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 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer (NCT00267020), a randomized phase 2 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00267020 |
| Phase | Phase 2 |
| Condition | Pancreatic Neoplasm |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 130 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with locally advanced or metastatic pancreatic cancer were eligible for the study. The registry describes the primary analysis population as the intent-to-treat population, including all randomized participants. The record does not report further eligibility details in the information available for this analysis.
Intervention
The intervention regimen combined gemcitabine with enzastaurin. The study was open-label, so masking was not used. The registry’s arm description does not provide additional details about how the treatments were administered.
Comparator
The comparator was single-agent gemcitabine. The study used randomized allocation and a parallel-group model. The registry record does not report further details about the allocation procedure.
Primary question
The primary outcome was overall survival, measured from randomization to death from any cause. The comparison asks how the observed median survival and its confidence interval differed between the two assigned regimens. The registry reports arm-specific medians but does not report a hazard ratio or another formal comparative estimate in the posted results.
3. Trial Design
This was a randomized, open-label phase 2 study with parallel treatment groups. It compared gemcitabine plus enzastaurin with gemcitabine alone in participants with locally advanced or metastatic pancreatic cancer. The registry lists enrollment as 130. It records the study start as 2005-12, primary completion as 2008-05, and status as completed.
The primary outcome was overall survival. The registry defines it as the duration from randomization to death from any cause, with observation extending up to 27.7 months. Participants who were alive at the cut-off date were censored at their last contact. The reported primary population is the intent-to-treat population, defined in the record as all randomized participants.
The registry reports 86 participants in the enzastaurin-plus-gemcitabine arm and 44 in the gemcitabine arm for the primary outcome. The unequal arm sizes are the posted analysis counts; the record does not explain the allocation ratio or reasons for any differences between enrollment and arm counts. Censoring counts are reported separately for each arm.
Secondary outcomes included response rate, progression-free survival, duration of response, quality-of-life change, relationships between steady-state drug levels and clinical outcomes, CA 19-9 concentration, and adverse events. The registry lists eight posted secondary outcomes. It does not report detailed statistical procedures, allocation-concealment methods, or a sample-size justification in the record analyzed.
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: Participant flow reports those participants who discontinued from study drug.
Overall Study
| Stage | Enzastaurin+Gemcitabine | Gemcitabine |
|---|---|---|
| STARTED | 86 | 44 |
| Received at Least 1 Dose | 82 | 39 |
| Per-Protocol Population | 81 | 38 |
| COMPLETED | 0 | 1 |
| NOT COMPLETED | 86 | 43 |
Reasons for not completing this period:
| Reason | Enzastaurin+Gemcitabine | Gemcitabine |
|---|---|---|
| Adverse Event | 22 | 5 |
| Death | 2 | 1 |
| Withdrawal by Subject | 17 | 7 |
| Physician Decision | 3 | 2 |
| Disease Progression | 39 | 25 |
| Unrelated Complication | 1 | 1 |
| Sponsor Request | 1 | 0 |
| Other | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Intent-to -treat (ITT) population: All randomized participants. Participants censored: Enzastaurin+Gemcitabine = 17; Gemcitabine = 11.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Intent-to-treat (ITT) population: All randomized participants.
| Characteristic | Unit | Enzastaurin+Gemcitabine | Gemcitabine | Total |
|---|---|---|---|---|
| Participants analysed | 86 | 44 | 130 | |
| Age, Continuous | years | 68.3 (39.6 to 86.7) | 64.1 (41.9 to 83.4) | 67.6 (39.6 to 86.7) |
| Sex: Female, Male: Female | Participants | 40 | 12 | 52 |
| Sex: Female, Male: Male | Participants | 46 | 32 | 78 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 9 | 3 | 12 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 77 | 41 | 118 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 69 | 35 | 104 |
| Race/Ethnicity, Customized: Black or African American | Participants | 7 | 5 | 12 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Hispanic | Participants | 9 | 3 | 12 |
| Region of Enrollment: United States | Participants | 86 | 44 | 130 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 - Fully Active | Participants | 36 | 16 | 52 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 1 - Ambulatory, Restricted Strenuous Activity | Participants | 43 | 25 | 68 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 2 - Ambulatory, No Work Activities | Participants | 7 | 3 | 10 |
| Body Surface Area (BSA) | square meter (m^2) | 1.8 (SD 0.24) | 1.9 (SD 0.21) | 1.8 (SD 0.23) |
| Diagnosis Stage: Stage IIA | Participants | 3 | 0 | 3 |
| Diagnosis Stage: Stage IIB | Participants | 4 | 2 | 6 |
| Diagnosis Stage: Stage III | Participants | 7 | 7 | 14 |
| Diagnosis Stage: Stage IV | Participants | 72 | 35 | 107 |
| Current Stage: Stage IIB | Participants | 1 | 1 | 2 |
| Current Stage: Stage III | Participants | 7 | 5 | 12 |
| Current Stage: Stage IV | Participants | 78 | 38 | 116 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over Randomization to the date of death from any cause up to 27.7 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures the time from randomization until death from any cause. It is commonly used in clinical trials because the event is clearly defined and reflects survival regardless of the specific cause of death. In this study, the registry states that participants alive at the cut-off date were censored at their last contact. Censoring means that a participant’s exact time to death was not observed during the available follow-up, while the participant’s observed time contributes information up to the last known contact.
The reported summary is the median overall survival for each randomized group, accompanied by a 95% confidence interval. A median is the time by which the estimated survival experience has reached the halfway point. It describes the center of the time-to-event distribution; it does not describe every participant’s experience or show the shape of survival over time.
The registry gives the observation timeframe as randomization to death from any cause up to 27.7 months. It reports that overall survival was censored at last contact for participants who were alive at the cut-off date. The record does not provide a comparative hazard ratio, a p-value, or a formal test result for overall survival. The arm-specific medians therefore describe the posted results, but do not by themselves quantify a treatment contrast or establish its precision as a comparative effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
Median overall survival was 5.6 months in the enzastaurin-plus-gemcitabine arm, with a 95% confidence interval from 4.2 to 6.9 months. In the gemcitabine arm, the median was 5.1 months, with a 95% confidence interval from 3.6 to 8.1 months. These are separate arm-specific estimates. The registry record does not report a hazard ratio, a p-value, or another formal comparison of overall survival between the regimens.
The confidence intervals communicate uncertainty around each median estimate. The gemcitabine arm’s interval is wider than the interval reported for the combination arm, indicating less precision in that arm’s median estimate. Such intervals do not show the range of individual survival times, and they do not establish the probability that a particular treatment effect is true. Comparing arm-specific intervals alone is not a substitute for a direct statistical comparison.
The registry reports 86 participants for the combination arm and 44 for the gemcitabine arm in the primary outcome population. It also reports censoring counts of 17 and 11, respectively. Censoring is part of time-to-event analysis: those participants contribute information through their last contact, but their later survival time is not observed in the record. The posted summary does not provide further detail about follow-up patterns or how censoring was assessed.
The numerical difference between the two medians should not be treated as an independently calculated treatment effect. The registry’s reported results do not include an adjusted or unadjusted comparative estimate, and no significance test is listed. A median is only one feature of the survival distribution; it does not reveal whether the relative survival experience was consistent throughout follow-up. A hazard ratio, if reported, would describe a different aspect of the comparison and would require its own estimate and uncertainty interval.
The study also lists response, progression-free survival, duration of response, quality of life, drug-level relationships, CA 19-9, and adverse events among its secondary outcomes. The existence of these outcomes does not supply their results. Detailed results for the secondary outcomes are not reported in the registry record analyzed here, apart from the listed adverse-event counts and serious-event terms. The posted survival summaries should therefore be read as descriptive arm-specific estimates rather than as a complete account of the treatment comparison.
In general, a confidence interval is useful for judging the precision of an estimate, while a formal comparative analysis addresses uncertainty in the contrast between groups. For this record, the arm-level medians and confidence intervals are available, but the comparative survival analysis is not. The posted results consequently support a description of the reported survival summaries, not a definitive conclusion about whether the regimens differ.
9. Statistical Methods Explained
Overall survival is a time-to-event endpoint: each participant contributes information about the time from randomization until death or until the last time survival status is known. Participants still alive at the cut-off do not have an observed death time within the available follow-up. The registry says their observations were censored at last contact. In general, a censored observation is not the same as a death or as a complete observation through the end of follow-up; it indicates that the event time is not known beyond the recorded contact.
The registry reports medians and 95% confidence intervals by randomized group. A median provides a central summary of the estimated time-to-event distribution. The confidence interval expresses statistical uncertainty around that estimate under the method used to construct it. It is not an interval containing a stated fraction of individual participants’ survival times. Nor does an arm-specific confidence interval directly give uncertainty for the difference between arms.
The posted estimates are 5.6 months, with a 95% confidence interval of 4.2 to 6.9 months, for enzastaurin plus gemcitabine, and 5.1 months, with a 95% confidence interval of 3.6 to 8.1 months, for gemcitabine. The record does not identify the procedure used to estimate the medians or construct their confidence intervals. It also does not post a comparative hazard ratio, confidence interval for a contrast, or p-value. Those missing comparative quantities cannot be recovered from the arm-specific summaries alone.
In general, a hazard ratio summarizes the relative event rate over time under a specified model. It is not the same quantity as a ratio of medians, and it should not be inferred from the medians. The registry’s statistical description indicates that time-to-event interpretation relies on sponsor-reported hazard ratios, but no such hazard ratio is included among the posted primary results available for this account. No conclusion about the hazard ratio or its precision can therefore be stated from the record.
The primary analysis population is identified as intent-to-treat: all randomized participants. This principle retains participants in the groups to which they were assigned, regardless of subsequent treatment exposure, when analyzed as randomized. The registry reports 86 participants in the combination arm and 44 in the gemcitabine arm for the primary outcome, and gives censoring counts of 17 and 11, respectively. It does not provide further detail about participant disposition, adherence, treatment changes, or the handling of other missing outcome information.
The record identifies the trial as randomized, open-label, and parallel-group. Randomization is intended to support a fair comparison by assigning participants to groups using a chance process, while a parallel design follows the assigned groups as separate treatment arms. Open-label means that masking was not used. These design labels do not establish that all potential sources of bias were eliminated. Details about the allocation sequence, concealment, and other safeguards are not reported in the registry record.
For general statistical interpretation, over-dispersion is relevant when observed variability exceeds what a chosen model expects. It can make model-based standard errors and confidence intervals too narrow if ignored. The posted primary outcome is a time-to-event median, and the registry record does not report an over-dispersion assessment or enough modeling detail to determine whether that issue arose. It would not be appropriate to infer a model adjustment from the outcome summary alone.
The record lists planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as a stated fraction of the observed effect. For time-to-event outcomes, those illustrations are described as using a total event count; for other outcomes, they use participants per arm. These are planning calculations, not observed trial results, and they are not observed power. The registry does not report a sample-size justification for the original trial, and the listed assumptions should not be mistaken for the trial’s own design plan.
In general, a two-sided significance level sets a threshold for a particular inferential procedure; it does not describe the probability that a result is true. Here, the record’s stated level pertains to planning illustrations, not a posted test of the primary outcome. No inferential result for the treatment comparison is reported, so the stated planning level cannot be used to claim statistical significance.
There are no posted analysis records in the registry data considered. This means that detailed analysis outputs beyond the reported summaries are not available in the record. It does not establish which analyses were or were not conducted outside the registry. The sponsor’s full statistical analysis plan, model specifications, and methods for handling multiplicity are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists overall survival as the primary outcome and lists secondary outcomes covering response, progression-free survival, duration of response, quality of life, drug-level relationships, CA 19-9 concentration, and adverse events. It reports eight posted secondary outcomes and nine outcome measures. With several outcomes and analyses of interest, multiplicity can matter: in general, conducting multiple statistical tests can increase the chance of at least one apparently noteworthy result unless the analysis plan addresses that issue.
The registry record does not report a multiplicity-adjustment procedure, a prespecified hierarchy among secondary outcomes, or a complete statistical analysis plan. It also lists no analysis records in the data used for this account. The absence of those details means the intended handling of multiple comparisons cannot be assessed from the registry record; it does not establish what analyses were performed elsewhere.
The primary population is identified as the intent-to-treat population, defined as all randomized participants. For overall survival, the registry reports censoring at last contact for participants alive at the cut-off date, with censoring counts of 17 in the combination arm and 11 in the gemcitabine arm. The record does not provide further missing-data procedures, descriptions of loss to follow-up, or sensitivity analyses for censoring.
The adverse-event risk sets differ from the primary outcome arm counts: the registry reports 82 at risk for the combination arm and 39 for gemcitabine in the safety figures. The record does not explain why these safety denominators differ from the primary outcome counts. The reasons should not be inferred from the posted summaries.
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 |
|---|---|---|---|
| Enzastaurin+Gemcitabine | 49 | 82 | 59.8% |
| Gemcitabine | 23 | 39 | 59.0% |
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 |
|---|---|
| Enzastaurin+Gemcitabine | 80 of 82 |
| Gemcitabine | 38 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | Enzastaurin+Gemcitabine | Gemcitabine |
|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 7 of 82 | 3 of 39 |
| Deep vein thrombosis | Vascular disorders | 5 of 82 | 5 of 39 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 7 of 82 | 2 of 39 |
| Anaemia | Blood and lymphatic system disorders | 4 of 82 | 1 of 39 |
| Nausea | Gastrointestinal disorders | 5 of 82 | 0 of 39 |
| Pain | General disorders | 2 of 82 | 3 of 39 |
| Abdominal pain | Gastrointestinal disorders | 4 of 82 | 0 of 39 |
| Diarrhoea | Gastrointestinal disorders | 4 of 82 | 0 of 39 |
| Vomiting | Gastrointestinal disorders | 4 of 82 | 0 of 39 |
| Cholangitis | Hepatobiliary disorders | 2 of 82 | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Enzastaurin+Gemcitabine | Gemcitabine |
|---|---|---|---|
| Fatigue | General disorders | 50 of 82 | 22 of 39 |
| Haemoglobin decreased | Investigations | 46 of 82 | 23 of 39 |
| Platelet count decreased | Investigations | 46 of 82 | 20 of 39 |
| Neutrophil count decreased | Investigations | 32 of 82 | 18 of 39 |
| Nausea | Gastrointestinal disorders | 35 of 82 | 13 of 39 |
| Leukopenia | Blood and lymphatic system disorders | 26 of 82 | 14 of 39 |
| Decreased appetite | Metabolism and nutrition disorders | 23 of 82 | 16 of 39 |
| Oedema peripheral | General disorders | 25 of 82 | 12 of 39 |
| Constipation | Gastrointestinal disorders | 24 of 82 | 11 of 39 |
| Diarrhoea | Gastrointestinal disorders | 25 of 82 | 10 of 39 |
Serious events with the highest arm-level rate: deep vein thrombosis (12.8%), dehydration (8.5%), pulmonary embolism (8.5%), pain (7.7%), nausea (6.1%).
The registry reports serious adverse events for 49 of 82 participants at risk in the enzastaurin-plus-gemcitabine group and 23 of 39 at risk in the gemcitabine group. For other adverse events, it reports 80 of 82 and 38 of 39, respectively. These are counts of participants affected with the corresponding denominators, as recorded. They do not describe event severity beyond the serious-versus-other classification, duration, timing, or whether an event led to treatment discontinuation.
The listed serious-event terms and percentages are deep vein thrombosis, 12.8%; dehydration, 8.5%; pulmonary embolism, 8.5%; pain, 7.7%; nausea, 6.1%; and hyperglycaemia, 5.1%. The registry summary does not identify these term percentages as arm-specific, so they should not be attributed to either treatment group. It also does not provide the event-level definitions or details needed to interpret recurrence or overlap between terms.
In general, adverse-event summaries describe events observed during a study; they do not by themselves establish that a treatment caused an event. The safety denominators differ from the primary outcome counts, and the registry does not explain the difference. The posted figures should therefore be read as recorded safety counts, without assuming why participants were included in each risk set.
12. What the Result Does, and Does Not, Mean
The posted results describe median overall survival and its confidence interval in each randomized group. The median was 5.6 months for enzastaurin plus gemcitabine and 5.1 months for gemcitabine alone. The confidence intervals indicate uncertainty around those separate estimates, and the interval for gemcitabine is wider. The registry does not report a formal comparative estimate or test for the primary outcome.
These summaries do not establish that one regimen improves survival, nor do they establish that the regimens are equivalent. A comparison of arm-specific medians is not a substitute for a direct analysis of the time-to-event data. The record does not provide the comparative hazard ratio, its confidence interval, or a p-value. Without those results, the degree of statistical uncertainty about the treatment contrast cannot be described from the posted primary outcome data.
Overall survival is measured from randomization to death from any cause, with living participants censored at their last contact at the cut-off date. That approach accommodates incomplete observation in time-to-event data, but the record does not provide enough information to assess the censoring pattern or additional follow-up details. The stated timeframe extends up to 27.7 months; it should not be interpreted as the same duration of observation for every participant.
The study was a randomized, open-label phase 2 comparison, and its primary analysis population was intent-to-treat. Those design features provide context for understanding the posted results, but they do not replace the missing comparative statistical output. The registry also lists secondary outcomes, but their results are not reported in the information, aside from the adverse-event summaries.
The appropriate statistical reading is therefore limited: the registry gives arm-specific survival estimates and safety counts, while leaving important comparative and methodological details unreported. These results are a record of the posted observations, not a complete basis for judging the size, precision, or cause of differences between the regimens.
13. Why This Trial Matters Statistically
This trial illustrates why a clinical-trial result should be read at the level of the estimand and the reported analysis, not only by comparing two summary values. Median overall survival is clinically interpretable as a time-to-event summary, but it does not fully describe the survival curves or quantify the relative event rate over time. A direct comparative estimate and its uncertainty are important for assessing the evidence about differences between randomized groups.
Here, the registry reports the medians and their 95% confidence intervals but does not report a hazard ratio, a confidence interval for a comparison, or a p-value. The arm-specific estimates can be described precisely as posted, but they cannot alone answer how precisely the treatment contrast was estimated. The wider confidence interval in the gemcitabine arm also illustrates that precision may differ across arm-level estimates.
The record additionally shows how censoring forms part of survival analysis. Participants alive at the cut-off were censored at last contact, and censoring counts are reported by group. Interpreting those counts fully would require information about follow-up and censoring patterns that the registry does not report.
Finally, this study has multiple listed secondary outcomes, while the registry record does not report a multiplicity strategy or detailed analysis plan. This limits assessment of how secondary findings should be interpreted as a group. Taken together, the trial is statistically informative as an example of why outcome definitions, analysis populations, uncertainty, censoring, and availability of comparative estimates all matter alongside the point estimates.
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 registry record provides arm-specific median overall survival estimates, but no comparative hazard ratio, confidence interval for a treatment contrast, or p-value. As a result, the magnitude and precision of the comparative survival effect cannot be assessed from the posted primary outcome summary alone. The record also does not state the method used to estimate the medians or construct their confidence intervals.
The stated observation period is randomization to death from any cause up to 27.7 months, with living participants censored at last contact at the cut-off date. Further details about follow-up duration, censoring patterns, and sensitivity analyses are not reported in the registry record. The arm-specific censoring counts are available, but they do not by themselves establish whether censoring was comparable or how it affected the estimates.
The registry identifies the design as randomized, open-label, and parallel-group, but does not report allocation-concealment details, the randomization procedure, or a full statistical analysis plan. The analysis population is described as intent-to-treat. Other details about treatment exposure, adherence, protocol deviations, and participant disposition are not reported in the record.
The registry lists multiple secondary outcomes, but their detailed results and the approach to multiplicity are not reported in the information used for this account. Safety counts are recorded with denominators that differ from the primary outcome counts, and the record does not explain why. The serious-event term percentages are not identified as arm-specific in the summary. These limitations constrain interpretation of both the comparative efficacy evidence and the safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer — NCT00267020.
- Registry record last updated 2020-08-31; status last verified 2020-08.
- Results first posted 2020-08-31.
- 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.
18. Record Summary
The registry describes a completed, randomized, open-label phase 2 parallel-group study of gemcitabine plus enzastaurin versus gemcitabine alone in locally advanced or metastatic pancreatic cancer. Enrollment is listed as 130, with the study start recorded as 2005-12 and primary completion as 2008-05.
The primary outcome was overall survival from randomization to death from any cause, with living participants censored at last contact at the cut-off date. The reported medians were 5.6 months for the combination and 5.1 months for gemcitabine alone. The record does not report a formal comparative survival estimate or test. Secondary outcomes include response, progression-free survival, duration of response, quality of life, drug-level relationships, CA 19-9, and adverse events. Detailed results for most secondary outcomes are not reported in the registry record analyzed.