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 Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors (NCT02494596), a non-randomized phase 1 study. The primary outcome is Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02494596 |
| Phase | Phase 1 |
| Condition | Solid Tumor |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced solid tumors whose disease had progressed during or after standard therapy, or for whom standard therapy was unavailable. The registry reports total enrollment of 19.
Intervention
Combination treatment with rhuMAb 2C4 and capecitabine, tested in escalating capecitabine dose cohorts. The registry describes capecitabine dose levels of 825 mg/m^2, 1000 mg/m^2, and 1250 mg/m^2.
Comparator
There was no randomized control group. Participants were assigned to non-randomized dose cohorts, so the cohorts are not a like-for-like control comparison.
Primary question
What was the maximum tolerated dose combination of capecitabine and pertuzumab during Cycle 1 (3 Weeks), using the registry’s dose-limiting toxicity definition?
This is a dose-finding question, rather than a question about whether the combination is more effective than another treatment. The study description says participants in escalating-dose cohorts were evaluated for dose-limiting toxicities to determine the maximum tolerated dose. The registry defines that dose as the highest tolerated combination without causing dose-limiting toxicities. Its definition includes specified severe toxicities and toxicity judged intolerable by the investigator and related to either compound.
The registry names rhuMAb 2C4 in the study title and intervention information, while the primary endpoint and adverse-event group labels use pertuzumab. The record does not give a numerical primary endpoint result. It therefore does not establish which dose combination met the endpoint definition or how the dose-finding decision was reached. The posted population and cohort information describe the study’s setting, but they do not answer a comparative efficacy question.
3. Trial Design
This was a Phase Ib, open-label, multicenter study, recorded as Phase 1. It was completed, with a start date of 2004-01 and primary completion in 2005-09. Total enrollment was 19. The study focused on safety, tolerability, and pharmacokinetics for a combination of rhuMAb 2C4 and capecitabine in participants with advanced solid tumors.
Allocation was non-randomized, masking was absent, and the model was parallel. The registry describes three capecitabine dose levels: 825 mg/m^2, 1000 mg/m^2, and 1250 mg/m^2. The adverse-event groups are labelled Capecitabine 825 + Pertuzumab 1050, Capecitabine 1000 + Pertuzumab 1050, and Capecitabine 1250 + Pertuzumab 1050. The study description says escalating-dose cohorts were assessed for dose-limiting toxicities. More detail about how participants were assigned among cohorts is not reported in the registry record.
Because the study was open-label, treatment assignment was not masked from participants or study personnel. The registry does not report a randomized comparison. Dose cohorts were part of the dose-finding design, not concurrent control arms designed to support a direct treatment-effect comparison. Differences between cohort outcomes could reflect dose, participant characteristics, or other factors; the record does not supply information that would separate those possibilities.
The description indicates that capecitabine was given on Days 1 to 14 of each 3-week cycle, with a single dose on Day -7 for pretreatment assessment. The pertuzumab schedule is described as occurring on Day 1 of each cycle, but the arm descriptions are truncated and do not fully report the fixed-dose details. The complete protocol and a more detailed account of cohort assignment 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: Participants were grouped into three cohorts and received either 825 mg, 1000 mg or 1250 mg capecitabine to determine the maximum tolerated dose.
Overall Study
| Stage | Capecitabine 825 Plus (+) Pertuzumab 1050 | Capecitabine 1000 + Pertuzumab 1050 | Capecitabine 1250 + Pertuzumab 1050 |
|---|---|---|---|
| STARTED | 5 | 7 | 7 |
| COMPLETED | 2 | 2 | 6 |
| NOT COMPLETED | 3 | 5 | 1 |
Reasons for not completing this period:
| Reason | Capecitabine 825 Plus (+) Pertuzumab 1050 | Capecitabine 1000 + Pertuzumab 1050 | Capecitabine 1250 + Pertuzumab 1050 |
|---|---|---|---|
| Insufficient Therapeutic Response | 3 | 3 | 1 |
| Adverse Event | 0 | 1 | 0 |
| Refused Treatment | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Safety Population included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.
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: The Intent-To-Treat (ITT) Population included all participants who received any amount of the study medication. The baseline analysis population represents participants from all three cohorts.
| Characteristic | Unit | Capecitabine + Pertuzumab |
|---|---|---|
| Participants analysed | 18 | |
| Age, Continuous | years | 60.9 (SD 9.10) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine, measured over Cycle 1 (3 Weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m^2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the maximum tolerated dose of the combination of pertuzumab and capecitabine, measured during Cycle 1 (3 Weeks). It was recorded as a number in mg/m^2. The definition identifies the maximum tolerated dose as the highest tolerated combination among capecitabine doses of 825 mg, 1000 mg, or 1250 mg, without causing dose-limiting toxicities.
The registry’s dose-limiting toxicity definition includes non-hematological toxicity of Grade 3 or higher under CTCAE version 3.0, with stated exceptions; Grade 4 neutropenia lasting > 7 days; febrile neutropenia; Grade 4 thrombocytopenia or thrombocytopenia requiring platelet transfusion; and toxicity the investigator considered intolerable and related to either compound. Participants who left before completing the first treatment cycle for reasons other than dose-limiting toxicity were not considered evaluable for this endpoint.
In general, a maximum tolerated dose endpoint is used in early dose-finding research to identify a dose combination that meets a prespecified toxicity-based rule. It is not, by itself, a measure of comparative efficacy or long-term safety. Interpretation depends on how toxicity is defined, the evaluation period, and which participants are considered evaluable. Although the registry describes these elements, the numerical maximum tolerated dose result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The information recorded supports a descriptive reading of an early-phase, non-randomized dose-finding study. Its stated objective was to evaluate safety, tolerability, and pharmacokinetics for rhuMAb 2C4 with capecitabine, using escalating capecitabine dose cohorts and dose-limiting toxicities during the first cycle to inform a maximum tolerated dose. The record does not report the numerical maximum tolerated dose, so the endpoint cannot be interpreted as a reported dose selection.
Enrollment was 19, and the serious and other adverse-event summaries are presented for three dose-labelled groups. These summaries provide counts of participants at risk and affected, not a randomized comparison of the dose levels. For serious adverse events, the record lists 0 affected among 5 at risk in the Capecitabine 825 + Pertuzumab 1050 group, 1 among 6 in the Capecitabine 1000 + Pertuzumab 1050 group, and 1 among 7 in the Capecitabine 1250 + Pertuzumab 1050 group. The other-adverse-event counts are 5 among 5, 6 among 6, and 7 among 7, respectively. These are descriptive cohort summaries; they do not establish that a dose caused a difference in risk.
The record also lists Intestinal Obstruction at 16.7% and Pulmonary Embolism at 14.3% among the top serious terms. It does not give a dose-group attribution for these percentages in the information recorded. Death counts are not reported in the registry record. Event categories, attribution, severity, duration, and participant-level overlap should not be inferred beyond the labels and counts the record gives.
No statistical analysis records are listed, despite the registry describing 12 outcome measures. Thus there are no reported analysis estimates or inferential tests from which to assess uncertainty around a treatment effect or dose comparison. The primary endpoint result is also not reported. These omissions mean the registry record does not provide a quantitative estimate of the selected maximum tolerated dose or a basis for judging precision of that selection.
In general, small dose cohorts can describe observed events but often leave considerable uncertainty about how frequently uncommon harms occur. A zero count in a cohort does not demonstrate that an event cannot occur, and an event in one cohort does not establish a dose relationship. Because allocation was not randomized and the groups were not a like-for-like control comparison, between-cohort contrasts should not be read as causal effects. Any sample-size values shown as planning illustrations are not observed power, and the record’s non-randomized design does not support treating them as a substitute for a control comparison.
9. Statistical Methods Explained
The study’s central statistical task was dose finding. Rather than assigning participants randomly to treatment and control groups to estimate a comparative effect, the registry describes enrollment in escalating-dose cohorts and evaluation for dose-limiting toxicities. The primary endpoint was a maximum tolerated dose combination, defined through observed toxicities during Cycle 1 (3 Weeks). This makes the endpoint a decision based on a toxicity rule, not a conventional estimate of a mean difference between two randomized groups.
What does a dose-limiting toxicity rule do?
In general, a dose-limiting toxicity rule translates clinical observations into a decision criterion. The registry identifies the kinds of toxicity that qualify, the evaluation period, and a rule for participants who withdraw before completing that cycle for reasons other than dose-limiting toxicity. Those specifications matter because changing the event definition or the evaluable population can change which dose appears to meet a threshold. The registry record does not report the dose-level decision process, the number evaluable for the primary endpoint, or the numerical endpoint result.
The rule includes several toxicity types: non-hematological toxicity of Grade 3 or higher, with listed exceptions; Grade 4 neutropenia lasting > 7 days; febrile neutropenia; Grade 4 thrombocytopenia or thrombocytopenia requiring platelet transfusion; and toxicity regarded by the investigator as subjectively intolerable and related to either compound. In general, a composite toxicity definition can capture clinically distinct events, but the combined endpoint does not show the individual contribution of each event unless component results are also reported. The record lists percentage of participants with dose-limiting toxicities as a secondary outcome, but does not report an analysis result for it.
How should the cohort structure be understood?
The design is recorded as non-randomized, open-label, and parallel. The capecitabine dose levels were 825 mg/m^2, 1000 mg/m^2, and 1250 mg/m^2, and the adverse-event summaries identify pertuzumab 1050 in each group label. In general, a dose-escalation design uses experience at one or more dose levels to inform subsequent evaluation, but the specific escalation algorithm and its decision thresholds are not reported in the registry record. Those details should not be reconstructed from the cohort labels alone.
Non-randomized allocation differs from random assignment because cohort membership may be related to study sequence or other design decisions. The record does not specify participant characteristics by dose cohort, so it is not possible to assess whether groups were similar at baseline. Even when group counts are available, a contrast between cohorts can reflect more than dose. The posted results therefore support description of each cohort, not a like-for-like comparative treatment effect.
What do the adverse-event counts estimate?
The serious adverse-event summaries give, for each dose-labelled group, the number at risk and the number affected. The other-adverse-event summaries use the same format. These counts describe participants with at least one event in the relevant category, as represented by the registry summary; they are not event rates per unit of time. The record does not provide exposure-adjusted rates or participant-level event histories. In general, counts depend on the number observed and the duration and completeness of observation, so they should not be interpreted as directly comparable risk estimates when follow-up or exposure differs or is unknown.
Serious adverse events and other adverse events are distinct reporting categories. A participant may experience more than one event, and the available summaries do not establish that categories are mutually exclusive. The listed serious terms, Intestinal Obstruction at 16.7% and Pulmonary Embolism at 14.3%, are reported as top serious terms, but the record does not specify their dose-group attribution in this information. No additional calculation from those percentages is needed to describe them, and no inference about relative frequency between groups is warranted from the term list alone.
What would an uncertainty interval mean?
In general, a confidence interval describes a range of values compatible with an estimate under a specified statistical model and sampling assumptions. A narrower interval indicates greater precision under those assumptions; it does not correct for bias from non-random allocation or incomplete reporting. The registry record does not report confidence intervals for the primary endpoint or adverse-event summaries, and it does not list analysis records. Consequently, no interval-based precision statement can be made from the registry results.
The sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the stated fraction of the observed effect defines the effect to detect. Such calculations are planning exercises rather than evidence about the actual operating characteristics of this trial. They are not observed power. Moreover, the stated design assumptions involve a two-arm allocation, whereas this trial is recorded as non-randomized and its arms are not a like-for-like control comparison. The trial’s own sample-size justification is not reported in the registry record.
For time-to-event planning, the assumptions describe total event counts using the Schoenfeld approach; other planning quantities are described as participants per arm. These are general distinctions in sample-size calculation, not observed study outcomes. The record does not report an inferential comparison or a primary efficacy estimate to which those planning values could be applied. No new effect estimate or sample-size calculation can be inferred from the listed cohort counts alone.
How should pharmacokinetic outcomes be read?
The registry lists pharmacokinetic outcomes for pertuzumab, including plasma half-life, maximum plasma concentration, time to maximum concentration, area under the concentration curve from time zero to the last measurement, area under the curve from time zero to infinity, apparent volume of distribution, and apparent total clearance. In general, these measures describe different features of drug concentration over time: peak level, timing of peak, exposure over a measured interval or extrapolated interval, and disposition. The registry lists these outcomes but does not report their numerical results or analysis methods. It is therefore not possible to characterize the concentration profile or its precision from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the maximum tolerated dose, the percentage of participants with dose-limiting toxicities, multiple pharmacokinetic measures, and safety outcomes. It lists 0 analysis records. No statistical analysis plan, hierarchy among secondary outcomes, or adjustment for multiple testing is reported in the registry record. In general, testing many outcomes can increase the chance of at least one apparently notable result when each is assessed separately. An adjustment or prespecified hierarchy can help address that issue, but the record does not document whether either was used.
Missing-data procedures are not reported in the registry record. The primary endpoint definition does state that participants who withdrew before completing the first treatment cycle for reasons other than dose-limiting toxicity were not considered evaluable for dose-limiting toxicity. The record does not give the number of such participants, the number evaluable, or how any other incomplete safety or pharmacokinetic observations were handled. It also does not describe imputation or sensitivity analyses.
The primary endpoint population is described as the Safety Population: participants who received any amount of study medication and had at least one post-baseline safety follow-up. That definition identifies a population for safety assessment, but the record does not report how many participants met it or whether the primary endpoint analysis used precisely that population. The complete analysis populations and participant flow by cohort are not reported in the registry record.
In general, analysis populations affect the interpretation of results because exclusions can change the set of participants contributing data. With no analysis records or numerical endpoint result, the extent and consequences of missing outcome data cannot be evaluated. The record also does not report interim analyses or the trial’s statistical plan.
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 |
|---|---|---|---|
| Capecitabine 825 + Pertuzumab 1050 | 0 | 5 | 0.0% |
| Capecitabine 1000 + Pertuzumab 1050 | 1 | 6 | 16.7% |
| Capecitabine 1250 + Pertuzumab 1050 | 1 | 7 | 14.3% |
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 |
|---|---|
| Capecitabine 825 + Pertuzumab 1050 | 5 of 5 |
| Capecitabine 1000 + Pertuzumab 1050 | 6 of 6 |
| Capecitabine 1250 + Pertuzumab 1050 | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Capecitabine 825 + Pertuzumab 1050 | Capecitabine 1000 + Pertuzumab 1050 | Capecitabine 1250 + Pertuzumab 1050 |
|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 0 of 5 | 0 of 6 | 1 of 7 |
| Intestinal Obstruction | Gastrointestinal disorders | 0 of 5 | 1 of 6 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Capecitabine 825 + Pertuzumab 1050 | Capecitabine 1000 + Pertuzumab 1050 | Capecitabine 1250 + Pertuzumab 1050 |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 3 of 5 | 3 of 6 | 7 of 7 |
| Nausea | Gastrointestinal disorders | 4 of 5 | 4 of 6 | 4 of 7 |
| Anorexia | Metabolism and nutrition disorders | 2 of 5 | 3 of 6 | 4 of 7 |
| Asthenia | General disorders | 1 of 5 | 3 of 6 | 4 of 7 |
| Vomiting | Gastrointestinal disorders | 2 of 5 | 3 of 6 | 2 of 7 |
| Mucosal inflammation | General disorders | 0 of 5 | 2 of 6 | 4 of 7 |
| Lethargy | Nervous system disorders | 2 of 5 | 2 of 6 | 2 of 7 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 5 | 2 of 6 | 2 of 7 |
| Pyrexia | General disorders | 0 of 5 | 2 of 6 | 2 of 7 |
| Skin reaction | Skin and subcutaneous tissue disorders | 2 of 5 | 0 of 6 | 2 of 7 |
Serious events with the highest arm-level rate: intestinal obstruction (16.7%), pulmonary embolism (14.3%).
The safety summaries distinguish serious adverse events from other adverse events and report the number at risk and the number affected in each dose-labelled group. For serious adverse events, the counts are 0 affected among 5 at risk for Capecitabine 825 + Pertuzumab 1050, 1 among 6 for Capecitabine 1000 + Pertuzumab 1050, and 1 among 7 for Capecitabine 1250 + Pertuzumab 1050. For other adverse events, the counts are 5 among 5, 6 among 6, and 7 among 7, respectively.
The registry lists Intestinal Obstruction at 16.7% and Pulmonary Embolism at 14.3% among the top serious terms. It does not report dose-group attribution for these percentages in the available record. Death counts are not reported in the registry record.
In general, these are descriptive counts, not adjusted comparisons. Cohort sizes are small, and the record does not provide event timing, duration, exposure-adjusted rates, or information about overlap between events. A count of zero should not be interpreted as proof that an event is impossible, while an event count in a cohort does not establish that dose caused it. The non-randomized design further limits direct comparisons between dose groups.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was an early-phase study of rhuMAb 2C4 with capecitabine in advanced solid tumors, using non-randomized dose cohorts and a toxicity-based maximum tolerated dose question. It reports three capecitabine dose levels and descriptive safety counts, as well as a list of pharmacokinetic outcomes. These details characterize the study’s design and the types of outcomes it intended to assess.
The record does not report the numerical maximum tolerated dose, the percentage of participants with dose-limiting toxicities, or numerical pharmacokinetic results. It also contains no analysis records. Therefore, it does not establish which dose combination was selected under the endpoint definition, how precise that selection was, or what the pharmacokinetic findings were. The serious adverse-event counts and listed serious terms are not substitutes for the missing primary endpoint result.
In general, a dose-finding result and a comparative treatment-effect result answer different questions. Identifying a dose under a toxicity rule does not establish efficacy relative to another treatment. This study had no randomized control group, and the dose cohorts are not a like-for-like comparison. The posted cohort summaries cannot isolate a causal dose effect or establish that one dose is safer or more effective than another.
The listed adverse events describe what was recorded in the available summaries, but the information does not provide a full account of event timing, severity distributions, participant-level overlap, or follow-up exposure. Nor does it report deaths. Absence of those details limits the scope of safety interpretation. In general, small descriptive cohorts can identify observed events but cannot rule out uncommon events or settle comparative risk questions.
Accordingly, the registry supports a description of the trial’s purpose, dose levels, endpoint definition, and reported safety counts. It does not support a conclusion about clinical benefit, a definitive comparative safety ranking, or the precision of a selected maximum tolerated dose. Those questions require results and analyses that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically instructive because its primary question concerns dose selection rather than a treatment-versus-control effect. The distinction determines what the design can answer. Escalating-dose cohorts can be organized to assess tolerability under a toxicity rule, while a randomized control comparison is designed for a different inferential target. Here, allocation was non-randomized and the cohorts were not a like-for-like control comparison.
The registry’s endpoint definition illustrates why operational details matter in early-phase research. It specifies a cycle for evaluation, lists toxicity criteria, and explains that some participants who leave early for reasons other than dose-limiting toxicity are not evaluable for that endpoint. Those rules affect which observations count toward a dose-finding decision. Yet the registry does not report the numerical endpoint result or the number evaluable, so the study’s decision cannot be reconstructed from the record.
The adverse-event summaries also illustrate the limits of small descriptive groups. Counts should be interpreted alongside the number at risk, and not as proof of a dose relationship. General statistical reasoning cautions that sparse data offer limited precision, especially for uncommon events. Without randomized allocation, adjustment, or detailed participant-level information, observed differences between cohorts cannot be separated from differences in who entered each cohort or how they were observed.
Finally, the record makes the distinction between an intended outcome and an analyzed result visible. It lists 12 outcome measures but no analysis records, and several pharmacokinetic measures are named without numerical results. This underscores that outcome definitions alone do not provide evidence about the observed endpoint. A sound statistical reading separates the design question, the data reported, and the conclusions the available analyses can support.
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 trial-specific limitation is the absence of a reported numerical maximum tolerated dose result, despite that endpoint being the primary outcome. The record describes the dose-limiting toxicity criteria and evaluation period, but does not report the number of participants evaluable for the endpoint, the dose-specific dose-limiting toxicity results, or the decision selecting a maximum tolerated dose. The primary question therefore cannot be answered from the registry record.
Enrollment was 19 across three non-randomized, open-label dose-labelled groups. The registry does not report participant characteristics by group, the allocation process in sufficient detail, or a randomized control group. As a result, direct causal contrasts between dose groups are not supported. The study was designed around dose finding and safety, and its structure does not provide a like-for-like comparison for estimating a treatment effect.
Safety reporting is also limited in the available record. It gives at-risk and affected counts, but does not provide exposure-adjusted rates, event timing, duration, or detailed participant-level information. The listed serious terms are not assigned to specific dose groups here, and death counts are not reported in the registry record. These omissions restrict assessment of event patterns and their uncertainty.
The pharmacokinetic outcomes are named but their numerical results and analysis methods are not reported. The record lists 12 outcome measures but 0 analysis records, and does not report the statistical analysis plan, interim analyses, missing-data procedures, or trial-specific sample-size justification. The arm descriptions are truncated, so the complete regimen details are not available. Together, these reporting gaps limit reproducibility and prevent a full assessment of endpoint precision, analysis choices, or the study’s conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors — NCT02494596.
- Registry record last updated 2015-11-10; status last verified 2015-10.
- Results first posted 2015-09-30.
- 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
NCT02494596 was a completed Phase Ib, open-label, multicenter study recorded as Phase 1. It enrolled 19 participants with advanced solid tumors and examined rhuMAb 2C4 with capecitabine in non-randomized dose cohorts. The listed capecitabine dose levels were 825 mg/m^2, 1000 mg/m^2, and 1250 mg/m^2. The primary outcome was the maximum tolerated dose of the combination during Cycle 1 (3 Weeks), defined using dose-limiting toxicities.
The registry reports descriptive serious and other adverse-event counts across three dose-labelled groups. It lists pharmacokinetic outcomes but does not report their numerical results. Although 12 outcome measures are listed, 0 analysis records are present. The numerical maximum tolerated dose, statistical analysis plan, and trial-specific sample-size justification are not reported in the registry record. The non-randomized dose cohorts do not constitute a like-for-like control comparison, so the posted information supports descriptive interpretation rather than a randomized treatment-effect estimate.