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 Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors (NCT00729833), a non-randomized phase 1 study. The primary outcome is Number of Participants With Dose-Limiting Toxicities (DLT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00729833 |
| Phase | Phase 1 |
| Condition | Advanced Cancer, Advanced Solid Tumors |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced cancer or advanced solid tumors. The primary endpoint population is described as participants who started treatment and did not have first-cycle major treatment deviations.
Intervention
Figitumumab, also named CP-751,871, in combination with sunitinib. The study used escalating cohorts, with dose and schedule combinations described in the safety groups.
Comparator
There was no randomized control group. The registry record describes a non-randomized, single-group study, so its cohorts are not like-for-like controls for one another.
Primary question
How many participants experienced dose-limiting toxicities from baseline through the end of Cycle 1, with each cycle lasting 3 weeks?
The study's stated purpose was to assess the maximum tolerated dose, safety and tolerability, and pharmacokinetic profile of figitumumab and sunitinib when given together to participants with advanced solid tumors. Its primary endpoint counted participants with treatment-related Grade 3/4 toxicities during the defined period, or toxicities that led to a delay of at least 7 days in administration of Cycle 2. Toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0.
This is a dose-escalation question, not a comparative efficacy question. In general, early-phase dose-escalation studies examine tolerability across dose cohorts to inform decisions about dose and schedule. The registry record describes escalating cohorts, but does not report the decision rules used to escalate or select a dose. It also does not report a numerical primary-endpoint result, so the number of participants meeting the dose-limiting toxicity definition cannot be established from the record summarized in the posted results.
The record includes secondary safety and pharmacokinetic outcomes, including treatment-emergent adverse events, laboratory abnormalities, and measures of drug concentration and exposure. Those outcomes broaden the study's stated assessment beyond the primary toxicity count. They do not, by themselves, provide evidence from a randomized comparison, and the registry record does not report a primary endpoint estimate that could be interpreted as a frequency of dose-limiting toxicity.
3. Trial Design
This was a phase 1, open-label, non-randomized, single-group study of CP-751,871, also called figitumumab, combined with sunitinib. The study title identifies advanced solid tumors as the population of interest. The registry record lists an enrollment of 45 and gives the study status as terminated. The recorded start is 2008-09 and primary completion is 2011-08.
The combination was administered in escalating cohorts. The safety groups describe figitumumab 10 mg/kg with sunitinib 25 mg CDD, figitumumab 10 mg/kg with sunitinib 37.5 mg CDD, figitumumab 20 mg/kg with sunitinib 25 mg CDD, and figitumumab 20 mg/kg with sunitinib 25 mg on Schedule 2/1. These are the recorded group labels; the registry record does not provide a detailed explanation of the CDD abbreviation or the scheduling rationale.
Open-label means the study is recorded as having no masking. Non-randomized allocation means participants were not assigned to treatment groups by random allocation, and a single-group model does not establish a randomized control arm. In general, this structure can support descriptive assessment of tolerability within treated cohorts, but it does not control for differences that might arise from participant characteristics, treatment selection, or time. The registry record does not report a protocol-level account of cohort assignment or escalation decisions.
The primary endpoint covers baseline through the end of Cycle 1, with each cycle lasting 3 weeks. The record defines the analysis population as participants who started treatment and did not have first-cycle major treatment deviations. It does not report the number included in that population or the numeric count meeting the endpoint.
The stated secondary outcomes include treatment-emergent adverse events graded under NCI CTC Version 3.0, hematologic and blood chemistry laboratory abnormalities, and pharmacokinetic measures for figitumumab and sunitinib. The registry record reports 15 outcome measures and 0 analyses. It does not report a statistical analysis plan, planned interim analyses, a sample-size justification, or details explaining why the study was terminated.
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 | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| STARTED | 20 | 7 | 12 | 6 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 20 | 7 | 12 | 6 |
Reasons for not completing this period:
| Reason | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Death | 5 | 1 | 3 | 5 |
| Study Terminated by Sponsor | 0 | 0 | 1 | 0 |
| Lost to Follow-up | 1 | 0 | 0 | 0 |
| Withdrawal by Subject | 3 | 1 | 3 | 0 |
| Unspecified Reasons | 11 | 5 | 5 | 1 |
Analysis population for the primary outcome, as defined in the registry: Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.
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: Full Analysis Set: All enrolled participants who received at least 1 dose of figitumumab plus sunitinib.
| Characteristic | Unit | Figitumumab + Sunitinib (All Combined) |
|---|---|---|
| Participants analysed | 45 | |
| Age, Customized: 18 to 44 years | participants | 11 |
| Age, Customized: 45 to 64 years | participants | 22 |
| Age, Customized: Greater than or equal to (>=) 65 years | participants | 12 |
| Sex: Female, Male: Female | Participants | 25 |
| Sex: Female, Male: Male | Participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Dose-Limiting Toxicities (DLT), measured over Baseline up to the end of Cycle 1 (each cycle=3 weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with dose-limiting toxicities (DLT), assessed from baseline through the end of Cycle 1. Each cycle is defined as 3 weeks. A participant met the registry definition through a treatment-related Grade 3/4 toxicity during that interval, or a toxicity resulting in at least 7 days of delay in administration of Cycle 2. The toxicity grading system was the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0.
In general, an early-cycle toxicity endpoint is used in dose-escalation research because tolerability during initial treatment can inform whether a tested dose or schedule merits further evaluation. A count of affected participants is a descriptive measure: it states how many people in the defined population met the endpoint. It does not express the severity or duration of every event, and the count alone does not show whether a toxicity was caused by treatment beyond the attribution specified in the endpoint definition.
The registry record identifies the endpoint and its assessment window, but the numeric primary endpoint result is not reported in the registry record. The denominator for the endpoint analysis is also not reported in the registry record. Therefore, the record summarized in the posted results does not support describing the observed DLT count or the proportion of the analysis population affected.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a phase 1 dose-escalation study of figitumumab and sunitinib in advanced solid tumors. Its design and primary question focus on toxicity and tolerability during the first treatment cycle, alongside pharmacokinetic assessment. The registry entries do not include a numerical result for the primary endpoint. Accordingly, the number of participants with dose-limiting toxicities, and the proportion of the defined analysis population with such toxicities, are not reported in the registry record.
The record does include serious adverse event group counts. For figitumumab 10 mg/kg plus sunitinib 25 mg CDD, 10 participants are recorded as affected by serious adverse events among 20 at risk. For figitumumab 10 mg/kg plus sunitinib 37.5 mg CDD, 3 are recorded as affected among 7 at risk. For figitumumab 20 mg/kg plus sunitinib 25 mg CDD, 6 are recorded as affected among 12 at risk. For figitumumab 20 mg/kg plus sunitinib 25 mg Schedule 2/1, 5 are recorded as affected among 6 at risk. These group summaries concern serious adverse events, not the specifically defined primary DLT endpoint. The record does not establish that every serious adverse event met the DLT definition.
The listed leading serious adverse event terms include Disease progression at 50.0%, and Abdominal pain, Small intestinal perforation, Hyperglycaemia, Renal failure, and Ureteric obstruction, each at 16.7%. The denominator and counting convention for these term percentages are not reported in the registry record. The percentages should therefore be read as registry-listed summaries, not as estimates with a known denominator or as comparisons between dose groups.
There was no randomized comparator. The cohorts also differ in dose or schedule, and the record does not describe randomized allocation between them. Consequently, differences in the group counts cannot be attributed to the dose or schedule alone. In general, cohort counts from a dose-escalation study are descriptive and may be affected by group size and participant mix. They do not establish a causal contrast.
The registry record reports 45 enrolled participants, while the serious adverse event groups list 20, 7, 12, and 6 participants at risk. The primary endpoint population is described by eligibility criteria, but its analyzed number is not reported in the registry record. Enrollment and endpoint-analysis population are distinct quantities; the record does not explain the relationship between enrollment, cohort membership, and the population contributing to each outcome.
Precision cannot be assessed for the primary endpoint because its result and an uncertainty interval are not reported. More generally, a count without an uncertainty interval provides limited information about how precisely an underlying event frequency has been estimated. No confidence interval or inferential analysis for the outcomes is reported in the registry record. The posted information supports description of the design, endpoint definition, and listed safety counts, but not a conclusion about the frequency of DLT or a comparative effect of the combination.
9. Statistical Methods Explained
General explanation: A phase 1 dose-escalation study typically evaluates tolerability and may assess pharmacokinetics while testing dose or schedule combinations. The registry record describes escalating cohorts and states that the study sought to determine maximum tolerated dose, overall safety and tolerability, and pharmacokinetic profile. It does not report the specific escalation rules, dose-selection algorithm, or protocol used to make those decisions. Those details should not be inferred from the cohort labels alone.
General explanation of the primary endpoint: The primary outcome is a participant count, rather than a continuous measurement or time-to-event measure. It counts participants meeting the registry's composite DLT definition during the specified window: treatment-related Grade 3/4 toxicity, or toxicity causing at least 7 days of delay in Cycle 2. Combining criteria can capture more than one type of clinically relevant treatment disruption, but interpretation depends on applying the definition consistently. The registry record does not provide the observed count or additional detail about endpoint adjudication.
General explanation of analysis populations: An analysis population defines which participants contribute to an endpoint estimate. The record specifies a Per-Protocol Analysis Set comprising participants who started treatment and had no first-cycle major treatment deviations. That definition is relevant because not every enrolled participant necessarily contributes to every analysis. The number in this endpoint population is not reported in the registry record. The record also does not define “major treatment deviations” in further detail or state how any participants outside the stated set were handled.
General explanation of counts and uncertainty: A count describes the observed number of participants meeting an outcome definition in a particular group. A proportion requires both the count and the relevant denominator. An uncertainty interval, such as a confidence interval, describes the range of values reasonably compatible with the observed data under the method used. It does not guarantee that the true value lies within that interval, and its interpretation depends on the model and assumptions. No primary endpoint estimate, denominator, or confidence interval is reported in the registry record, so no such estimate or precision statement can be reproduced.
General explanation of over-dispersion: Over-dispersion matters when count data vary more than a chosen statistical model expects. If it is ignored, uncertainty can be understated and statistical conclusions can become too confident. This issue is more relevant when a suitable count model is used; the primary endpoint is defined as a participant count, and no model-based analysis is reported in the registry record. It would be inappropriate to claim that over-dispersion was assessed or that any particular count model was used.
General explanation of comparisons: Random allocation helps balance measured and unmeasured participant characteristics on average, supporting causal comparisons between treatment groups. This study is recorded as non-randomized and single-group, and the safety group labels represent different dose or schedule cohorts rather than randomized control arms. Comparisons across these cohorts can describe observed counts, but they cannot isolate the effect of dose or schedule from other differences. The registry record explicitly cautions that the arms are not a like-for-like control comparison.
General explanation of multiplicity: When many outcomes or statistical tests are examined, the chance of finding an apparently notable result by chance can increase. Methods such as prespecifying a primary endpoint or adjusting for multiple tests can address particular multiplicity concerns. The record lists one primary outcome and numerous secondary outcome measures, but does not report a multiplicity strategy or the results of statistical tests. It also reports 0 analyses. The statistical plan, including whether any adjustment was intended, is not reported in the registry record.
General explanation of sample-size planning: A sample-size calculation depends on a target effect, variability assumptions, significance level, power, allocation, and analysis method. Planning illustrations are not observed power and do not state what the trial actually achieved. The described planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect expressed as a fraction of the observed effect; time-to-event illustrations use a total event count, while other illustrations use participants per arm. These are planning conventions, not evidence that this study had two randomized arms. The trial is recorded as non-randomized and single-group, and its own sample-size justification is not reported in the registry record.
General explanation of pharmacokinetics: Pharmacokinetic measures describe drug concentrations and exposure over time. The listed outcomes include figitumumab concentration at the end of infusion, area under the concentration curve over specified intervals, its plasma decay half-life, and maximum observed plasma concentration of sunitinib. These measures address drug disposition, not a direct comparative treatment effect. Numeric pharmacokinetic results are not included in the registry record for this analysis, so their values and precision are not reported in the registry record.
General explanation of statistical significance: A p-value, when reported, measures how compatible data are with a specified null model under its assumptions; it is not the probability that the null hypothesis is true. Statistical significance does not establish clinical importance, and absence of a reported test does not establish absence of an effect. The record reports no analyses, p-values, or inferential estimates. Thus, no formal statistical significance conclusion can be drawn from the posted information.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | 20 | 0 | 0.0% | 0.0% to 16.8% | 0.0% to 16.1% | 0.1% to 16.1% |
| Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | 7 | 1 | 14.3% | 0.4% to 57.9% | 2.6% to 51.3% | 3.2% to 52.7% |
| Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | 12 | 3 | 25.0% | 5.5% to 57.2% | 8.9% to 53.2% | 9.1% to 53.8% |
| Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/ | 6 | 1 | 16.7% | 0.4% to 64.1% | 3.0% to 56.4% | 3.7% to 57.9% |
R code and output
arm <- c("Figitumumab 10 mg/kg + Sunitinib 25 mg CDD", "Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD", "Figitumumab 20 mg/kg + Sunitinib 25 mg CDD", "Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/")
n <- c(20, 7, 12, 6)
events <- c(0, 1, 3, 1)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Figitumumab 10 mg/kg + Sunitinib 25 mg CDD 20 0 0.0 0.0 16.8 0.0 16.1 0.1 16.1
ARM Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD 7 1 14.3 0.4 57.9 2.6 51.3 3.2 52.7
ARM Figitumumab 20 mg/kg + Sunitinib 25 mg CDD 12 3 25.0 5.5 57.2 8.9 53.2 9.1 53.8
ARM Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/ 6 1 16.7 0.4 64.1 3.0 56.4 3.7 57.911. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary endpoint and multiple secondary outcomes. The secondary outcomes cover treatment-emergent adverse events, hematologic and blood chemistry laboratory abnormalities, and pharmacokinetic measures for figitumumab and sunitinib. Examining many outcomes can raise multiplicity concerns: when several tests are conducted, some results may appear unusual by chance even if no corresponding underlying effect exists. General approaches include defining a primary outcome in advance, distinguishing confirmatory from exploratory analyses, and using an adjustment when appropriate. The record does not report whether any multiplicity strategy was planned or used.
The record reports 0 analyses. It does not provide a statistical analysis plan, p-values, confidence intervals, or a numeric primary endpoint result. The statistical test or estimation method for the primary outcome is not reported in the registry record. It is therefore not possible to assess whether analyses were prespecified, whether the reported outcomes were selected after data review, or how any multiplicity issue was handled.
The primary endpoint population is described as participants who started treatment and did not have first-cycle major treatment deviations. Its size is not reported in the registry record. The record does not report missing-data counts, reasons for missingness, imputation methods, or sensitivity analyses. Missingness can affect interpretation if participants with unavailable outcomes differ systematically from those with observed outcomes; this is a general concern, not a claim about what occurred in this study.
The enrollment figure is 45, but enrollment alone does not identify the number analyzed for each endpoint. The adverse event groups have their own at-risk counts, while the primary endpoint analysis denominator is not reported. The registry record also does not describe how participants who discontinued, did not complete the assessment window, or had protocol deviations were handled for secondary outcomes. These omissions limit assessment of the completeness and comparability of outcome data.
12. 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 |
|---|---|---|---|
| Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | 10 | 20 | 50.0% |
| Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | 3 | 7 | 42.9% |
| Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | 6 | 12 | 50.0% |
| Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 | 5 | 6 | 83.3% |
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 |
|---|---|
| Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | 20 of 20 |
| Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | 7 of 7 |
| Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | 12 of 12 |
| Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|---|
| Disease progression | General disorders | 5 of 20 | 0 of 7 | 2 of 12 | 3 of 6 |
| Deep vein thrombosis | Vascular disorders | 0 of 20 | 1 of 7 | 1 of 12 | 1 of 6 |
| Pericardial effusion | Cardiac disorders | 1 of 20 | 0 of 7 | 1 of 12 | 0 of 6 |
| Abdominal pain | Gastrointestinal disorders | 1 of 20 | 0 of 7 | 0 of 12 | 1 of 6 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 20 | 1 of 7 | 1 of 12 | 0 of 6 |
| Vomiting | Gastrointestinal disorders | 1 of 20 | 0 of 7 | 1 of 12 | 0 of 6 |
| Pain | General disorders | 2 of 20 | 0 of 7 | 0 of 12 | 0 of 6 |
| Anaemia | Blood and lymphatic system disorders | 1 of 20 | 0 of 7 | 0 of 12 | 0 of 6 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 20 | 0 of 7 | 0 of 12 | 0 of 6 |
| Cardio-respiratory arrest | Cardiac disorders | 1 of 20 | 0 of 7 | 0 of 12 | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|---|
| Fatigue | General disorders | 14 of 20 | 6 of 7 | 9 of 12 | 5 of 6 |
| Diarrhoea | Gastrointestinal disorders | 12 of 20 | 5 of 7 | 7 of 12 | 2 of 6 |
| Dysgeusia | Nervous system disorders | 12 of 20 | 4 of 7 | 3 of 12 | 0 of 6 |
| Nausea | Gastrointestinal disorders | 5 of 20 | 4 of 7 | 4 of 12 | 4 of 6 |
| Thrombocytopenia | Blood and lymphatic system disorders | 7 of 20 | 6 of 7 | 2 of 12 | 0 of 6 |
| Anaemia | Blood and lymphatic system disorders | 7 of 20 | 5 of 7 | 1 of 12 | 0 of 6 |
| Decreased appetite | Metabolism and nutrition disorders | 4 of 20 | 2 of 7 | 3 of 12 | 2 of 6 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 3 of 20 | 5 of 7 | 3 of 12 | 0 of 6 |
| Skin discolouration | Skin and subcutaneous tissue disorders | 7 of 20 | 3 of 7 | 1 of 12 | 0 of 6 |
| Vomiting | Gastrointestinal disorders | 4 of 20 | 1 of 7 | 4 of 12 | 1 of 6 |
Serious events with the highest arm-level rate: disease progression (50.0%), abdominal pain (16.7%), small intestinal perforation (16.7%), hyperglycaemia (16.7%), renal failure (16.7%).
The serious adverse event summaries give, for each dose or schedule group, the number at risk and the number recorded as affected. The recorded figures are 10 affected among 20 at risk for figitumumab 10 mg/kg plus sunitinib 25 mg CDD; 3 among 7 for figitumumab 10 mg/kg plus sunitinib 37.5 mg CDD; 6 among 12 for figitumumab 20 mg/kg plus sunitinib 25 mg CDD; and 5 among 6 for figitumumab 20 mg/kg plus sunitinib 25 mg Schedule 2/1.
These are serious adverse event summaries, not the primary DLT count. A serious adverse event and a dose-limiting toxicity are distinct definitions; the registry record does not establish that all serious events met the primary endpoint criteria. The listed serious-event terms include Disease progression at 50.0%, and Abdominal pain, Small intestinal perforation, Hyperglycaemia, Renal failure, and Ureteric obstruction at 16.7% each. The denominator and method used to calculate these term percentages are not reported in the registry record.
In general, small groups can make descriptive percentages sensitive to a change in a small number of participants. These cohorts are non-randomized and are not like-for-like controls, so their counts should not be interpreted as evidence that one dose or schedule caused more or fewer events than another. The deaths field is null for each group; a death count is not reported in the registry record.
13. What the Result Does, and Does Not, Mean
The registry record establishes the study's stated purpose, design, endpoint definition, and selected safety summaries. It describes a phase 1, open-label, non-randomized, single-group evaluation of figitumumab with sunitinib in advanced solid tumors, using escalating cohorts. Its primary outcome was the number of participants with treatment-related Grade 3/4 toxicity during the first cycle or toxicity that caused a delay of at least 7 days in Cycle 2. This definition identifies what the study intended to count, but the numeric count itself is not reported in the registry record.
The serious adverse event figures provide descriptive counts by recorded cohort, and the listed terms identify events appearing in the serious-event summaries. Those figures do not provide a randomized comparison, do not establish a dose-response relationship, and do not substitute for the missing primary DLT result. Without the denominator and counting convention for the event-term percentages, their precise interpretation is also limited.
The record does not support a conclusion about efficacy. The stated aims concern maximum tolerated dose, safety, tolerability, and pharmacokinetic profile; no efficacy result is included in the registry record for this analysis. The listed pharmacokinetic outcomes likewise do not have numeric results in the record. No treatment benefit or absence of benefit can be inferred from these omissions.
More generally, an early-phase safety study can characterize observed events in the treated participants, but its results apply directly only to the study population, treatment conditions, and outcome definitions used. Non-randomized cohort differences may reflect factors other than the dose or schedule. The record does not provide enough detail to estimate uncertainty for the primary outcome or to establish a causal effect.
The most defensible reading is therefore limited: the registry records a dose-escalation safety and pharmacokinetic study, reports serious adverse event counts for its cohorts, and defines a primary DLT endpoint. It does not report the primary endpoint result, its analysis denominator, inferential estimates, or a statistical analysis plan. Those omissions prevent a complete statistical assessment of the primary question.
14. Why This Trial Matters Statistically
This trial is statistically instructive because it illustrates the distinction between defining an endpoint and reporting its result. The registry record provides a specific primary DLT definition, assessment window, grading standard, and analysis-population description. Those details are necessary for interpreting an estimate, but they cannot replace the estimate itself. Without the endpoint count and denominator, the primary outcome cannot be quantified.
The design also highlights why cohort labels should not be mistaken for randomized comparisons. The study is non-randomized and single-group, with escalating cohorts that differ in dose or schedule. The registry record explicitly notes that the arms are not a like-for-like control comparison. Descriptive group counts can summarize what was recorded within each cohort, but a difference between cohorts would not by itself identify a dose effect.
The record further separates a primary toxicity endpoint from broader safety reporting. Serious adverse events are summarized by group, while the primary endpoint uses a distinct definition based on treatment-related Grade 3/4 toxicity or treatment delay. Keeping these definitions separate prevents a common interpretive error: treating every safety count as though it measured the same event construct.
Finally, the record demonstrates how missing analysis details constrain statistical interpretation. The number enrolled is listed, but the primary analysis denominator, missing-data handling, statistical methods, multiplicity approach, and sample-size justification are not reported in the registry record. These details affect how precision, representativeness, and the strength of conclusions can be assessed. The study can therefore be described accurately at the level of its design and definitions, while its primary statistical result remains unquantified in the posted information.
15. 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 central limitation is that the numeric result for the primary DLT endpoint is not reported in the registry record. The endpoint analysis denominator is also not reported. Although enrollment is recorded as 45, that figure does not establish how many participants contributed to the primary outcome or each secondary outcome.
The study is non-randomized, open-label, and recorded as single-group. The dose and schedule cohorts are not randomized controls, so their observed safety counts cannot be interpreted as causal comparisons. The record does not describe cohort assignment procedures, escalation rules, or the criteria used to select a dose or schedule.
The serious adverse event term percentages are listed without a reported denominator or counting convention. The deaths field is null for the recorded groups, and a death count is not reported in the registry record. The relation between serious adverse events, treatment-emergent adverse events, and the primary DLT definition is not fully detailed beyond the stated endpoint criteria.
The record does not report confidence intervals, p-values, analysis methods, handling of missing observations, protocol deviations beyond the primary population description, or a statistical analysis plan. It does not report a sample-size justification or planned interim analyses. The reason for the terminated status is not reported in the registry record. These absences limit assessment of precision, analysis conduct, and the reasons the study ended; they do not establish that a particular method or event did or did not occur.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors — NCT00729833.
- Registry record last updated 2014-06-09; status last verified 2014-05.
- Results first posted 2014-06-09.
- 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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19. Record Summary
The registry record describes NCT00729833, a phase 1, open-label, non-randomized, single-group study of CP-751,871, also called figitumumab, with sunitinib in participants with advanced solid tumors. The study used escalating cohorts and was intended to assess maximum tolerated dose, safety and tolerability, and pharmacokinetics. Enrollment is recorded as 45; status is terminated. The recorded start is 2008-09 and primary completion is 2011-08.
The primary endpoint counts participants with treatment-related Grade 3/4 toxicity during baseline through the end of Cycle 1, or toxicity causing at least 7 days of delay in Cycle 2. The registry record does not report the numeric result or analysis denominator for that endpoint. Serious adverse event counts are reported for four dose or schedule groups, but those groups are not randomized controls. The record lists 15 outcome measures and 0 analyses; a statistical analysis plan, sample-size justification, missing-data methods, and multiplicity approach are not reported in the registry record.