 of 36 | 12 of 37 |
| Leukocyte count decrease/white blood cell decrease | Investigations | 2 of 36 | 3 of 37 |
| Obstruction-GI-Colon | Gastrointestinal disorders | 1 of 36 | 3 of 37 |
| Thrombosis/thrombus/embolism | Vascular disorders | 4 of 36 | 0 of 37 |
| Abdominal Pain | Gastrointestinal disorders | 2 of 36 | 1 of 37 |
| Hyponatremia | Metabolism and nutrition disorders | 1 of 36 | 2 of 37 |
| Pain | Musculoskeletal and connective tissue disorders | 1 of 36 | 1 of 37 |
| Cardiac ischemia/infarction | Cardiac disorders | 1 of 36 | 0 of 37 |
| Death NOS | Reproductive system and breast disorders | 1 of 36 | 0 of 37 |
| Death-Disease progression | Reproductive system and breast disorders | 1 of 36 | 0 of 37 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Platinum-Resistant Disease | Platinum-Sensitive Disease |
|---|---|---|---|
| Neutrophil count decrease | Investigations | 14 of 36 | 18 of 37 |
| White blood cell decrease | Investigations | 11 of 36 | 10 of 37 |
| Lymphocyte count decrease | Investigations | 2 of 36 | 2 of 37 |
| Hypokalemia | Metabolism and nutrition disorders | 3 of 36 | 0 of 37 |
| AST/SGOT increase | Investigations | 0 of 36 | 2 of 37 |
Serious events with the highest arm-level rate: neutrophil count decrease (32.4%), thrombosis/thrombus/embolism (11.1%), leukocyte count decrease/white blood cell decrease (8.1%), obstruction-gi-colon (8.1%), abdominal pain (5.6%).
The safety results separate participants with platinum-resistant disease from those with platinum-sensitive disease. For platinum-resistant disease, the record reports 36 participants at risk and 17 affected in the serious-event category, alongside 36 at risk and 16 affected in the other-event category. For platinum-sensitive disease, it reports 37 at risk and 16 affected in the serious-event category, alongside 37 at risk and 19 affected in the other-event category. These are descriptive counts, not a randomized comparison. The record does not explain whether participants can appear in both categories or provide further detail on safety follow-up.
The listed serious adverse event terms include neutrophil count decrease at 32.4%, thrombosis/thrombus/embolism at 11.1%, leukocyte count decrease/white blood cell decrease at 8.1%, obstruction-GI-Colon at 8.1%, abdominal pain at 5.6%, and hyponatremia at 5.4%. The registry record does not report the denominator or calculation details for these term-specific percentages. They should not be treated as mutually exclusive categories or compared directly across disease groups without that information. These summaries describe reported events; they do not establish that the intervention caused each event or quantify risk relative to a control treatment.
12. What the Result Does, and Does Not, Mean
The record describes a phase II study in which eribulin mesylate was given to participants with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Its primary question concerned objective response assessed by MRI using RECIST v1.0 criteria. The record also reports safety summaries for serious and other events and lists selected serious adverse event terms.
The central limitation for interpreting the primary clinical outcome is that the numeric response result is not reported in the registry record. A reader therefore cannot determine how many participants met the response definition, what proportion of a defined analysis population responded, or how precise such an estimate would be. The missing result does not imply either benefit or lack of benefit; it means the posted record does not provide the primary outcome value needed to describe the study’s response findings.
The single-group design is also important. Without a concurrent control group, the study cannot provide a randomized estimate of how outcomes would differ under another treatment or no study treatment. The disease categories in the safety results do not supply that control. Even if outcomes were available for each category, differences between them would not by themselves identify a treatment effect.
The safety counts and percentages offer descriptive information about events recorded in the registry. They do not by themselves establish causation, comparative safety, or the overall balance of benefits and harms. The record does not report the term-specific denominators, detailed safety follow-up, or whether participants could contribute to multiple event categories.
In general, a clinical trial result is best interpreted together with its outcome definition, analysis population, missing-data approach, statistical uncertainty, and study design. Several of those details are not reported in the registry record. The posted information supports a description of the study and its recorded safety summaries, but not a numerical conclusion about the primary response endpoint or a causal treatment comparison.
13. Why This Trial Matters Statistically
This study illustrates why design and reporting details matter when interpreting a clinical trial. A phase II label and an objective-response endpoint identify the study’s broad purpose, but they do not replace the observed outcome result. The registry record gives a clear response definition based on RECIST v1.0 and MRI assessment, yet does not report the number of participants who met that definition. Without that value and its analysis population, neither the scale of the observed response experience nor its precision can be evaluated.
The single-group structure provides another important statistical lesson. A study can describe outcomes among treated participants, but without a concurrent control it cannot estimate a randomized treatment contrast. Disease-group labels in safety reporting do not function as treatment assignments. Treating them as controls would confuse a participant characteristic with an experimental comparison.
The record also shows why safety summaries need context. Counts and term-specific percentages can communicate which events were recorded, but interpretation depends on the denominator, observation period, event definitions, and whether categories overlap. Those details are not fully reported in the registry record. Percentages alone do not establish causation or comparative risk.
Finally, planning calculations are distinct from the results of a completed study. Illustrations based on assumptions about allocation and effect size do not show that a trial had adequate observed power, and they cannot resolve an unreported endpoint. The record does not report its own sample-size justification. Keeping descriptive results, inferential evidence, and planning assumptions separate is essential for a statistically sound reading.
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 consequential limitation in the registry record is the absence of the numeric primary response result. Although the endpoint definition and timeframe are stated, the record does not report the number of participants with an objective response, an analysis denominator, a response proportion, or an interval describing uncertainty. This prevents a quantitative interpretation of the principal outcome.
The single-group design has no concurrent randomized comparator. It can describe the treated group but cannot establish a causal difference relative to another treatment. The platinum-resistant and platinum-sensitive disease categories in the safety results are not treatment arms. The record does not provide additional eligibility criteria or explain how those categories were defined.
Important analysis details are also not reported in the registry record. These include the statistical analysis plan, the analysis population, handling of missing or unevaluable MRI assessments, any interim analyses, and whether subgroup analyses were planned. The record does not provide p-values or confidence intervals for the primary endpoint.
Safety interpretation is limited by missing detail on event follow-up, term-specific denominators, and whether participants could be counted in more than one event category. The posted safety summaries are descriptive and do not provide a controlled estimate of comparative risk. Finally, although planning illustrations are described, the trial’s own sample-size justification is not reported, and an illustration should not be mistaken for observed power or an outcome result.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer — NCT00334893.
- Registry record last updated 2017-11-29; status last verified 2017-10.
- Results first posted 2013-12-10.
- 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
The registry record describes a completed multicenter phase II, single-group study of eribulin mesylate for recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. It reports enrollment of 74 participants, a study start of 2006-04, and primary completion in 2012-03. Treatment was administered intravenously over 15 minutes on days 1 and 8, with courses repeated every 21 days in the absence of disease progression or unacceptable toxicity.
The primary outcome was the number of participants with an objective response by RECIST v1.0 criteria for target lesions assessed by MRI, over a timeframe of up to a total of a year. A toxicity profile was listed as a secondary outcome. The record includes safety counts for platinum-resistant and platinum-sensitive disease groups and percentages for selected serious adverse event terms. The numeric primary response result, analysis population, and detailed statistical analysis plan are not reported in the registry record.