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 PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors (NCT00940498), a registered phase 1 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00940498 |
| Phase | Phase 1 |
| Condition | Neoplasms |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | None (open label) |
| Enrollment | 78 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled people with solid tumors. Its safety analysis set included participants who received at least 1 dose of study medication. The record describes an initial part involving people with any solid tumor and later cohorts with specified tumor types or biopsy participation.
Intervention
Participants received intravenous PF-05212384, also known as PKI-587. The record lists dose groups from 10 mg through 319 mg, including a group designated for Parts 1 and 2 at 154 mg.
Comparator
No randomized control group is identified. Allocation is not stated, and the dose groups are not a like-for-like control comparison. The record therefore does not support interpreting the groups as randomized alternatives.
Primary question
The primary outcome counts participants with treatment-emergent adverse events or serious adverse events from baseline up to Cycle 14, with each cycle lasting 28 days. Part 1 was intended to identify the maximum tolerated dose using a continual reassessment method. The record also describes later cohorts for safety, tolerability, preliminary efficacy, and tumor biopsies; posted results for those aims are not included in the registry record.
3. Trial Design
This was a phase 1 study of intravenous PF-05212384 (also known as PKI-587) in people with solid tumors. The registry lists the study as completed, with enrollment of 78. The listed start is 2010-01 and the primary completion is 2011-08. Masking is listed as none, so the study was open-label. Allocation is not stated.
The brief summary describes a two-part design. Part 1 was intended to identify the maximum tolerated dose using a continual reassessment method, or CRM, in people with any solid tumor. The record lists dose groups at 10 mg, 21 mg, 43 mg, 89 mg, 154 mg, 222 mg, 266 mg, and 319 mg. The 154 mg group is designated as including both Part 1 and Part 2.
The summary describes two Part 2 cohorts: one to assess safety, tolerability, and preliminary efficacy at the maximum tolerated dose in specified tumor types, and another for participants with any tumor who agreed to provide tumor biopsies. The planned cohort descriptions do not establish how many participants were actually enrolled in each cohort. Actual cohort enrollment and the selected maximum tolerated dose are not reported in the registry record.
The design is not a randomized comparison. The registry does not identify a concurrent control arm, and different dose groups should not be read as equivalent groups assigned to competing treatments. The posted event counts are descriptive by dose group; they do not by themselves isolate a dose effect from differences in the participants or study conduct.
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: The study was conducted in two parts: Part 1 to determine the maximum tolerated dose (MTD) and Part 2 to confirm the MTD. As per the sponsor's decision, data was reported for the combined population of Part 1 and Part 2 which was considered more informative.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Part 1: PF-05212384 10 mg | Part 1: PF-05212384 21 mg | Part 1: PF-05212384 43 mg | Part 1: PF-05212384 89 mg | Part 1 and 2: PF-05212384 154 mg | Part 1: PF-05212384 222 mg |
|---|---|---|---|---|---|---|
| STARTED | 4 | 4 | 4 | 4 | 43 | 7 |
| COMPLETED | 1 | 3 | 1 | 2 | 34 | 6 |
| NOT COMPLETED | 3 | 1 | 3 | 2 | 9 | 1 |
Reasons for not completing this period:
| Reason | Part 1: PF-05212384 10 mg | Part 1: PF-05212384 21 mg | Part 1: PF-05212384 43 mg | Part 1: PF-05212384 89 mg | Part 1 and 2: PF-05212384 154 mg | Part 1: PF-05212384 222 mg |
|---|---|---|---|---|---|---|
| Death | 2 | 0 | 0 | 1 | 5 | 0 |
| Lost to Follow-up | 1 | 1 | 2 | 0 | 1 | 0 |
| Disease Progression | 0 | 0 | 1 | 1 | 0 | 1 |
| Physician Decision | 0 | 0 | 0 | 0 | 2 | 0 |
| Not treated due to disease related pain | 0 | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis set included all participants who received at least 1 dose of study medication.
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: Safety analysis set included all participants who received at least 1 dose of study medication.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Part 1: PF-05212384 10 mg | Part 1: PF-05212384 21 mg | Part 1: PF-05212384 43 mg | Part 1: PF-05212384 89 mg | Part 1 and 2: PF-05212384 154 mg | Part 1: PF-05212384 222 mg |
|---|---|---|---|---|---|---|---|
| Participants analysed | 4 | 4 | 4 | 4 | 42 | 7 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 | 3 | 4 | 4 | 34 | 4 |
| Age, Categorical: >=65 years | Participants | 0 | 1 | 0 | 0 | 8 | 3 |
| Sex: Female, Male: Female | Participants | 1 | 3 | 1 | 2 | 20 | 5 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 3 | 2 | 22 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), measured over Baseline up to Cycle 14 (each cycle is 28 days).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-emergent adverse events or serious adverse events. It counts participants, not the total number of event episodes. The registry defines an adverse event as an untoward medical occurrence after a participant received study drug, without requiring a causal relationship to treatment. Serious events are those resulting in specified outcomes, including death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, or congenital anomaly; an event could also be deemed serious for another significant reason.
Treatment-emergent events are defined as events arising between the first dose and up to Cycle 14 that were absent before treatment or worsened relative to the pretreatment state. The stated timeframe begins at baseline and extends up to Cycle 14, with each cycle lasting 28 days. Including serious and non-serious events provides a broad safety count, while the serious-event classification identifies events meeting the registry’s seriousness criteria.
This endpoint is appropriate for describing observed safety events in an early-phase study, but a count does not establish that study drug caused an event. Nor does the endpoint measure tumor response or establish comparative efficacy. The record’s definition and safety population are reported; details of the endpoint analysis beyond the posted counts are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s adverse-event results are organized by dose group. For serious adverse events, the participant counts at risk and affected are 4 and 2 at 10 mg; 4 and 1 at 21 mg; 4 and 1 at 43 mg; 4 and 1 at 89 mg; 42 and 16 at 154 mg; 7 and 0 at 222 mg; 8 and 5 at 266 mg; and 4 and 2 at 319 mg. These are descriptive counts within the listed groups. The groups differ in size, and the record does not identify randomized allocation or a like-for-like control comparison.
For other adverse events, the recorded affected count equals the at-risk count in each listed dose group: 4 at 10 mg, 4 at 21 mg, 4 at 43 mg, 4 at 89 mg, 42 at 154 mg, 7 at 222 mg, 8 at 266 mg, and 4 at 319 mg. These results indicate the number of participants recorded as affected, not the number or severity of individual events. The registry’s primary endpoint combines treatment-emergent adverse events and serious adverse events, while the adverse-event group results separate serious events from other events.
The record lists disease progression as a serious-event term at 50.0%. Abdominal pain, diarrhoea, vomiting, mucosal inflammation, and pneumonia are each listed at 25.0%. These term percentages do not state, on their own, the number of event episodes or the number of participants represented by each term. Their denominator and any rules for counting repeated events are not reported in the registry record. They should not be treated as estimates of causal risk from the drug.
There are no registered analyses listed in the record. No inferential comparison, adjusted estimate, confidence interval, or p-value is reported in the registry record. The counts therefore support a descriptive reading only. In particular, differences in counts across dose groups cannot be interpreted as evidence that one dose caused more or fewer events than another, because the groups are not identified as randomized comparison groups and their composition may differ.
The registry describes a Part 1 dose-finding aim and Part 2 safety and other aims, but the posted information does not report the result of the CRM dose-finding procedure, the selected maximum tolerated dose, or efficacy findings. The numerical safety counts do not answer those questions. Any planning illustrations based on an observed effect are not observed power, and their assumptions do not convert these dose groups into a controlled trial comparison.
9. Statistical Methods Explained
The registry reports counts of participants with events, rather than a model-based treatment effect. The methods below explain how such results are generally interpreted; they are not a description of unreported analyses performed in this study.
What does a participant count represent?
For a binary outcome, each participant is classified according to whether the outcome occurred during the specified observation period. A count of affected participants describes how many met that definition. The at-risk count gives the group size used for that outcome. In this record, serious adverse events and other adverse events are presented separately by dose group. A participant count is not an event count: a participant may have experienced more than one event, but a count of participants affected does not convey the number of episodes.
The outcome definition matters. The primary endpoint includes treatment-emergent adverse events or serious adverse events, and treatment-emergent status depends on timing and comparison with the pretreatment state. The registry also explains what qualifies as an adverse event and a serious adverse event. Those definitions determine which observations contribute to the endpoint; they do not establish that an event was caused by treatment.
What can a confidence interval add?
General statistical explanation: a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the method used. It can show whether a result is compatible with a range of values, rather than presenting only a single estimate. An interval’s interpretation depends on the estimand, analysis population, and method. The registry record does not report confidence intervals for the posted adverse-event counts, so their precision cannot be assessed through an interval estimate in the registry record.
Why is this not a randomized dose comparison?
The registry identifies dose groups but does not report randomized allocation or a control arm. Counts across groups can be described, but a direct comparison would require assumptions about how the groups were formed and whether they were comparable. Those details are not reported in the registry record. The counts should therefore not be interpreted as a causal contrast between doses. The study’s stated Part 1 aim was dose finding using a continual reassessment method; the record does not report the fitted model, its operating details, or the resulting dose-selection analysis.
What does over-dispersion mean in general?
General statistical explanation: over-dispersion occurs when observed variability in data is greater than a model expects. It is a concern for some count-data models, particularly when event counts vary substantially between participants. A model that ignores extra variability can produce uncertainty estimates that are too small. The posted primary endpoint is a participant count for a binary event status, not a reported recurrent-event count model. No over-dispersion assessment or count-model analysis is reported in the registry record, so it should not be attributed to this study.
How should planning illustrations be read?
The stated sample-size assumptions describe planning illustrations based on an observed effect, not the trial’s own design. They use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such calculations are hypothetical planning exercises, not observed power. The registry does not describe a randomized two-arm comparison, and the listed dose groups are not a like-for-like control comparison. The illustrations therefore should not be read as evidence that the study had a particular probability of detecting a treatment effect or as a reconstruction of its design.
For a binary endpoint, a planning calculation also depends on the assumed event frequency and the effect to be detected. The planning assumptions alone do not establish that those assumptions match the study population or a meaningful comparison. No sample-size justification for the actual study is reported in the registry record. The planning values themselves should be interpreted only as illustrations under their stated assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 18 outcome measures and no registered analyses. Secondary outcomes include pharmacokinetic measures such as maximum observed plasma concentration, area under the curve, and plasma decay half-life, as well as corrected QT interval, serum glucose, and serum insulin measures at multiple visits. The primary outcome concerns participants with treatment-emergent adverse events or serious adverse events. The record does not provide a complete results set for these listed outcomes in the information.
Multiplicity arises when many outcomes, time points, or comparisons are examined. General statistical explanation: as the number of statistical tests increases, the chance of at least one apparently notable result can increase if each test is interpreted separately. Researchers may plan a hierarchy of outcomes or an adjustment procedure, but the approach depends on the analysis plan and scientific question. A multiplicity strategy is not reported in the registry record. No p-values or analysis results are listed, so the effect of multiplicity on inferential claims cannot be assessed.
Missing-data methods are also not reported in the registry record. The record identifies the safety analysis set as participants who received at least 1 dose of study medication, but it does not describe how missing event information, incomplete follow-up, or participants who did not complete the observation period were handled. The stated observation window extends up to Cycle 14; the registry does not provide participant-level follow-up completeness in this record.
The analysis population is therefore defined for safety, but the record does not establish a separate analysis population for every secondary outcome. It also does not report the detailed statistical analysis plan, interim analyses, or sample-size justification. These omissions limit assessment of which results were planned, how repeated outcomes were handled, and how missing observations may have affected the reported summaries.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part 1: PF-05212384 10 mg | 2 | 4 | 50.0% |
| Part 1: PF-05212384 21 mg | 1 | 4 | 25.0% |
| Part 1: PF-05212384 43 mg | 1 | 4 | 25.0% |
| Part 1: PF-05212384 89 mg | 1 | 4 | 25.0% |
| Part 1 and 2: PF-05212384 154 mg | 16 | 42 | 38.1% |
| Part 1: PF-05212384 222 mg | 0 | 7 | 0.0% |
| Part 1: PF-05212384 266 mg | 5 | 8 | 62.5% |
| Part 1: PF-05212384 319 mg | 2 | 4 | 50.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part 1: PF-05212384 10 mg | 4 of 4 |
| Part 1: PF-05212384 21 mg | 4 of 4 |
| Part 1: PF-05212384 43 mg | 4 of 4 |
| Part 1: PF-05212384 89 mg | 4 of 4 |
| Part 1 and 2: PF-05212384 154 mg | 42 of 42 |
| Part 1: PF-05212384 222 mg | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1: PF-05212384 10 mg | Part 1: PF-05212384 21 mg | Part 1: PF-05212384 43 mg | Part 1: PF-05212384 89 mg | Part 1 and 2: PF-05212384 154 mg | Part 1: PF-05212384 222 mg |
|---|---|---|---|---|---|---|---|
| Disease progression | General disorders | 2 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 3 of 42 | 0 of 7 |
| Abdominal pain | Gastrointestinal disorders | 1 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Pain | General disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 2 of 42 | 0 of 7 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 4 | 0 of 4 | 1 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Colonic obstruction | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Gastrointestinal obstruction | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Nausea | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Rectal haemorrhage | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
| Mucosal inflammation | General disorders | 0 of 4 | 0 of 4 | 0 of 4 | 0 of 4 | 1 of 42 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: PF-05212384 10 mg | Part 1: PF-05212384 21 mg | Part 1: PF-05212384 43 mg | Part 1: PF-05212384 89 mg | Part 1 and 2: PF-05212384 154 mg | Part 1: PF-05212384 222 mg |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 3 of 4 | 2 of 4 | 2 of 4 | 1 of 4 | 22 of 42 | 3 of 7 |
| Mucosal inflammation | General disorders | 0 of 4 | 1 of 4 | 1 of 4 | 0 of 4 | 19 of 42 | 5 of 7 |
| Decreased appetite | Metabolism and nutrition disorders | 2 of 4 | 1 of 4 | 2 of 4 | 1 of 4 | 16 of 42 | 3 of 7 |
| Vomiting | Gastrointestinal disorders | 3 of 4 | 1 of 4 | 0 of 4 | 0 of 4 | 15 of 42 | 2 of 7 |
| Fatigue | General disorders | 3 of 4 | 2 of 4 | 2 of 4 | 0 of 4 | 10 of 42 | 3 of 7 |
| Constipation | Gastrointestinal disorders | 0 of 4 | 0 of 4 | 1 of 4 | 0 of 4 | 13 of 42 | 2 of 7 |
| Asthenia | General disorders | 0 of 4 | 1 of 4 | 0 of 4 | 0 of 4 | 14 of 42 | 1 of 7 |
| Diarrhoea | Gastrointestinal disorders | 1 of 4 | 1 of 4 | 0 of 4 | 2 of 4 | 9 of 42 | 2 of 7 |
| Pyrexia | General disorders | 0 of 4 | 2 of 4 | 0 of 4 | 1 of 4 | 11 of 42 | 1 of 7 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1 of 4 | 0 of 4 | 1 of 4 | 0 of 4 | 12 of 42 | 1 of 7 |
Serious events with the highest arm-level rate: disease progression (50.0%), abdominal pain (25.0%), diarrhoea (25.0%), vomiting (25.0%), mucosal inflammation (25.0%).
The serious adverse-event figures give the number of participants at risk and the number affected in each dose group. For example, the 154 mg group lists 42 at risk and 16 affected; the 266 mg group lists 8 at risk and 5 affected. At 222 mg, the record lists 7 at risk and 0 affected. These are observed participant counts, not estimates adjusted for follow-up or differences between groups. The listed groups vary in size and are not identified as randomized comparison groups.
The other-adverse-event counts are also participant counts. Each listed group has an affected count equal to its at-risk count. This does not tell the reader how many separate events occurred, how long each participant was followed, or how severe the non-serious events were. The serious-event terms and percentages are reported separately; their denominator and event-counting rules are not reported in the registry record.
A serious adverse event is a classification based on outcome or significance, not a judgment that the study drug caused the event. The record defines treatment-emergent events by timing and worsening from pretreatment status, and says that causal relationship is not required for an event to count. Death counts are not reported in the registry record. These summaries describe safety observations in the listed groups; they do not establish comparative risk.
12. What the Result Does, and Does Not, Mean
The posted results provide descriptive safety information for participants receiving PF-05212384 across the listed dose groups. They show how many participants were recorded with serious and other adverse events under the registry’s definitions and observation window. The result is a count-based description of events in a phase 1 study, not a randomized estimate of treatment effect.
The record does not establish whether the events were caused by PF-05212384. The adverse-event definition explicitly does not require a causal relationship. Nor do the counts show whether a dose is safer than another: allocation is not stated, no randomized control group is identified, and the dose groups are not a like-for-like comparison. Differences in counts must not be read as causal dose effects.
The record also does not provide an efficacy result. Although the study summary describes a Part 2 cohort for preliminary efficacy, no tumor-response result is included in the registry information. The primary endpoint is a safety outcome, not a measure of clinical benefit. The maximum tolerated dose identified through the planned CRM process is not reported in the registry record.
Precision is difficult to judge because no confidence intervals or inferential analyses are reported. The sizes of the dose groups differ, and a participant count alone does not describe uncertainty, event timing, recurrent events, or follow-up completeness. The listed serious-event terms add descriptive context, but their denominators and event-counting rules are not reported in the registry record.
Accordingly, the findings should be read as a record of observed safety events in the study population, rather than proof of benefit, proof of harm, or evidence for a comparison between doses. They also do not establish how the results would apply beyond the enrolled participants. Questions about causality, comparative safety, efficacy, and the dose-selection result require information not reported in the registry record.
13. Why This Trial Matters Statistically
Early-phase studies often focus on dose finding and safety characterization rather than a randomized efficacy comparison. This study’s stated Part 1 aim was to identify a maximum tolerated dose using a continual reassessment method. Its registry record also describes later cohorts for safety, tolerability, preliminary efficacy, and tumor biopsies. That structure makes it important to distinguish the study’s aims from the results actually reported.
Statistically, the central challenge is that dose groups in a dose-finding study are not automatically comparable groups. Without reported random allocation or a control arm, group-specific counts are descriptive. They can document what was observed in each group, but cannot isolate the effect of dose from differences among participants, exposure, or follow-up. This distinction is particularly important when group sizes differ.
The outcome definition also matters. Counting participants with at least one treatment-emergent event is not the same as counting event episodes or estimating event rates over person-time. The registry’s safety population and event definitions help clarify what the posted counts represent, while the lack of detailed follow-up and missing-data information constrains interpretation.
The record is also useful for showing the boundaries of registry-based conclusions. It lists a broad set of secondary pharmacokinetic and safety measures, but no registered analyses, confidence intervals, or p-values are reported. The stated sample-size assumptions concern planning illustrations and do not describe the study’s design or observed power. These distinctions help prevent descriptive counts or hypothetical calculations from being mistaken for causal evidence.
Overall, the statistical value lies in careful reading of the estimand, population, and design. The reported safety counts are informative as observations within this study, but the registry record does not support broader comparative or efficacy claims.
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 registry record does not report randomized allocation, and no control arm is identified. The listed dose groups therefore do not form a like-for-like control comparison. Their event counts cannot establish a causal dose relationship or comparative safety effect.
The safety results are counts of participants affected. The record does not give event-level details, participant-level follow-up, exposure duration by group, or the handling of repeated events. Death counts are not reported in the registry record. For the listed serious-event terms, the denominator and counting rules are not reported in the registry record, which limits interpretation of the percentages.
Although the study summary describes a dose-finding procedure, the result of the continual reassessment method and the selected maximum tolerated dose are not reported in the registry record. Actual enrollment in the described Part 2 cohorts is also not reported. The efficacy aim is not accompanied by a posted efficacy result in the information.
The registry lists no analyses. It does not report confidence intervals, p-values, an analysis plan, interim analyses, multiplicity methods, or a sample-size justification for the actual study. Missing-data handling and completeness of follow-up are also not reported. The safety analysis set is defined as participants receiving at least 1 dose, but other analysis populations are not described.
These limitations mean the posted information supports descriptive reporting of the recorded safety counts, but not a precise comparative estimate, a causal conclusion, or an assessment of efficacy. They also make it difficult to determine how much uncertainty surrounds the counts and how completely participants were observed through the stated timeframe.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors — NCT00940498.
- Registry record last updated 2018-11-02; status last verified 2018-02.
- Results first posted 2018-11-02.
- 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
NCT00940498 is a completed, open-label phase 1 study of intravenous PF-05212384, also known as PKI-587, in people with solid tumors. The registry lists enrollment of 78, a start of 2010-01, and primary completion in 2011-08. The study summary describes Part 1 dose finding using a continual reassessment method and Part 2 cohorts for safety and other aims.
The primary outcome counts participants with treatment-emergent adverse events or serious adverse events from baseline up to Cycle 14, with each cycle lasting 28 days. The safety analysis set includes participants who received at least 1 dose. Serious and other adverse-event participant counts are listed by dose group, but no randomized control comparison or registered analysis is reported.
The registry does not report confidence intervals, p-values, missing-data methods, the selected maximum tolerated dose, or efficacy results. The posted counts are descriptive and do not establish causation or comparative treatment effects.