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 0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer (NCT00771953), a randomized phase 2 study. The primary outcome is Progression Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00771953 |
| Phase | Phase 2 |
| Condition | Lung Cancer, Non Small Cell Lung Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 109 |
| Arms in the primary outcome | 4 |
| Lead sponsor | University of Maryland, Baltimore |
| Results posted | Yes |
2. Clinical Question
Population
People with Stage IIIb non-small cell lung cancer with pleural effusion or Stage IV non-small cell lung cancer. The registry record lists lung cancer and non-small cell lung cancer as conditions. Enrollment was 109.
Intervention
Apricoxib in combination with either docetaxel or pemetrexed. The listed apricoxib regimen was 400mg once a day.
Comparator
Placebo once a day in combination with either docetaxel or pemetrexed. The four posted groups pair each study drug option with its corresponding chemotherapy option.
Primary question
Does the posted progression-free survival differ between apricoxib-plus-chemotherapy groups and placebo-plus-chemotherapy groups? The endpoint is measured from randomization to the first date recurrent or progressive disease is objectively documented.
The trial addresses the activity of adding apricoxib to one of two chemotherapy regimens, rather than comparing apricoxib alone with placebo alone. The posted results separate the apricoxib and placebo groups by chemotherapy backbone: apricoxib plus docetaxel versus placebo plus docetaxel, and apricoxib plus pemetrexed versus placebo plus pemetrexed. That structure matters for interpretation because the registry presents four groups, not a single pair of pooled treatment groups.
The primary objective in the registry record is to assess anti-tumor activity through progression-free survival. The available outcome is a median for each group with a 95% confidence interval. The registry record does not post a treatment-effect estimate or inferential comparison for these groups. The question can therefore be framed from the intended randomized comparison, while the posted numerical results should be read as group-level summaries rather than a complete statistical test of the treatment question.
3. Trial Design
This was a randomized, double-blind, placebo-controlled, multicenter phase 2 study with a parallel-group model. The registry lists University of Maryland, Baltimore as sponsor and enrollment of 109. The status is completed. The recorded start was 2008-11 and primary completion was 2012-05.
The intervention structure had four groups: apricoxib plus docetaxel, placebo plus docetaxel, apricoxib plus pemetrexed, and placebo plus pemetrexed. Apricoxib was listed as 400mg once a day; placebo was listed as once a day. The chemotherapy intervention is described as docetaxel or pemetrexed, but a dose or schedule for either chemotherapy drug is not reported in the registry record.
Randomization and double masking are features of the design that can reduce some forms of systematic differences and assessment bias. The registry does not report the allocation ratio, randomization method, concealment procedure, or details of who was masked. It also does not report whether randomization was stratified by chemotherapy option. Those design details should not be inferred from the fact that the trial was randomized and double-blind.
The posted progression-free survival group sizes are 17.0 for apricoxib plus docetaxel, 20.0 for placebo plus docetaxel, 19.0 for apricoxib plus pemetrexed, and 16.0 for placebo plus pemetrexed. These are the group counts accompanying the endpoint results, not a reconciliation of all randomized participants. The reason the counts accompanying the endpoint results differ from overall enrollment is not reported in the registry record. Analysis populations and participant flow are also not reported.
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: 110 patients started a 5 day run in period with 400mg apricoxib. 7 did not complete due to AEs, and 23 did not have at least 50% drop in PGE-M (randomization requirement). Of the remaining 80, 2 withdrew, 2 were ineligible by physician discretion, 1 died and 3 had progressive disease. Thus, 72 patients were randomized.
Overall Study
| Stage | Apricoxib Plus Docetaxel or Pemetrexed | Placebo Plus Docetaxel or Pemetrexed |
|---|---|---|
| STARTED | 36 | 36 |
| COMPLETED | 26 | 26 |
| NOT COMPLETED | 10 | 10 |
Reasons for not completing this period:
| Reason | Apricoxib Plus Docetaxel or Pemetrexed | Placebo Plus Docetaxel or Pemetrexed |
|---|---|---|
| Adverse Event | 5 | 3 |
| Death | 2 | 2 |
| Progression before active Tx | 1 | 2 |
| Sponsor decision | 1 | 0 |
| Other complicating disease | 1 | 0 |
| Withdrawal by Subject | 0 | 3 |
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 | Apricoxib Plus Docetaxel or Pemetrexed | Placebo Plus Docetaxel or Pemetrexed | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 36 | 72 | |
| Age, Customized | years | 62 (42 to 87) | 66 (49 to 76) | 64 (42 to 87) |
| Sex: Female, Male: Female | Participants | 16 | 16 | 32 |
| Sex: Female, Male: Male | Participants | 20 | 20 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival, measured over From the date of randomization until the first date that recurrent or progressive disease is objectively documented..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is progression-free survival, reported as a median in days. Its timeframe begins at randomization and ends at the first date recurrent or progressive disease is objectively documented. For this endpoint, progression was assessed using Response Evaluation Criteria In Solid Tumors Criteria, RECIST v1.0. The registry description defines progression as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
In general, a time-to-event endpoint summarizes how long participants remain without the specified event. A median time is the point at which the estimated event-free experience reaches its midpoint; it is not an average duration and does not describe every participant's course. Time-to-event methods can also accommodate follow-up that ends before an event is recorded, but the registry record does not describe how censoring was handled for this analysis.
Progression-free survival is used in general to characterize the time until documented disease progression in a clinical study. Its interpretation depends on how progression is defined and assessed, and on follow-up and analysis procedures. The registry record supplies the endpoint definition and RECIST criteria, but details such as assessment frequency, independent review, and handling of death are not reported.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival was 75.0 days for apricoxib plus docetaxel, with a 95% confidence interval from 47.0 to 104.0 days. For placebo plus docetaxel, the median was 97.0 days, with a 95% confidence interval from 48.0 to 216.0 days. For apricoxib plus pemetrexed, the median was 103.0 days, with a 95% confidence interval from 62.0 to 225.0 days. For placebo plus pemetrexed, the median was 98.0 days, with a 95% confidence interval from 37.0 to 197.0 days.
These are separate descriptive summaries for the four treatment groups. The docetaxel groups and pemetrexed groups each allow a within-backbone descriptive comparison of the apricoxib and placebo medians. The registry record does not post a hazard ratio, a confidence interval for a treatment contrast, a p-value, or another inferential comparison for either pair. The group medians alone do not establish whether an observed difference is distinguishable from random variation.
The confidence intervals communicate uncertainty around each group median. In general, a confidence interval is a range of values compatible with the data under the analysis procedure; it does not mean that the true median is known to lie within the reported interval with certainty. The intervals are broad, and the posted intervals for each pair overlap. That visual feature does not substitute for a formal treatment comparison, and it cannot establish equivalence or absence of a difference.
The endpoint group counts were 17.0, 20.0, 19.0, and 16.0 across the four groups. These relatively limited group counts are part of the context for reading the uncertainty, but the record does not provide a sample-size justification or precision target. It also does not report an analysis population, censoring details, or the statistical method used to estimate the medians and confidence intervals.
Accordingly, the posted data describe the observed progression-free survival summaries by group; they do not provide a complete estimate of the randomized treatment effect. The primary comparison remains the scientific question, but its inferential result is not reported in the registry record. No conclusion about benefit, lack of benefit, or comparative safety should be drawn from the medians alone.
9. Statistical Methods Explained
Progression-free survival is a time-to-event outcome. Each participant's time begins at randomization, and the event is defined in the registry as the first date recurrent or progressive disease is objectively documented. The record refers to RECIST v1.0 and specifies three ways progression could be established: a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
What does a median time summarize?
In general, the median time-to-event is the time at which the estimated proportion remaining free of the event reaches one half. It gives a central summary of the event-time distribution, not the mean and not a description of every participant. It also does not express the size of a treatment contrast by itself. The posted medians are 75.0 days for apricoxib plus docetaxel, 97.0 days for placebo plus docetaxel, 103.0 days for apricoxib plus pemetrexed, and 98.0 days for placebo plus pemetrexed.
Time-to-event data can include participants whose event has not been documented by the end of their available follow-up. General time-to-event analyses account for such incomplete event information through censoring, rather than treating each participant's observed follow-up time as if it were an event time. Whether and how censoring was addressed in this trial's reported medians is not reported in the registry record.
What do the confidence intervals convey?
Each group median is reported with a 95% confidence interval: 47.0 to 104.0 days for apricoxib plus docetaxel; 48.0 to 216.0 days for placebo plus docetaxel; 62.0 to 225.0 days for apricoxib plus pemetrexed; and 37.0 to 197.0 days for placebo plus pemetrexed. In general, confidence intervals show the uncertainty associated with an estimate under the method used. A wider interval indicates less precision than a narrower interval, while neither interval width nor overlap is a formal test of a treatment difference.
The registry record does not name the procedure used to calculate the confidence intervals or say whether medians were estimated from a Kaplan-Meier curve. Those are common general methods for time-to-event summaries, but they cannot be attributed to this trial without a reported method. Nor does the record give the number of events, censoring pattern, or follow-up distribution.
Why is a treatment contrast important?
A randomized trial's treatment question concerns the contrast between assigned groups, not only the separate median in each group. General methods may summarize that contrast with a hazard ratio or another effect estimate and its uncertainty, depending on the analysis plan and assumptions. A hazard ratio compares event rates over time under a specified model; it is not a ratio of the posted medians. No hazard ratio or other treatment-effect estimate is reported in the registry record, and no analyses are posted for the primary endpoint.
The four-arm arrangement also calls for care in defining the comparison. The within-docetaxel comparison is apricoxib plus docetaxel against placebo plus docetaxel; the within-pemetrexed comparison is apricoxib plus pemetrexed against placebo plus pemetrexed. A pooled comparison across chemotherapy backbones would require a defined analysis and justification. Such a pooled result is not reported in the registry record.
How should sample-size illustrations be understood?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, allocation, and error rates. It is not evidence that a study had a particular probability of detecting its observed result. Any planning illustration based on an observed effect should be interpreted as hypothetical, not as observed power or as the trial's original design calculation. The registry record does not report the trial's own sample-size justification, target effect, or power calculation.
There is no basis in the posted results to recalculate a treatment-effect estimate from the group medians. The record describes one primary outcome measure and reports group medians with confidence intervals, but it does not provide sufficient model output or event-level data for a new unadjusted treatment comparison. The sponsor's formal analysis is also not posted in the registry record. Therefore, interpretation should remain with the reported group summaries and their uncertainty, without assigning a statistical significance result.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and no posted analyses. It does not report a multiplicity strategy, such as whether the primary endpoint was tested once or whether comparisons across the chemotherapy options were treated as separate hypotheses. Without a stated testing plan and inferential results, it is not possible to determine how any multiplicity concerns were addressed.
No secondary outcomes are posted. The record therefore does not allow assessment of whether additional outcomes were prespecified, analyzed, or selectively omitted. The registry record does not report interim analyses or stopping rules; these should not be inferred from the phase or completed status of the study.
Missing-data handling is not reported. For a time-to-event outcome, important details include how participants without a documented progression were handled, what rules defined censoring, and whether participants with incomplete assessments remained in the analysis. These details are not available in the registry record. The record also does not describe the analysis population, including whether the reported groups reflect all randomized participants or a different population.
Although the overall enrollment is 109, the listed endpoint group counts are 17.0, 20.0, 19.0, and 16.0. The record does not explain the relationship between those endpoint counts and overall enrollment, or describe exclusions, withdrawals, or unavailable endpoint data. These omissions limit assessment of attrition and the potential for missing outcome information to affect the 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 |
|---|---|---|---|
| Apricoxib Plus Docetaxel or Pemetrexed | 11 | 36 | 30.6% |
| Placebo Plus Docetaxel or Pemetrexed | 11 | 36 | 30.6% |
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 |
|---|---|
| Apricoxib Plus Docetaxel or Pemetrexed | 12 of 36 |
| Placebo Plus Docetaxel or Pemetrexed | 11 of 36 |
Most frequent serious adverse event terms
| Event term | Organ system | Apricoxib Plus Docetaxel or Pemetrexed | Placebo Plus Docetaxel or Pemetrexed |
|---|---|---|---|
| Abdominal pain | General disorders | 0 of 36 | 2 of 36 |
| Neutropenia | Blood and lymphatic system disorders | 0 of 36 | 2 of 36 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 2 of 36 | 0 of 36 |
| Headache | General disorders | 1 of 36 | 1 of 36 |
| Hypoxia | General disorders | 1 of 36 | 1 of 36 |
| Thrombosis | Blood and lymphatic system disorders | 0 of 36 | 2 of 36 |
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 36 | 1 of 36 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 36 | 1 of 36 |
| Aseptic meningitis | Nervous system disorders | 1 of 36 | 0 of 36 |
| Atrial flutter | Cardiac disorders | 1 of 36 | 0 of 36 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Apricoxib Plus Docetaxel or Pemetrexed | Placebo Plus Docetaxel or Pemetrexed |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 9 of 36 | 9 of 36 |
| Lymphopenia | Blood and lymphatic system disorders | 1 of 36 | 3 of 36 |
| Leukopenia | Blood and lymphatic system disorders | 3 of 36 | 0 of 36 |
| Lowered WBC count | Blood and lymphatic system disorders | 2 of 36 | 1 of 36 |
| Hyponatremia | General disorders | 2 of 36 | 0 of 36 |
Serious events with the highest arm-level rate: abdominal pain (5.6%), neutropenia (5.6%), dyspnea (5.6%), thrombosis (5.6%), death (2.8%).
The posted serious adverse event figures combine the chemotherapy options within each study-drug group. In the apricoxib plus docetaxel or pemetrexed group, 36 participants were at risk and 11 were reported as affected by serious adverse events. In the placebo plus docetaxel or pemetrexed group, 36 were at risk and 11 were reported as affected. These are group-level counts, not a formal comparison of the treatment strategies.
For other adverse events, 12 of the 36 at-risk participants were affected in the apricoxib group, and 11 of the 36 were affected in the placebo group. The record also lists serious adverse event terms and their percentages: abdominal pain, neutropenia, dyspnea, and thrombosis at 5.6% each; death and febrile neutropenia at 2.8% each. These term percentages should not be treated as treatment-effect estimates.
The separate death-count field is not reported in the registry record. Definitions, event-attribution rules, observation period, and whether participants could contribute more than one event are not reported. The combined groups also do not permit the posted safety figures to be separated by docetaxel versus pemetrexed. These data describe what was recorded; they do not establish comparative safety.
12. What the Result Does, and Does Not, Mean
The posted results show group-specific medians for progression-free survival, together with 95% confidence intervals. They describe the recorded time-to-progression summaries for participants in each of the four groups. The interval estimates indicate uncertainty, and the group counts accompanying the endpoint results provide context for interpreting the precision of those summaries.
These results do not, by themselves, answer whether adding apricoxib changed progression-free survival relative to placebo. The registry record does not provide a hazard ratio, a treatment contrast with a confidence interval, a p-value, or another formal inferential comparison. Separate medians are not a substitute for an estimate of the randomized treatment effect, and the overlapping confidence intervals do not prove that the strategies are equivalent.
The data also do not establish how results would differ between the two chemotherapy backbones. The posted groups allow descriptive reading within each backbone, but a direct contrast between chemotherapy options or a pooled apricoxib effect is not reported. Any claim about such contrasts would require analyses that the registry record does not contain.
The endpoint is defined through objectively documented recurrence or progression using RECIST v1.0 criteria. The registry record does not provide assessment schedules, censoring procedures, independent-review details, or analysis-population definitions. Those details can affect interpretation of time-to-event summaries, so the reported medians should not be read as complete accounts of how progression was assessed and analyzed.
Likewise, the safety figures are counts and listed event percentages across combined chemotherapy options. They do not provide a controlled estimate of a safety difference, and the separate death count is not reported in the registry record. In sum, the posted data support a description of the measured outcomes by group, but do not support a definitive claim about efficacy or comparative safety.
13. Why This Trial Matters Statistically
This study is statistically informative because it illustrates the distinction between descriptive outcome summaries and an inferential treatment comparison. A median and confidence interval for each randomized group convey the distribution's central point and uncertainty around that group estimate. They do not quantify the treatment contrast that addresses the primary randomized question.
The four treatment groups also make the estimand important. Apricoxib was paired with docetaxel or pemetrexed, and the corresponding placebo groups used those same chemotherapy options. Reading each within-backbone comparison separately preserves the design structure. Combining groups or comparing across chemotherapy options would require an explicitly defined analysis, which is not reported in the registry record.
The record demonstrates why confidence intervals should be interpreted as uncertainty summaries rather than as a shortcut for hypothesis testing. Their widths are substantial, and overlap alone does not establish whether groups differ. A formal contrast and its uncertainty would be needed for that assessment. The record does not post such an estimate, so the numerical summaries cannot be converted into a claim of statistical significance.
It also highlights the importance of reporting analysis details for time-to-event outcomes. Endpoint definitions are available, including the RECIST v1.0 progression criteria, but censoring, event counts, analysis populations, and missing-data procedures are not reported. Without those details, readers have limited ability to evaluate how the endpoint summaries were constructed or how robust they are to incomplete follow-up.
Finally, the study's overall enrollment and the smaller counts accompanying the endpoint results are not reconciled in the record. Transparent participant flow and a stated analysis plan would help readers connect the randomized design to the reported estimates. The posted material therefore offers useful descriptive information while leaving central inferential and implementation questions unanswered.
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.
A central limitation of the registry record is that it does not report a treatment-effect estimate for the primary endpoint. The outcome is presented as a median and 95% confidence interval for each group, but no hazard ratio, contrast interval, p-value, or other inferential result is posted. The record also contains no posted analyses, so there is no formal comparison to interpret.
The endpoint counts accompanying the results are 17.0, 20.0, 19.0, and 16.0, while overall enrollment is 109. The registry record does not reconcile these figures or explain participant flow. Reasons for unavailable endpoint information, exclusions from analysis, and withdrawals are not reported.
Important time-to-event analysis details are absent, including the number of progression events, follow-up distribution, censoring rules, method for estimating medians and confidence intervals, and analysis population. The registry defines progression using RECIST v1.0 but does not report assessment frequency, independent review, or how progression assessments were handled when incomplete.
The four-group structure is not accompanied by a reported plan for handling multiple comparisons or for combining results across chemotherapy options. There are no posted secondary outcomes, and the record does not report interim analyses, the sample-size justification, or a detailed statistical analysis plan. The listed safety results combine docetaxel and pemetrexed groups and therefore do not provide backbone-specific safety summaries. The separate death count is not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer — NCT00771953.
- Registry record last updated 2019-10-30; status last verified 2019-10.
- Results first posted 2013-07-22.
- 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 randomized, double-blind, placebo-controlled, multicenter phase 2 trial of apricoxib with docetaxel or pemetrexed in Stage IIIb or Stage IV non-small cell lung cancer. Enrollment was 109. The primary endpoint was progression-free survival, measured in days from randomization to the first objective documentation of recurrent or progressive disease using RECIST v1.0.
Four groups are listed, with median progression-free survival of 75.0 days, 97.0 days, 103.0 days, and 98.0 days, each with a 95% confidence interval. The registry record does not post a formal treatment-effect estimate, inferential analysis, or details of the analysis population and missing-data procedures. Safety figures are reported for groups that combine the chemotherapy options.