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 A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (NCT02753127), a randomized phase 3 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02753127 |
| Phase | Phase 3 |
| Condition | Colorectal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1253 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sumitomo Pharma America, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Adults with previously treated metastatic colorectal cancer. The primary-outcome description also refers to pSTAT3 subpopulations defined using a Clinical Trial Assay and a specimen within a defined cut-section stability window; further details of that definition are not reported in the registry record.
Intervention
Napabucasin (BBI-608) in combination with FOLFIRI. FOLFIRI includes 5-fluorouracil, leucovorin and irinotecan. Bevacizumab could be added to the regimen.
Comparator
FOLFIRI, with bevacizumab also permitted. The registry describes FOLFIRI administration every 2 weeks; additional details of treatment delivery are not fully reported in the registry record.
Primary question
How did overall survival, measured from randomization until death from any cause, compare between the randomized treatment groups? A single comparative result is not reported in the registry record, so the direction and precision of the between-group estimate cannot be described from these results.
The trial was international, multicenter, prospective, randomized, open-label, and used a parallel-group design. It enrolled 1253 participants. Its central statistical question is about time to death, rather than simply whether a participant was alive at a particular visit. That distinction matters because survival analysis uses information about the timing of events and can account for participants whose death was not observed before the analysis cutoff.
The registry also lists progression-free survival, disease control rate, objective response rate, changes in global health status and physical functioning, and adverse events among secondary outcomes. The primary endpoint remains overall survival. The registry record does not report a single summarized comparison for that endpoint in the registry record for this analysis.
3. Trial Design
This was a phase 3 randomized trial with a parallel-group structure and no masking. The registry describes it as an international, multicenter, prospective study with an adaptive design. The specific adaptive procedures, including whether they changed allocation or other design features, are not reported in the registry record.
The comparison was napabucasin plus FOLFIRI versus FOLFIRI. Bevacizumab was permissible in either regimen, so the treatment contrast concerns the addition of napabucasin to a FOLFIRI-based regimen, while allowing bevacizumab in both groups. The registry describes chemotherapy administration every 2 weeks. In the napabucasin group, FOLFIRI infusion was to start at least 2 hours after the first daily dose of napabucasin. Further details of treatment implementation are not fully reported in the registry record.
Enrollment was 1253. The trial started in 2016-06, reached primary completion on 2020-04-28, and is recorded as completed. The primary endpoint’s timeframe is described as randomization until death from any cause or the database cutoff date, 28 Apr 2020, with approximately 43 months indicated in the registry.
Randomization is intended to create groups that can be compared without assigning treatment according to participants’ measured characteristics. Open-label treatment means masking was absent; how that could affect subjective outcomes is a general design consideration, rather than evidence that it affected this trial. Overall survival is less dependent on subjective assessment than outcomes such as symptom ratings, but the registry record does not report details of outcome adjudication or the statistical plan.
The registry lists pSTAT3-defined subpopulations in its primary-outcome description. How these subpopulations relate to the primary comparison, and the full eligibility and analysis-population rules, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Completers included patients who died, withdrew consent to survival follow up or were lost to follow up.
Overall Study
| Stage | Napabucasin + FOLFIRI ± Bevacizumab | FOLFIRI ± Bevacizumab |
|---|---|---|
| STARTED | 624 | 629 |
| Discontinued Due to Death | 507 | 499 |
| Completion of Survival Follow-Up Due to Study Completion | 64 | 62 |
| COMPLETED | 571 | 561 |
| NOT COMPLETED | 53 | 68 |
Reasons for not completing this period:
| Reason | Napabucasin + FOLFIRI ± Bevacizumab | FOLFIRI ± Bevacizumab |
|---|---|---|
| Lost to Follow-up | 13 | 11 |
| Withdrawal by Subject | 37 | 47 |
| Other | 3 | 8 |
| Hospice | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: The pSTAT3 subpopulations will be defined by the results of a Clinical Trial Assay (CTA) for a specimen with an age within a defined cut-section stability (CSS) window. A patient with positive pSTAT3 status within a defined CSS window is the one with pSTAT3 positive designated by CTA with specimen age up to 6 months at interim analysis or up to the final CSS window at final analysis.
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 | Napabucasin + FOLFIRI ± Bevacizumab | FOLFIRI ± Bevacizumab | Total |
|---|---|---|---|---|
| Participants analysed | 624 | 629 | 1253 | |
| Age, Continuous | years | 60.1 (SD 11.17) | 59.6 (SD 11.14) | 59.8 (SD 11.16) |
| Sex: Female, Male: Female | Participants | 240 | 254 | 494 |
| Sex: Female, Male: Male | Participants | 384 | 375 | 759 |
| Race/Ethnicity, Customized: White | participants | 375 | 370 | 745 |
| Race/Ethnicity, Customized: Black or African American | participants | 29 | 38 | 67 |
| Race/Ethnicity, Customized: Asian | participants | 197 | 194 | 391 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Other | participants | 9 | 12 | 21 |
| Race/Ethnicity, Customized: Missing | participants | 13 | 14 | 27 |
| Region of Enrollment: Singapore | participants | 8 | 9 | 17 |
| Region of Enrollment: Hong Kong | participants | 1 | 11 | 12 |
| Region of Enrollment: United States | participants | 203 | 209 | 412 |
| Region of Enrollment: Czechia | participants | 18 | 19 | 37 |
| Region of Enrollment: Japan | participants | 63 | 63 | 126 |
| Region of Enrollment: Spain | participants | 74 | 62 | 136 |
| Region of Enrollment: Canada | participants | 21 | 15 | 36 |
| Region of Enrollment: Netherlands | participants | 16 | 21 | 37 |
| Region of Enrollment: South Korea | participants | 44 | 39 | 83 |
| Region of Enrollment: Belgium | participants | 16 | 24 | 40 |
| ECOG Performance Status: ECOG: 0 | Participants | 333 | 332 | 665 |
| ECOG Performance Status: ECOG: 1 | Participants | 291 | 297 | 588 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 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 a time-to-event endpoint: the outcome includes both whether death was observed and the time at which it occurred. The registry states that participants alive at an interim or final analysis, and participants lost to follow-up, were censored on the date they were last known to be alive.
In general, overall survival is used in clinical trials because death is a clearly defined event and the time-to-event framework can use follow-up information even when not every participant has an observed event by the analysis cutoff. Censoring does not mean that a participant had no event ever; it means that the event was not observed during the available follow-up, and the analysis uses the last known time alive as the endpoint of observed follow-up.
The registry identifies the primary endpoint as median overall survival with a 95% confidence interval. A median summarizes the time point by which half of the relevant survival distribution has experienced the event, subject to the analysis and population definition. A confidence interval conveys uncertainty around an estimated quantity; in general, a wider interval indicates less precision than a narrower one. The numerical median estimates and confidence intervals are not reported in the registry record in the registry record for this analysis.
The registry names randomization as the starting point and death from any cause as the event. Its stated database cutoff was 28 Apr 2020. A single comparison of the primary endpoint is not reported in the registry record, so the posted information cannot establish the estimated size or precision of a difference between the groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial addresses whether overall survival differed between randomized groups receiving napabucasin plus FOLFIRI or FOLFIRI, with bevacizumab permitted in either group. The registry defines overall survival as time from randomization until death from any cause and identifies the median and its 95% confidence interval as the primary outcome measure. However, the primary outcome has several categories or time points and is not reduced to one comparison in the registry record. The median estimates, confidence intervals, and a single comparative result are not reported in the registry record in the registry record for this analysis.
As a result, the treatment contrast cannot be characterized numerically from these registry entries. There is no reported hazard ratio or confidence interval to describe the relative event rate over follow-up, and there are no primary-endpoint medians to describe survival times in the groups. It would not be appropriate to infer a benefit, lack of benefit, or equivalence from the absence of a summarized comparison.
For context, the registry records 507 deaths in the napabucasin plus FOLFIRI group and 499 deaths in the FOLFIRI group. These counts alone do not provide a complete time-to-event comparison. Interpretation also depends on follow-up time, censoring, the analysis population, and the statistical method. Those counts should therefore not be treated as a substitute for the sponsor’s time-to-event analysis.
The registry lists progression-free survival, disease control rate, objective response rate, changes in global health status and physical functioning, and adverse events as secondary outcomes. Their comparative estimates and uncertainty are not included in the registry record, so they cannot resolve the missing primary-endpoint comparison. The registry also refers to pSTAT3-defined subpopulations, but the full subgroup definitions and corresponding results are not reported in the registry record.
Overall, the record establishes the trial’s question, design, endpoint definition, and some event and safety counts. It does not provide enough primary-outcome results to quantify the estimated treatment contrast or its precision. Any interpretation of the trial’s effect on overall survival must rely on the sponsor’s reported time-to-event analysis when available; that analysis takes precedence over a simple re-calculation from summary statistics. No such numerical hazard ratio is reported in the registry record.
9. Statistical Methods Explained
Overall survival is a time-to-event outcome. General explanation: such an analysis considers the observed time until an event, rather than treating every participant as if follow-up ended at the same point. Participants who are alive at the analysis cutoff or lost to follow-up contribute information until their last known date alive, as the registry’s endpoint description specifies.
What does censoring mean?
In general, censoring marks the end of observed follow-up when the event of interest has not been observed. It is not the same as recording that the event never happened. For this trial, the registry says that participants alive at an interim or final analysis, or lost to follow-up, were censored on the date they were last known to be alive. The assumptions used to handle censoring and the detailed analysis procedures are not reported in the registry record.
What does a median and confidence interval communicate?
The registry specifies median overall survival and a 95% confidence interval. In general, the median is a time-based summary of the survival distribution. A confidence interval expresses uncertainty in an estimate: it describes a range of values compatible with the data under the method’s assumptions. It does not give the probability that a particular treatment effect is true. The numeric medians and intervals are not reported in the registry record in the registry record for this analysis.
How is a treatment comparison commonly expressed?
General explanation: a hazard ratio compares event rates over time between groups, under a time-to-event model. It is a relative measure and does not directly state how many months separate group medians. Its interpretation depends on the analysis and assumptions, including how the relative event rate behaves over time. The registry’s statistical-method description indicates that sponsor-reported hazard ratios are the basis for time-to-event comparisons. A numeric sponsor-reported hazard ratio is not reported in the registry record here, so no estimate or precision can be interpreted.
The sponsor’s analysis is the relevant source for a formal treatment comparison. A simple recalculation from posted summary statistics, if available, would be unadjusted and would not replace that analysis. The registry entries available for this interpretation do not include a recalculated estimate or the sponsor’s numerical estimate.
Why does follow-up matter?
General explanation: time-to-event estimates use both events and the duration of observed follow-up. The number of deaths alone does not capture when deaths occurred or how long participants without an observed death were followed. A database cutoff also limits the period in which events can be recorded. The registry states that the cutoff was 28 Apr 2020 and describes the timeframe as approximately 43 months. The precise follow-up distribution is not reported in the registry record.
The registry’s planning illustration describes a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. For time-to-event planning, it describes total event counts using the Schoenfeld method. These are planning assumptions, not evidence of observed power, and the numerical planning outputs are not reported in the registry record. They should not be confused with the trial’s actual design justification, which is not reported in the registry record.
General explanation: time-to-event sample-size planning is often framed around the number of events because event occurrence contributes information about the comparison. A participant count alone does not determine how much information the analysis will have; the timing and number of events and the allocation pattern also matter. The registry’s stated planning approach does not reveal the actual enrollment rationale or the trial’s adaptive procedures.
Other listed outcomes use different statistical concepts. Progression-free survival is also a time-to-event measure, whereas response and disease control rates are proportions, and changes in health status or functioning are continuous outcomes. In general, these outcome types require methods suited to their scales and data structure. Specific methods for the secondary outcomes are not reported in the registry record.
Over-dispersion is a general issue for count or proportion data when variability exceeds what a simple model assumes; accounting for it can affect standard errors and uncertainty estimates. The registry entries do not say that over-dispersion occurred or that a particular correction was used in this trial. The analysis methods for the listed secondary outcomes are not reported in the registry record. Accordingly, no model-specific interpretation of those outcomes can be made from the registry entries.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes in addition to overall survival: progression-free survival, disease control rate, objective response rate, changes from baseline in global health status and physical functioning at specified assessment times, and adverse events. The record lists 7 outcome measures and 8 analyses. Multiple outcomes and analyses can raise multiplicity concerns because examining many hypotheses can increase the chance of at least one apparently notable result. General statistical practice may address this through prespecified testing sequences or adjustment procedures, but the approach used in this trial is not reported in the registry record.
The registry describes an adaptive design, but the rules governing adaptation, any interim decision criteria, and whether those procedures affected statistical testing are not reported in the registry record. Although the primary endpoint description refers to interim or final analyses when defining censoring, the timing and purpose of analyses are not reported in the registry record.
For overall survival, the registry states that participants alive at an analysis or lost to follow-up were censored at the last date known alive. This describes how the endpoint is defined for those participants, but does not give the amount or pattern of missing follow-up, or the assumptions and sensitivity analyses used to address it. Those details are not reported in the registry record.
The primary-outcome description refers to pSTAT3 subpopulations based on a Clinical Trial Assay and a defined specimen stability window. The complete analysis-population rules, including how those subpopulations were used in the primary analysis, are not reported in the registry record. The handling of missing assay results and other analysis populations is also not reported in the registry record.
Without the prespecified testing strategy, analysis-population definitions, and missing-data procedures, the precision and interpretation of any outcome comparisons cannot be fully evaluated from the registry information.
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 |
|---|---|---|---|
| Napabucasin + FOLFIRI ± Bevacizumab | 234 | 622 | 37.6% |
| FOLFIRI ± Bevacizumab | 201 | 610 | 33.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Napabucasin + FOLFIRI ± Bevacizumab | 507 of 624 |
| FOLFIRI ± Bevacizumab | 499 of 629 |
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 |
|---|---|
| Napabucasin + FOLFIRI ± Bevacizumab | 619 of 622 |
| FOLFIRI ± Bevacizumab | 602 of 610 |
Most frequent serious adverse event terms
| Event term | Organ system | Napabucasin + FOLFIRI ± Bevacizumab | FOLFIRI ± Bevacizumab |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 39 of 622 | 19 of 610 |
| Pyrexia | General disorders | 18 of 622 | 16 of 610 |
| Abdominal Pain | Gastrointestinal disorders | 17 of 622 | 16 of 610 |
| Disease Progression | General disorders | 17 of 622 | 15 of 610 |
| Intestinal Obstruction | Gastrointestinal disorders | 10 of 622 | 15 of 610 |
| Dehydration | Metabolism and nutrition disorders | 15 of 622 | 9 of 610 |
| Small Intestinal Obstruction | Gastrointestinal disorders | 10 of 622 | 12 of 610 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 12 of 622 | 9 of 610 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 8 of 622 | 12 of 610 |
| Vomiting | Gastrointestinal disorders | 10 of 622 | 8 of 610 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Napabucasin + FOLFIRI ± Bevacizumab | FOLFIRI ± Bevacizumab |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 526 of 622 | 329 of 610 |
| Nausea | Gastrointestinal disorders | 376 of 622 | 308 of 610 |
| Fatigue | General disorders | 235 of 622 | 219 of 610 |
| Vomiting | Gastrointestinal disorders | 256 of 622 | 180 of 610 |
| Decreased Appetite | Metabolism and nutrition disorders | 233 of 622 | 189 of 610 |
| Abdominal Pain | Gastrointestinal disorders | 255 of 622 | 154 of 610 |
| Neutrophil Count Decreased | Investigations | 149 of 622 | 179 of 610 |
| Neutropenia | Blood and lymphatic system disorders | 154 of 622 | 165 of 610 |
| Anaemia | Blood and lymphatic system disorders | 154 of 622 | 148 of 610 |
| Constipation | Gastrointestinal disorders | 126 of 622 | 173 of 610 |
Serious events with the highest arm-level rate: diarrhoea (6.3%), pyrexia (2.9%), abdominal pain (2.7%), disease progression (2.7%), intestinal obstruction (2.5%).
The registry reports serious adverse events separately for the two treatment groups. For napabucasin plus FOLFIRI, 622 participants were at risk and 234 were affected; for FOLFIRI, 610 were at risk and 201 were affected. These are reported counts, not a comparative statistical analysis. No confidence intervals or adjusted comparison for serious adverse events are reported in the registry record.
The registry also lists other adverse events: 619 affected among 622 at risk in the napabucasin plus FOLFIRI group, and 602 affected among 610 at risk in the FOLFIRI group. The meaning and collection details for this category, beyond the registry labels, are not reported in the registry record. The death counts recorded are 507 and 499, respectively; the record does not provide a safety-specific causal interpretation for these deaths.
The most frequent listed serious adverse-event terms are diarrhoea (6.3%), pyrexia (2.9%), abdominal pain (2.7%), disease progression (2.7%), intestinal obstruction (2.5%), and dehydration (2.4%). The denominator and group attribution for these percentages are not reported in the registry record, so they should not be interpreted as group-specific rates or compared between groups.
Adverse-event counts do not by themselves establish that treatment caused an event. The registry entries do not report severity grading details, exposure-adjusted rates, or a formal comparative safety analysis. These figures describe recorded events and should be interpreted with those limits in mind.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of napabucasin added to FOLFIRI against FOLFIRI, with bevacizumab permitted in either group. It identifies overall survival as the primary endpoint and defines it from randomization until death from any cause. The record also gives enrollment, trial status, the database cutoff, and selected safety counts.
What cannot be established from these registry entries is the size, direction, or precision of the primary treatment comparison. The median overall survival estimates, 95% confidence intervals, and a single comparative result are not reported in the registry record. The number of deaths in each group does not replace a time-to-event analysis, because those counts do not describe the timing of events or censoring. Therefore, the available record does not support a conclusion that one regimen improved survival, had no effect, or was equivalent to the other.
The listed secondary outcomes and adverse-event counts add context about what the trial measured, but their comparative results and analysis details are not reported in the registry record. The serious adverse-event terms are accompanied by percentages, but the denominator and group attribution are not reported. They cannot be used to make a direct comparative safety estimate.
General statistical interpretation distinguishes absence of a reported result from evidence of no difference. A non-significant result, if reported, would not automatically establish equivalence; an equivalence conclusion requires a defined margin and appropriate analysis. No such conclusion or margin is reported in the registry record.
The most defensible reading is therefore limited: the trial was designed to compare overall survival in these treatment groups, and the registry supplies the endpoint definition and some descriptive counts, but the numerical primary comparison is not reported in the registry record. Any stronger interpretation would require the sponsor’s reported analysis and its uncertainty estimates.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized phase 3 study with a time-to-event primary endpoint and an open-label, parallel-group design. Randomization supports a structured comparison between the treatment groups, while overall survival focuses on the timing of death rather than a single status assessment. The registry also describes an adaptive design, although its specific procedures are not reported in the registry record.
The trial’s treatment contrast is not simply two fixed drug combinations in which every component differs: bevacizumab was permissible in both groups. This matters when interpreting the question as the addition of napabucasin to a FOLFIRI-based regimen. The record does not report how bevacizumab use was distributed or whether analyses accounted for its use.
Statistically, the endpoint definition makes censoring and follow-up important. Death counts alone cannot convey the full survival comparison, and the median and confidence interval are needed to understand the group estimates and their precision. Those numerical results are not reported in the registry record in the registry record for this analysis.
The registry also names several secondary outcomes and pSTAT3-defined subpopulations. Multiple outcomes and subgroup analyses can make prespecification and multiplicity control important, but the relevant statistical plan is not reported in the registry record. The record therefore illustrates why a trial’s design and endpoint definitions are useful, while also showing why complete analysis details and effect estimates are necessary for a statistical conclusion.
Its completed status and enrollment of 1253 describe the trial’s scale and administrative status, but neither alone establishes the strength or direction of the primary result. Interpretation depends on the reported analysis, its assumptions, and the uncertainty around the estimated comparison.
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 main limitation for interpreting the primary endpoint is that its numerical results are not reported in the registry record in the registry record for this analysis. No median estimates, confidence intervals, or sponsor-reported hazard ratio are available to characterize the treatment contrast. The record indicates that the primary outcome was not reduced to one comparison because it has several categories or time points.
The primary-outcome population description refers to pSTAT3-defined subpopulations and a specimen stability window, but the full definitions, assay-result handling, and relationship of those populations to the main analysis are not reported in the registry record. This limits assessment of which participants contributed to each reported analysis.
The study is described as adaptive, but the adaptation rules and their consequences for enrollment, interim monitoring, or statistical testing are not reported in the registry record. The multiplicity strategy, detailed analysis methods, and secondary-outcome results are also not reported.
For safety, the registry provides counts and a list of serious adverse-event terms, but the percentage denominator and group attribution for the listed terms are not reported. The registry entries do not describe event exposure time, severity grading procedures, or a formal comparative safety analysis. The counts should therefore be read descriptively rather than as adjusted comparisons.
The registry states the database cutoff and an approximate timeframe, but the detailed follow-up distribution and missing-data sensitivity analyses are not reported. These limitations do not establish that the study’s analyses were inadequate; they indicate that the information needed to evaluate them is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer — NCT02753127.
- Registry record last updated 2023-11-15; status last verified 2023-11.
- Results first posted 2022-04-26.
- 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, open-label, parallel-group phase 3 trial of napabucasin plus FOLFIRI versus FOLFIRI in adults with previously treated metastatic colorectal cancer. Bevacizumab was permitted in either regimen. Enrollment was 1253, and the trial is described as international, multicenter, prospective, and adaptive.
The primary endpoint was overall survival, defined as time from randomization until death from any cause, with censoring for participants alive or lost to follow-up at their last known date alive. The database cutoff was 28 Apr 2020; the timeframe is described as approximately 43 months. The registry also lists progression-free survival, response and disease-control outcomes, health-status and functioning changes, and adverse events.
Death and adverse-event counts are reported, but the primary median estimates, confidence intervals, and a single comparative survival result are not reported in the registry record in the registry record for this analysis. The statistical plan, adaptive procedures, multiplicity approach, and detailed analysis-population rules are also not reported.