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 An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer (NCT00570713), a randomized phase 2 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00570713 |
| Phase | Phase 2 |
| Condition | Pancreatic Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 155 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Morphotek |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients with previously untreated, unresectable stage 3 or 4 pancreatic cancer. The condition is listed as pancreatic cancer, and the study summary characterizes the disease as advanced. The primary endpoint description does not specify a separate analysis population.
Intervention
The intervention was MORAb-009 added to gemcitabine. The registry describes MORAb-009 administration at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle, then on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by intravenous infusion, with an initial dose of 1000 mg/m2 once weekly for up to 7 weeks. The complete treatment details are not reported in the registry record.
Comparator
The comparator was placebo added to gemcitabine. The placebo schedule is described as matching the MORAb-009 schedule, while gemcitabine was included in both groups. The available description of gemcitabine administration is incomplete, so further regimen details are not reported in the registry record.
Primary question
The primary question was whether overall survival, measured from randomization to death from any cause, differed between the group assigned MORAb-009 plus gemcitabine and the group assigned placebo plus gemcitabine. The registry reports median overall survival and 95% confidence intervals for each group. A hazard ratio, confidence interval for a between-group effect, and p value are not reported in the registry record.
3. Trial Design
This was a randomized, placebo-controlled phase 2 trial with a parallel-group design. Participants were assigned to MORAb-009 plus gemcitabine or placebo plus gemcitabine. The registry lists 155 participants enrolled, with 78 assigned to MORAb-009 plus gemcitabine and 77 assigned to placebo plus gemcitabine. The registry status is completed.
The registry’s masking field says triple masking, while the official title describes the study as double-blind. The specific people or roles covered by masking, and the reason for the difference in wording, are not reported in the registry record. The study start is listed as 2007-12, and primary completion as 2009-12.
The study summary describes participants as having previously untreated, unresectable stage 3 or 4 pancreatic cancer. Both groups received gemcitabine; the randomized contrast was the addition of MORAb-009 versus placebo. The MORAb-009 group’s description gives a dose of 5 mg/kg and a schedule beginning on Day 1 of Weeks 1 through 7 during the first cycle, then Day 1 of Weeks 1 through 3 of subsequent cycles. Placebo is described as administered on the corresponding schedule. The posted gemcitabine description gives an initial dose of 1000 mg/m2 by intravenous infusion once weekly for up to 7 weeks, but the regimen text is incomplete.
The primary outcome was overall survival. Progression-free survival and best overall response rate are listed as secondary outcomes. Details of random sequence generation, allocation concealment, site structure, eligibility criteria beyond the summary description, and the roles involved in masking are not reported in the registry record. The registry record does not give a fuller account of how treatment adherence or changes to assigned treatment were handled.
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 | MORAb-009 Plus Gemcitabine ('MORAb-009') | Placebo Plus Gemcitabine ('Placebo') |
|---|---|---|
| STARTED | 78 | 77 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 78 | 77 |
Reasons for not completing this period:
| Reason | MORAb-009 Plus Gemcitabine ('MORAb-009') | Placebo Plus Gemcitabine ('Placebo') |
|---|---|---|
| Adverse Event | 16 | 9 |
| Death | 7 | 7 |
| Lack of Efficacy | 40 | 49 |
| Physician Decision | 2 | 2 |
| Withdrawal by Subject | 3 | 3 |
| Discontinuation of Study by the Sponsor | 10 | 7 |
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 | MORAb-009 Plus Gemcitabine ('MORAb-009') | Placebo Plus Gemcitabine ('Placebo') | Total |
|---|---|---|---|---|
| Participants analysed | 78 | 77 | 155 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 78 | 77 | 155 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 64.3 (SD 12.7) | 65.8 (SD 10.3) | 65.0 (SD 11.5) |
| Sex: Female, Male: Female | Participants | 39 | 38 | 77 |
| Sex: Female, Male: Male | Participants | 39 | 39 | 78 |
| Race/Ethnicity, Customized: African American | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 3 | 3 |
| Race/Ethnicity, Customized: Hispanic | Participants | 6 | 4 | 10 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 69 | 67 | 136 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 1 | 2 |
| Region of Enrollment: North America | participants | 57 | 57 | 114 |
| Region of Enrollment: Europe | participants | 21 | 20 | 41 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over 1-21 Months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival was defined as the time in months from randomization to death from any cause. For participants alive at analysis, or without confirmation of death, the registry says survival time was censored at the date of the last study follow-up. The listed timeframe is 1-21 Months. The endpoint description says the primary endpoint was analyzed when 110 deaths had been observed.
Overall survival is a time-to-event endpoint: it uses the timing of deaths as well as whether a death was observed during follow-up. In general, this can retain information from participants whose follow-up ends before a death is recorded, by accounting for their observed time up to censoring. Censoring does not establish what happened after the last follow-up date; it marks the end of the recorded survival observation.
The registry reports median overall survival for each group, with a 95% confidence interval. A median describes the point in the observed survival distribution at which the estimated survival experience reaches its midpoint. A confidence interval expresses uncertainty around an estimate; it is not a range containing every participant’s survival time. The posted endpoint results do not include a reported hazard ratio or a confidence interval for the treatment contrast, so the group medians alone do not give a complete effect estimate for comparing survival over follow-up.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median overall survival of 6.5 months (95% confidence interval 4.5 to 8.1) for MORAb-009 plus gemcitabine and 6.9 months (95% confidence interval 5.4 to 8.8) for placebo plus gemcitabine. These are group-specific median estimates, not a direct estimate of the relative or absolute treatment effect. A hazard ratio, its confidence interval, and a p value for the between-group comparison are not reported in the registry record.
The confidence intervals describe uncertainty around the separate median estimates. They do not substitute for a confidence interval around a treatment contrast. Their ranges overlap, but that observation by itself is not a formal test of a difference between groups. The registry record does not provide the analysis needed to determine the statistical uncertainty of the direct comparison from the reported medians.
The endpoint description states that the primary endpoint was analyzed when 110 deaths had been observed. That statement describes the event point associated with the primary analysis; further information about the analysis date, follow-up distribution, or whether additional analyses were conducted is not reported in the registry record. The registry lists no analysis records. It also does not report a sponsor-reported hazard ratio or other inferential result for overall survival.
Because overall survival is a time-to-event outcome, the group medians do not show the complete pattern of event timing. The registry record does not provide survival curves, numbers at risk over time, or a reported hazard ratio. The summaries therefore support a limited description: the reported medians and their individual confidence intervals can be stated, but they do not by themselves establish the size or precision of a between-group effect.
The randomized comparison was MORAb-009 plus gemcitabine against placebo plus gemcitabine. This design makes the added study drug the intended contrast, but the numerical outcome summaries alone do not show whether any observed difference is compatible with chance or how precisely the contrast was estimated. No recalculated two-arm comparison is reported for this median time-to-event endpoint because the registry record indicates that values are missing or not estimable for such a comparison. The interpretation should therefore remain with the posted group-level results and the limitations of the registry’s reported analysis.
The listed secondary outcomes are progression-free survival and best overall response rate. Their names establish that they were included as outcomes, but numerical results for them are not included in the record. Their definitions, estimates, confidence intervals, and tests are not reported in the registry record. No conclusion about those outcomes can be drawn from the overall survival summaries.
9. Statistical Methods Explained
What does a median survival estimate describe?
Overall survival is a time-to-event measure. Each participant contributes information about the time from randomization until death, if death is observed, or until the last recorded follow-up when death is not confirmed. The median is a summary of the estimated survival distribution: it marks the time by which the estimate reaches its midpoint. It is not the average survival time, and it does not describe the survival time of every participant.
The registry reports median estimates of 6.5 months for MORAb-009 plus gemcitabine and 6.9 months for placebo plus gemcitabine. These values are summaries for the two groups separately. In general, a group median does not encode the full shape of the survival curve or the timing of events throughout follow-up. Different survival patterns can have the same median, so the medians alone are not a complete description of the time-to-event data.
How should confidence intervals be read?
The 95% confidence intervals reported for the medians are 4.5 to 8.1 for MORAb-009 plus gemcitabine and 5.4 to 8.8 for placebo plus gemcitabine. In general, a confidence interval communicates sampling uncertainty in an estimate under the assumptions of the analysis. It is not a guarantee that a particular interval contains the true value, nor does it describe the range of outcomes among individual participants.
These are intervals around each group’s median, not an interval around the difference between groups or a relative effect. A direct treatment comparison needs an estimate of the contrast and its uncertainty. The registry record does not report a hazard ratio, a confidence interval for that contrast, or a p value. Comparing separate confidence intervals by eye is not equivalent to a formal test of the randomized comparison.
What does censoring mean?
The endpoint definition says that participants alive at the time of analysis, and those without death confirmation, were censored at the date of their last study follow-up. In general, censoring means that an event time is not observed beyond a recorded point, while the participant’s observed time up to that point remains part of the analysis. It does not mean that the participant experienced no event after follow-up ended. The registry does not report further details about follow-up completeness or the handling of censoring beyond the endpoint description.
Time-to-event methods use information from both observed events and censored follow-up. Their interpretation depends on the analysis approach and assumptions, including how censoring relates to the event process. The statistical plan and additional assumptions used for the sponsor’s analysis are not reported in the registry record. The posted median estimates should therefore be read as reported summaries, without assuming unreported details about the model or estimation procedure.
Why is a hazard ratio not interchangeable with a median?
In general, a hazard ratio compares event rates over follow-up, according to the time-to-event model used. It is a relative measure and is not the same quantity as the ratio or difference between two medians. A hazard ratio can use the event-time information across follow-up, while a median gives a single point on each estimated survival distribution. The registry record identifies the outcome as time-to-event and indicates that only sponsor-reported hazard ratios are used for this type of comparison, but no sponsor-reported hazard ratio is present among the posted results.
Without a reported contrast and its uncertainty, the group-level medians cannot establish the statistical significance or precision of the comparison. The registry record also does not provide a reported test statistic or p value. No unadjusted comparison is recalculated from the medians because the record identifies values as missing or not estimable for a two-arm comparison of this median time-to-event endpoint.
What information does the event count add?
The endpoint description says the primary endpoint was analyzed when 110 deaths had been observed. In general, the number of events is important in time-to-event analyses because information about the comparison depends substantially on observed events, not only on the number enrolled. The statement does not, by itself, provide the statistical model, indicate whether the study had interim analyses, or explain any sample-size justification. Those details are not reported in the registry record.
The registry lists 155 participants enrolled and reports 78 in the MORAb-009 group and 77 in the placebo group for the outcome. These group counts describe the posted outcome entries, but the record does not identify the analysis population or explain whether every enrolled participant was included in the primary analysis. No assumption about the analysis set should be added beyond what the record states.
What can be concluded from the posted statistical information?
The direct numerical information consists of two median estimates and their 95% confidence intervals, along with the endpoint definition and event-trigger statement. General statistical interpretation distinguishes descriptive group summaries from an inferential comparison. The former describe the reported outcome in each group; the latter requires a contrast estimate and information about its uncertainty. Since the contrast statistics are not reported, the available results do not support a precise quantitative statement about the between-group effect. The registry record also gives no analysis records, so it does not provide a fuller account of the sponsor’s statistical findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists overall survival as the primary outcome and progression-free survival and best overall response rate as secondary outcomes. The record does not report a multiplicity strategy, such as whether or how statistical testing across outcomes was controlled. It also does not report numerical results or inferential tests for the secondary outcomes. Without those details, the secondary outcomes cannot be used to characterize the strength of evidence or the treatment contrast.
The registry lists no analysis records. It does not report a statistical analysis plan, the planned analysis populations, or whether analyses were adjusted for baseline characteristics. The primary endpoint description says the analysis was conducted when 110 deaths were observed, but does not report further details about analysis timing or any interim analyses. Those matters are not reported in the registry record.
For participants alive at analysis or without death confirmation, the endpoint description says survival was censored at the date of last study follow-up. This specifies the stated censoring rule, but the record does not explain the extent of missing follow-up, the completeness of death ascertainment, or whether any sensitivity analyses were conducted. It also does not report how other missing outcome data were handled.
The registry reports group counts for the primary outcome but does not identify a named analysis population, such as all randomized participants or a different subset. It is therefore not possible to determine from the record which participants were included in each analysis beyond the counts attached to the outcome. The specific methods used to address missing data, multiplicity, or analysis-set selection are not reported in the registry record.
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 |
|---|---|---|---|
| MORAb-009 Plus Gemcitabine ('MORAb-009') | 49 | 73 | 67.1% |
| Placebo Plus Gemcitabine ('Placebo') | 54 | 75 | 72.0% |
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 |
|---|---|
| MORAb-009 Plus Gemcitabine ('MORAb-009') | 73 of 73 |
| Placebo Plus Gemcitabine ('Placebo') | 75 of 75 |
Most frequent serious adverse event terms
| Event term | Organ system | MORAb-009 Plus Gemcitabine ('MORAb-009') | Placebo Plus Gemcitabine ('Placebo') |
|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 13 of 73 | 11 of 75 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 7 of 73 | 6 of 75 |
| Vomiting | Gastrointestinal disorders | 6 of 73 | 6 of 75 |
| Dehydration | Metabolism and nutrition disorders | 5 of 73 | 7 of 75 |
| Anaemia | Blood and lymphatic system disorders | 3 of 73 | 5 of 75 |
| Deep vein thrombosis | Vascular disorders | 1 of 73 | 7 of 75 |
| Nausea | Gastrointestinal disorders | 4 of 73 | 3 of 75 |
| Neutropenia | Blood and lymphatic system disorders | 4 of 73 | 3 of 75 |
| Abdominal Pain | Gastrointestinal disorders | 3 of 73 | 3 of 75 |
| Pneumonia | Infections and infestations | 2 of 73 | 4 of 75 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MORAb-009 Plus Gemcitabine ('MORAb-009') | Placebo Plus Gemcitabine ('Placebo') |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 35 of 73 | 38 of 75 |
| Anaemia | Blood and lymphatic system disorders | 32 of 73 | 36 of 75 |
| Fatigue | General disorders | 32 of 73 | 32 of 75 |
| Constipation | Gastrointestinal disorders | 34 of 73 | 27 of 75 |
| Anorexia | Metabolism and nutrition disorders | 26 of 73 | 25 of 75 |
| Oedema peripheral | General disorders | 27 of 73 | 23 of 75 |
| Thrombocytopenia | Blood and lymphatic system disorders | 25 of 73 | 25 of 75 |
| Abdominal pain | Gastrointestinal disorders | 27 of 73 | 20 of 75 |
| Vomiting | Gastrointestinal disorders | 23 of 73 | 24 of 75 |
| Diarrhoea | Gastrointestinal disorders | 22 of 73 | 23 of 75 |
Serious events with the highest arm-level rate: malignant neoplasm progression (17.8%), pulmonary embolism (9.6%), dehydration (9.3%), deep vein thrombosis (9.3%), vomiting (8.2%).
The registry records serious adverse events for 73 participants at risk in the MORAb-009 group and 75 at risk in the placebo group. Serious adverse events are reported as affecting 49 participants in the MORAb-009 group and 54 in the placebo group. These are counts of participants recorded as affected, not a direct measure of event severity beyond the serious-event classification, and they do not establish that the groups had comparable observation time.
The listed serious adverse event terms and percentages are malignant neoplasm progression, 17.8%; pulmonary embolism, 9.6%; dehydration, 9.3%; deep vein thrombosis, 9.3%; vomiting, 8.2%; and anaemia, 6.7%. The registry record does not explain the denominator for each listed percentage or whether participants could contribute more than one event. These entries should not be interpreted as an exhaustive list of all serious events.
Deaths are not reported in the adverse-event record. The entries do not provide enough detail to establish attribution, timing, duration, or whether a reported event led to treatment discontinuation. The percentages and counts describe posted safety information; they do not, on their own, establish a causal relationship to either study drug.
12. What the Result Does, and Does Not, Mean
The result establishes what the registry reports for the primary endpoint: median overall survival was 6.5 months (95% confidence interval 4.5 to 8.1) in the group assigned MORAb-009 plus gemcitabine and 6.9 months (95% confidence interval 5.4 to 8.8) in the group assigned placebo plus gemcitabine. These are descriptive estimates for each randomized group. They are not a direct estimate of the treatment effect.
The record does not report a hazard ratio, a confidence interval for a between-group effect, or a p value. Consequently, the posted median summaries do not quantify the relative comparison over follow-up or establish the precision of that comparison. The overlap of the two confidence intervals is not itself a test of the treatment contrast. No numerical claim about the size of an effect should be inferred by subtracting or dividing the reported medians.
The trial’s randomized, placebo-controlled design provides a framework for comparing the addition of MORAb-009 with the addition of placebo while gemcitabine is part of both regimens. However, the registry record’s limited statistical reporting prevents a full assessment of the primary comparison. The analysis population, statistical plan, and sponsor-reported comparative statistics are not reported in the registry record.
The listed secondary outcomes are progression-free survival and best overall response rate, but their results are not included in the posted outcome information. Nor does the record report a multiplicity approach. The primary endpoint results should not be treated as a substitute for results on those secondary outcomes.
Safety entries identify serious-event counts and selected terms, but do not establish that a particular event was caused by treatment. Overall, the posted information supports a factual account of group-level median survival and recorded serious adverse events. It does not provide enough comparative inference to determine the statistical strength or precision of the survival contrast, and it does not support a clinical recommendation.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the main outcome is time-to-event, yet the posted primary results consist of group-specific medians and confidence intervals rather than a reported treatment-effect estimate. Readers can see the survival summaries for each randomized group, but cannot recover the sponsor’s comparative analysis from those summaries alone. The distinction between describing each group and estimating the contrast is central to interpreting clinical trial results.
The endpoint definition also makes censoring relevant. Participants without a recorded death by the analysis time, or without death confirmation, contribute follow-up only through their last study follow-up date. In general, time-to-event methods use this partial follow-up rather than treating it as if the participant had a known event time. The record gives the censoring rule, while further details about the analysis assumptions and follow-up completeness are not reported.
The endpoint description identifies an analysis point tied to 110 observed deaths. This emphasizes that event information is important in survival analysis, but the record does not provide a statistical plan or sample-size justification. It would be inappropriate to infer those design details from the event count alone.
The registry’s two secondary outcomes also illustrate why outcome lists and outcome results are different kinds of information. Progression-free survival and best overall response rate are named, but their numerical estimates and inferential analyses are not reported. In addition, the registry does not state how multiplicity was handled. The available record therefore supports a narrower statistical interpretation than a complete trial report with comparative estimates, uncertainty measures, and analysis methods would allow.
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 primary outcome information is incomplete for interpreting the randomized comparison. The registry reports median overall survival and separate 95% confidence intervals, but no hazard ratio, confidence interval for the between-group contrast, or p value. It also provides no survival curves or numbers at risk over follow-up. These omissions limit assessment of the shape and precision of the comparative survival results.
The primary endpoint description states that analysis occurred when 110 deaths had been observed, but does not provide the statistical analysis plan, analysis timing, or any account of interim analyses. The registry does not report the analysis population, handling of protocol deviations, or whether the primary analysis included all randomized participants. The design details for randomization and allocation concealment are also not reported in the registry record.
Masking is described differently in the record: the masking field lists triple masking, while the official title says double-blind. The specific people covered by masking and any explanation for the differing descriptions are not reported. This prevents a more detailed account of how masking was implemented.
The secondary outcomes are listed but their results are not reported in the outcome information. No multiplicity procedure is given. For missing outcome information, the primary endpoint description states that survival was censored at last follow-up when participants were alive or death was unconfirmed, but the extent of missing follow-up and any sensitivity analyses are not reported.
Safety information gives counts and selected serious-event terms, but does not explain the denominator for each percentage, event attribution, or whether the listed terms are exhaustive. Death counts in the adverse-event record are not reported. These limitations mean that the registry record offers a restricted account of both comparative efficacy statistics and safety context.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer — NCT00570713.
- Registry record last updated 2015-09-09; status last verified 2015-09.
- Results first posted 2012-03-27.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed randomized phase 2 study compared MORAb-009 plus gemcitabine with placebo plus gemcitabine in previously untreated, unresectable stage 3 or 4 pancreatic cancer. The registry lists 155 participants enrolled and reports 78 in the MORAb-009 group and 77 in the placebo group for the primary outcome.
The primary outcome was overall survival, defined from randomization to death from any cause, with censoring at last follow-up for participants alive or without death confirmation. Median overall survival was 6.5 months (95% confidence interval 4.5 to 8.1) with MORAb-009 plus gemcitabine and 6.9 months (95% confidence interval 5.4 to 8.8) with placebo plus gemcitabine.
The registry does not report a hazard ratio, a confidence interval for the treatment contrast, or a p value. Progression-free survival and best overall response rate are listed as secondary outcomes, but their results are not reported. Serious adverse events were recorded for 49 of 73 participants at risk in the MORAb-009 group and 54 of 75 in the placebo group. Further analysis details, multiplicity methods, and analysis populations are not reported in the registry record.