Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer (NCT05979298), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS).

2. Clinical Question

The clinical question is framed as a randomized comparison of two regimens in patients with platinum-resistant ovarian cancer. The primary outcome is time from treatment start until progression or death, assessed over a stated timeframe of 2 years since treatment began. The registry’s description defines progression using lesion changes or the appearance of new lesions and refers to RECIST criteria. It does not report the number of patients who experienced progression or death in each group, nor the duration of follow-up for individual participants.

The reported medians describe the midpoint of the observed time-to-event distributions, not the outcome of every participant. The log-rank test compares the groups’ time-to-event experience across follow-up; its reported p-value is 0.03. That result is a statistical comparison, not a measure of the size or precision of a treatment effect by itself. The registry record does not report a hazard ratio or a confidence interval for the between-group comparison. It also does not describe the primary analysis population or how incomplete follow-up was handled.

3. Trial Design

This was a phase II, randomized, open-label, parallel-group clinical study. The registry lists an enrollment of 40 and records 20 participants in each of the two outcome groups. One group received gemcitabine alone; the other received gemcitabine with Elenagen. The record is marked completed. CureLab Oncology is listed as the sponsor.

The gemcitabine regimen is described as 1000 mg/m2 on days 1 and 8 every 3 weeks. In the combination group, gemcitabine was supplemented with Elenagen at 2.5 mg intramuscularly weekly. The registry does not provide further dosing or treatment-duration details. Although allocation is described as randomized, the method used to generate or conceal the allocation is not reported in the registry record. Masking is listed as none, so the study is open-label.

The recorded study start is 2019-11-15, and the primary completion date is 2023-12-30. The primary outcome is progression-free survival, measured in months and described as the median duration from treatment start to progression or death. The stated timeframe is 2 years since the start of treatment. Safety of Elenagen in combination with gemcitabine is listed as a secondary outcome. The registry record does not give a detailed protocol, treatment adherence information, participant flow, or a description of withdrawals and exclusions.

Randomization helps create a planned comparison between groups, but it does not by itself show whether the groups remained comparable throughout follow-up or whether the analysis preserved the randomized assignment. The record does not state which analysis population was used. As the study was open-label, participants and study staff were not masked according to the registry listing; the record does not explain whether endpoint assessment was independently masked. Those details matter when interpreting an outcome that involves judgments about disease progression.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Progression-free Survival (PFS), measured over 2 years since the start of treatment.

Progression-free survival (PFS) is the time from treatment start until disease progression or death, whichever occurs first. The registry defines progression by changes in target or non-target lesions or the appearance of new lesions, referring to RECIST criteria. The outcome is recorded in months, with the median as the reported summary, and the stated assessment timeframe is 2 years since treatment began.

A time-to-event endpoint retains information about when an event occurred, rather than reducing the result to whether an event happened by one chosen date. The median is the point in the estimated time-to-event distribution by which half of the group’s event times have occurred, subject to how censoring is handled. Censoring arises when the event has not been observed by the last available follow-up or when follow-up ends for another reason. The registry record does not describe its censoring rules or the method used to estimate the medians.

PFS is used in clinical trials to summarize the time until progression or death. It does not directly describe symptoms, quality of life, or survival after progression. The record reports median PFS of 2.8 months for gemcitabine and 7.2 months for the combination. Although the endpoint description lists interquartile range as its dispersion measure, the meaning of the accompanying lower and upper values is not specified in the registry record. For the combination group, an upper value is not reported.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a median time-to-event value describe?

A median time-to-event value marks the midpoint of the event-time distribution. For PFS, the event is progression or death. It is not the average time in the group, and it does not mean that each participant had an event at the median. The registry reports medians of 2.8 months for gemcitabine and 7.2 months for gemcitabine with Elenagen.

Time-to-event analyses can include participants whose event was not observed during their available follow-up. Their information is generally treated as censored at the last time they were known to be event-free, rather than as though an event occurred then. This approach depends on assumptions about censoring and follow-up. The registry record does not say how censoring was handled, how the medians were estimated, or how many events were observed in either group.

What does the log-rank test compare?

The sponsor reports a log-rank test for the comparison, with p = 0.03. In general, the log-rank test compares the observed timing of events between groups over the follow-up period. It is not simply a test of the two medians: it uses information about the event-time patterns across the follow-up. The test does not by itself quantify the magnitude of a difference or provide an interval estimate.

A p-value is calculated under a null hypothesis and the assumptions of the statistical procedure. In general, it describes how unusual a test result at least as extreme as the observed one would be if the null hypothesis and model assumptions held. It is not the probability that the null hypothesis is correct, nor does it measure the probability that an observed difference is due to chance. The registry does not report the test statistic or a hazard ratio. No unadjusted re-calculation is reported for this time-to-event comparison.

Why does uncertainty matter?

An estimate is more informative when accompanied by a measure of its precision. In general, a confidence interval describes a range of values compatible with data and a specified statistical procedure; it is not a guarantee that the true value lies inside that particular interval. For an effect estimate, such an interval can show whether the data are consistent with a broad range of effects. The registry record does not report a confidence interval for a between-group effect or a hazard ratio.

The record lists lower and upper values with the medians, but does not specify their meaning. It names interquartile range as the dispersion measure for the endpoint, while the combination arm has no upper value recorded. Without a clear label, these values cannot be confidently interpreted as confidence intervals, interquartile limits, or another summary. This limits how precisely the medians can be interpreted from the registry record.

What does over-dispersion mean in general?

For count outcomes, over-dispersion means that variability is greater than a simple model assumes. A model that ignores that extra variability may give standard errors that are too small and uncertainty that appears too narrow. This is a general statistical issue, not a reported feature of this study’s primary PFS analysis. The record identifies a time-to-event endpoint and a log-rank comparison, not a count model. No over-dispersion assessment is reported.

How should planning calculations be read?

Sample-size calculations based on an observed effect are planning illustrations, not observed trial results and not evidence that a study had a particular probability of detecting an effect. The assumptions stated for the planning illustration are a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is to report total events. Those are planning assumptions, not a description of the trial’s original design or its observed power.

The registry record does not report the trial’s own sample-size justification, planned power, or a detailed statistical analysis plan. It also does not report interim analyses or specify adjustment for multiple comparisons. The listed enrollment and group counts are observed registry entries, distinct from any illustrative planning calculation. They should not be used to infer whether the trial met a prespecified statistical target.

What can the reported information support?

The record supports a description of the two reported PFS medians, the sponsor’s log-rank p-value, and the trial’s broad randomized, open-label design. It does not support reconstruction of an effect estimate with a confidence interval, since no hazard ratio or corresponding interval is reported. Reconstructing such a result would require assumptions and data not in the registry record. Likewise, the listed median values and ambiguous bounds are not enough to recover the full time-to-event distributions.

Interpretation also depends on details such as the analysis population, censoring, event adjudication, and handling of missing follow-up. These are not reported in the registry record. General statistical explanations describe what methods mean; they do not establish which additional procedures were used in this study.

10. Analyses Reported by the Sponsor

The registry reports the sponsor’s log-rank comparison of the two groups, with p = 0.03. It does not report a hazard ratio or confidence interval. For this time-to-event endpoint, no recalculated comparative estimate is reported, so there is no independent recalculation to set alongside the sponsor’s test. The median values of 2.8 months for gemcitabine and 7.2 months for the combination describe each group separately and do not substitute for a relative effect estimate.

A log-rank p-value addresses evidence against the test’s null hypothesis under its assumptions; it does not quantify the size of the contrast or its precision. An estimated hazard ratio with an interval would provide different information, but neither is reported in the registry record. The lower and upper values listed with the medians are not clearly identified, so they cannot be used as a substitute for a reported confidence interval.

The posted result should therefore be read as the sponsor-reported log-rank finding together with the group medians, not as a fully specified effect estimate. If an unadjusted recalculation conflicted with a sponsor analysis, the sponsor’s own analysis would take precedence; no such recalculation is reported for this median-time endpoint.

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies PFS as the primary outcome and safety of Elenagen in combination with gemcitabine as a secondary outcome. It lists two outcome measures and one analysis. These details do not establish how many analyses were planned, whether additional comparisons were made, or whether the reported test was selected in advance. A multiplicity strategy, such as a prespecified adjustment or testing hierarchy, is not reported in the registry record.

Multiplicity matters when several outcomes, time points, subgroups, or analyses are tested. Repeated testing can increase the chance of at least one apparently unusual result if each test is treated as though it were the only one. This is a general statistical concern, not evidence that the study conducted unreported tests. The registry does not give enough information to assess whether multiplicity affected the interpretation of the log-rank p-value.

The primary endpoint description leaves the population field blank. The record gives group counts but does not specify whether the analysis followed an intention-to-treat principle, included only participants who received treatment, or used another analysis population. It does not report participant flow, exclusions after randomization, or reasons for missing outcome information. The handling of missing data and censoring is not reported in the registry record.

For PFS, incomplete observation is commonly handled through time-to-event methods that account for censoring, but the validity of that approach depends on how censoring occurs and is recorded. The registry does not state the censoring rules, provide event counts, or describe follow-up completeness. It also does not report an interim-analysis plan or a detailed statistical analysis plan. These gaps limit evaluation of whether all randomized participants contributed as intended and how robust the result is to missing information.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The posted safety figures show zero serious adverse events among 20 participants in the gemcitabine group and zero among 20 participants in the combination group. The record lists zero deaths in the gemcitabine group and one in the combination group. In the separate “other adverse events” category, it records 4 in the gemcitabine group and 7 in the combination group.

These counts should be read as the registry’s recorded figures, not as a complete account of safety. The record does not define the “other” category, state whether events were treatment-related, or give event types, severity grades, duration, or exposure-adjusted rates. It also does not explain how events were collected or whether the figures count participants with an event or event occurrences. No serious adverse-event terms are listed.

Zero recorded serious events does not establish that serious events are impossible or that the groups have identical safety profiles. With limited information about event definitions and follow-up, the counts do not support a detailed comparison of risk. The single death recorded in the combination group is a registry count; the record does not state its cause or relationship to treatment. These figures describe posted safety data and do not determine an individual treatment decision.

13. What the Result Does, and Does Not, Mean

The result describes a randomized, open-label phase II comparison in platinum-resistant ovarian cancer. The registry reports median PFS of 2.8 months with gemcitabine and 7.2 months with gemcitabine plus Elenagen. It also reports a sponsor-conducted log-rank comparison with p = 0.03. Together, these are the central posted statistical findings: separate group summaries and a test comparing time-to-event experience.

They do not establish the magnitude and precision of a relative effect. No hazard ratio or confidence interval for the comparison is reported. The median values alone do not describe the whole distribution, and the record does not clearly identify the bounds accompanying the medians. Event counts, censoring details, follow-up completeness, and the analysis population are also not reported. Those omissions make it difficult to assess the stability and uncertainty of the comparison.

The randomized design is relevant to a comparative question, while the open-label design and incomplete reporting of progression assessment require attention. The registry record does not say whether progression was assessed by masked reviewers or how the criteria were applied. It also does not report the method of randomization or allocation concealment. These details do not negate the reported findings, but they limit what can be concluded from the record alone.

The study result does not show that a regimen will have the same outcome in every patient or setting, and the registry record does not establish a causal explanation for the observed group comparison. It does not report outcomes beyond PFS, apart from the listed safety information, and does not describe quality of life or survival after progression. A log-rank p-value is not a clinical-importance measure and is not a substitute for an effect estimate with uncertainty.

The appropriate reading is therefore bounded: the registry records a difference in group medians and a log-rank p-value, in a small phase II randomized study with an open-label design. How precisely the underlying comparison is estimated, how missing follow-up was handled, and how broadly the findings apply cannot be determined from the registry record.

14. Why This Trial Matters Statistically

This trial illustrates why a time-to-event result should not be reduced to a single p-value. The registry provides two median PFS values and a log-rank p-value, but not a hazard ratio or confidence interval for the comparison. The medians offer an accessible summary, while the log-rank test evaluates event timing across follow-up. Neither alone supplies a complete account of effect size and precision.

It also highlights the importance of clearly labeling uncertainty. The endpoint lists interquartile range, but the values accompanying the medians are not identified clearly and one upper value is absent. Readers cannot safely interpret those bounds as confidence limits without knowing what they represent. Clear endpoint summaries and explicit interval definitions are essential to understanding how much uncertainty surrounds a result.

The study’s randomized design makes it relevant to a comparative clinical question, but details needed to judge the analysis are not reported: the analysis population, event counts, censoring rules, follow-up completeness, and handling of missing data. These are not minor technicalities for a time-to-event outcome. They affect how the comparison is constructed and how much information it contains.

The record also distinguishes the primary efficacy endpoint from the listed safety outcome, but does not report a multiplicity plan. With multiple outcomes or analyses, prespecified methods for interpreting results are important. The posted safety counts further show why definitions and context matter: event categories, attribution, and collection methods are not described. Statistically, the trial is a useful example of what can be read from registry results—and how much remains uncertain when key analysis details are absent.

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.

Several trial-specific reporting gaps constrain interpretation. The registry describes the study as randomized but does not state the sequence-generation method or allocation concealment procedure. It lists no masking, and it does not clarify whether progression was assessed independently or by assessors unaware of group assignment. Since PFS depends on identifying progression, the assessment process is relevant.

The record does not report the analysis population, participant flow, withdrawals, exclusions, event counts, censoring rules, or completeness of follow-up. It states a timeframe of 2 years since treatment start but gives no individual follow-up information. These omissions make it difficult to assess how much information underlies the medians and log-rank test or whether missing observations could affect the comparison.

Although the endpoint identifies interquartile range as a dispersion measure, the additional lower and upper values are not explained, and an upper value is absent for the combination group. No hazard ratio or confidence interval is reported. The registry also does not provide the test statistic, detailed statistical plan, multiplicity approach, interim-analysis information, or the trial’s sample-size justification. Planning illustrations based on an observed effect should not be mistaken for the design rationale of this study.

Safety reporting is similarly limited: the record does not define the other-adverse-event category, identify event types, describe severity or attribution, or clarify whether counts represent participants or event occurrences. The cause and treatment relationship of the recorded death are not stated. The registry’s enrollment and outcome group counts are not a substitute for a participant-flow account.

Finally, the available record concerns one phase II study in the stated population and regimen. It does not provide results for other clinical outcomes or sufficient detail to determine the applicability of the findings beyond this study.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer — NCT05979298.
• Registry record last updated 2026-08-24; status last verified 2026-05.
• Results first posted 2026-08-24.
• 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.

19. Record Summary

The registry record describes a completed, randomized, open-label phase II parallel-group study sponsored by CureLab Oncology. It lists enrollment of 40, with 20 participants in each outcome group. Participants received gemcitabine alone or gemcitabine with Elenagen. The recorded study start is 2019-11-15 and the primary completion date is 2023-12-30.

The primary outcome is median PFS in months, measured from treatment start to progression or death, within a stated timeframe of 2 years. The posted medians are 2.8 months for gemcitabine and 7.2 months for the combination. The sponsor’s log-rank comparison has p = 0.03. No hazard ratio or confidence interval for the comparison is reported. Safety of the combination is listed as a secondary outcome; posted serious-event counts are zero in both groups, with other adverse-event counts of 4 and 7 and deaths of zero and one, respectively.

Important analysis details—including the analysis population, missing-data handling, censoring, and the meaning of the values accompanying the medians—are not reported in the registry record.