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 An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) (NCT02997176), a non-randomized phase 1 study. The primary outcome is Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02997176 |
| Phase | Phase 1 |
| Condition | Advanced Solid Tumors |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced solid tumors and normal hepatic function or varying degrees of hepatic impairment. The registry record reports enrollment of 38 participants. The primary pharmacokinetic analysis population was defined by Day 22 completion and dosing and adherence criteria; the full description of those criteria is not reported in the registry record.
Intervention
Talazoparib, an oral drug identified in the registry record as the study intervention. The primary endpoint description refers to participants receiving a daily dose of 0.5 mg immediately before the Day 22 visit, subject to its stated eligibility criteria.
Comparator
Participants were grouped by hepatic function: normal function, mild impairment, moderate impairment, or severe impairment. The normal hepatic function group is designated as a control, but allocation was non-randomized. These groups therefore do not form a randomized, like-for-like treatment comparison.
Primary question
How does talazoparib exposure, measured as the free-plasma area under the concentration-time curve from zero to 24 hours on Day 22, vary across the hepatic-function groups? The registry record defines this endpoint but does not report group-specific numerical results, estimates of between-group differences, or confidence intervals.
3. Trial Design
NCT02997176, titled “An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800),” was a Phase I study sponsored by Pfizer. Its official title describes a pharmacokinetics and safety study in patients with advanced solid tumors and normal or varying degrees of hepatic impairment. The registry record lists the study as completed, with enrollment of 38. The recorded start date is 2016-09-30, and the primary completion date is 2020-02-12.
The study was open-label, with no masking, and used a parallel design. Allocation was non-randomized. Participants were categorized according to hepatic function: normal, mild impairment, moderate impairment, or severe impairment. The normal-function group was called the control group in the arm description, but it was not a randomized control group. Differences between these groups could reflect differences in participant characteristics or disease as well as hepatic function; the registry record does not provide an adjusted comparison that would separate these possibilities.
The study intervention was talazoparib. The primary outcome was a pharmacokinetic measure on Day 22. Secondary outcomes covered additional measures of total and unbound talazoparib exposure and concentration, including measurements on Day 1 and trough concentrations on Day 8, Day 15, and Day 22. The registry lists 32 outcome measures and 20 analyses. It does not report numerical results for the primary endpoint in the record summarized for this analysis.
This design addresses pharmacokinetics and safety across hepatic-function categories. It does not, on the information reported in the registry record, provide a randomized estimate of comparative treatment benefit. The study’s completion status indicates that the registry lists it as completed; completion alone does not establish that every planned analysis was reported.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participants with advanced solid tumors and impaired hepatic function were enrolled. Participants were assigned to 1 of the 4 groups based on their hepatic function as per the national cancer institute organ dysfunction working group (NCI-ODWG) classification.
Overall Study
| Stage | Talazoparib: Normal Hepatic Function | Talazoparib: Mild Hepatic Impairment | Talazoparib: Moderate Hepatic Impairment | Talazoparib: Severe Hepatic Impairment |
|---|---|---|---|---|
| STARTED | 7 | 10 | 5 | 16 |
| COMPLETED | 6 | 8 | 3 | 5 |
| NOT COMPLETED | 1 | 2 | 2 | 11 |
Reasons for not completing this period:
| Reason | Talazoparib: Normal Hepatic Function | Talazoparib: Mild Hepatic Impairment | Talazoparib: Moderate Hepatic Impairment | Talazoparib: Severe Hepatic Impairment |
|---|---|---|---|---|
| Adverse Event | 0 | 0 | 0 | 8 |
| Progressive Disease | 1 | 0 | 1 | 1 |
| Death | 0 | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 2 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic (PK) evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.
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 any amount of talazoparib.
| Characteristic | Unit | Talazoparib: Normal Hepatic Function | Talazoparib: Mild Hepatic Impairment | Talazoparib: Moderate Hepatic Impairment | Talazoparib: Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 7 | 10 | 5 | 16 | 38 | |
| Age, Continuous | years | 60.3 (SD 7.61) | 56.6 (SD 17.08) | 60.4 (SD 6.31) | 52.7 (SD 11.98) | 56.1 (SD 12.40) |
| Sex: Female, Male: Female | Participants | 5 | 7 | 5 | 9 | 26 |
| Sex: Female, Male: Male | Participants | 2 | 3 | 0 | 7 | 12 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 2 | 1 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 7 | 3 | 14 | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 0 | 1 | 4 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 2 | 0 | 1 | 4 |
| Race/Ethnicity, Customized: White | Participants | 5 | 8 | 5 | 13 | 31 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 0 | 0 | 2 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22, measured over Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanogram*hour per milliliter |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the free-plasma talazoparib concentration-time curve from zero to 24 hours after dosing on Day 22, expressed in nanogram*hour per milliliter. In general, an area under a concentration-time curve represents cumulative drug exposure over the interval being measured. It incorporates concentration readings across time rather than relying on a single measurement. The registry definition specifies the interval and identifies the endpoint as free-plasma exposure.
The registry describes the endpoint using a geometric mean and a geometric coefficient of variation. In general, geometric summaries are useful for measurements that are positive and may vary multiplicatively or have a skewed distribution. A geometric mean summarizes the central level on a multiplicative scale; a geometric coefficient of variation describes relative dispersion on that scale. These summaries do not, by themselves, show how precisely groups differ. For that, readers would need group estimates and uncertainty measures, such as confidence intervals.
The endpoint is relevant to a pharmacokinetic question because exposure can be compared descriptively across the hepatic-function categories. The record specifies blood-sampling times around the Day 22 dose, including a pre-dose sample and post-dose samples through 24 hours. The numerical endpoint estimates by group, their uncertainty, and any formal between-group contrasts are not reported in the registry record. Consequently, the endpoint definition alone does not establish the direction or size of any group differences.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s purpose, population categories, intervention, and primary pharmacokinetic outcome. It does not report numerical results for the Day 22 primary endpoint. In particular, group-specific geometric means, geometric coefficients of variation, between-group estimates, and confidence intervals are not reported in the registry record. The size and precision of any exposure differences therefore cannot be assessed from the primary outcome information.
The study compares non-randomized groups defined by hepatic function. The normal hepatic function category is described as a control, but the groups were not formed through random assignment. As a general statistical consideration, non-randomized group comparisons can reflect both the grouping characteristic and other differences between participants. This means that even a reported contrast would need to be interpreted as an observed association unless the analysis and its assumptions justified a stronger interpretation. An adjustment strategy is not reported in the registry record.
The record lists secondary pharmacokinetic outcomes involving total and unbound plasma concentrations, exposure, and trough concentrations at specified visits. Their presence shows the range of measurements planned or registered, but does not communicate their numerical findings. The registry also lists safety information by hepatic-function group. Those counts are described separately under safety; they do not substitute for pharmacokinetic estimates or establish a comparative safety effect.
Several details that would support a fuller statistical interpretation are not reported in the registry record: the numerical primary outcome results, uncertainty intervals, a detailed analysis plan, the handling of missing or unevaluable pharmacokinetic measurements, and any adjustment for multiple outcomes or comparisons. The primary analysis population is described in part, including Day 22 completion and dosing requirements, but its full criterion text is not reported in the registry record.
The study is listed as completed, with enrollment of 38. Those details do not show how many participants contributed to the primary analysis or whether all outcome data were available. Nor does completion provide evidence about the magnitude, precision, or clinical meaning of the pharmacokinetic findings. The registry record supports a description of the study question and design, but its reported information is insufficient to draw conclusions about the primary endpoint’s result.
9. Statistical Methods Explained
What does the primary measure represent?
The primary measure is the free-plasma area under the talazoparib concentration-time curve over the interval from zero to 24 hours on Day 22. In general, the area under a curve combines concentration information across a defined period. A higher value would indicate greater cumulative measured exposure over that interval, while a lower value would indicate less, if values were reported. The registry record does not report the group values, so no direction or magnitude of exposure differences can be described.
The endpoint is based on blood samples collected at specified times. The registry lists a pre-dose sample, samples at 0.5, 1, 2, 4, and 6 hours, a sample anytime from 8 to 12 hours, and a sample at 24 hours post-dose on Day 22. In general, concentration-time sampling is used to characterize how a measured drug concentration changes after dosing and to estimate exposure across the interval. The registry does not report the calculation details used to derive each participant’s area under the curve.
Why use geometric summaries?
The primary outcome is summarized by a geometric mean, with a geometric coefficient of variation as its dispersion measure. In general, positive pharmacokinetic measurements may be right-skewed, and their variation may be more naturally described in relative or multiplicative terms than by additive differences. A geometric mean summarizes the center after taking account of that multiplicative scale. A geometric coefficient of variation characterizes relative spread around the geometric mean. It is not the same as a confidence interval and should not be read as a direct measure of the precision of a group comparison.
A confidence interval, in general, gives a range of values compatible with the data and the statistical method used, while reflecting sampling uncertainty. Its width helps readers judge precision. A confidence interval for a group contrast would be particularly useful for this non-randomized study, but such intervals are not reported in the registry record. The geometric summaries alone, even if available, would not replace a direct estimate and uncertainty interval for the contrast of interest.
What does the design imply for comparisons?
The study is described as parallel and non-randomized, with no masking. In a parallel design, participants belong to a group during the study rather than crossing through each condition in sequence. Here, groups correspond to categories of hepatic function. Because allocation was not randomized, group differences may be entangled with other participant characteristics. This is a general limitation of observational or non-randomized comparisons, not a finding that any particular confounding occurred in this trial. The registry record does not report a detailed covariate-adjustment strategy.
The normal hepatic function group is labelled as a control in the arm description, but that label does not make it a randomized control. The study is not a like-for-like randomized treatment comparison. Interpretations should focus on how the registered groups were defined and what their observed pharmacokinetic measurements might describe, rather than treating the groups as if assignment had balanced participant characteristics.
How should the planning assumptions be read?
The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. For time-to-event calculations, the illustration gives total events using the Schoenfeld method; for other calculations, it gives participants per arm. These are planning assumptions, not evidence that the trial was designed using them or that the trial had a particular probability of detecting an effect.
In general, a planning calculation estimates the number of participants or events needed under specified assumptions. Its result depends on the effect size, variability, significance level, allocation, and statistical method. An illustration based on an observed effect is especially dependent on that effect estimate and should not be called observed power. The registry record does not report the numerical planning estimates in the information summarized for this analysis, and it does not report the trial’s own sample-size justification.
What analyses can be assessed?
The registry lists 32 outcome measures and 20 analyses, but does not provide a complete statistical analysis plan in the record. The primary endpoint is defined, and the summary statistic and dispersion measure are named. Further details, including the method for comparing groups, any transformation of the observations, treatment of values below assay limits, and construction of uncertainty intervals, are not reported in the registry record. General statistical explanations cannot fill those trial-specific gaps.
Over-dispersion, in general, occurs when observed variability is greater than a model assumes. If a model underestimates variability, its uncertainty estimates can be too narrow and inferential results can be misleading. The registry record does not report whether over-dispersion was assessed or whether a model was used for the primary endpoint. This concept is relevant as a general consideration, not as a claim about an analysis performed in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 32 outcome measures and 20 analyses. The outcomes include the primary Day 22 free-plasma exposure measure and secondary pharmacokinetic measures covering exposure, maximum concentration, time to maximum concentration, unbound fractions and concentrations, and trough concentrations. When multiple outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. In general, a prespecified multiplicity strategy can address that issue, for example by controlling an error rate or by identifying a primary analysis that is interpreted separately. The multiplicity strategy for this study is not reported in the registry record.
The registry defines a pharmacokinetic evaluable analysis population that includes participants who completed the Day 22 visit and met stated dosing and adherence conditions, including at least 10 consecutive days of a 0.5 mg daily dose immediately before that visit. The available criterion text is incomplete, so the full eligibility definition is not reported in the registry record. The enrollment figure of 38 does not establish how many participants were included in this analysis population or contributed usable measurements.
Missing-data procedures are not reported in the registry record. It does not state how missing samples, missed visits, protocol deviations, or measurements that could not be evaluated were handled in the primary analysis. It also does not report whether any sensitivity analyses examined the effect of missing measurements. These omissions matter because the analyzed participants may differ from those enrolled, and the consequences depend on why measurements are unavailable and how the analysis treats them.
The record’s stated sample-size calculations are planning illustrations based on specified assumptions. They are not observed power, and they do not establish a sample-size justification for the trial. The trial’s own planning rationale and any interim analyses are not reported in the registry record.
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 |
|---|---|---|---|
| Talazoparib: Normal Hepatic Function | 1 | 7 | 14.3% |
| Talazoparib: Mild Hepatic Impairment | 3 | 10 | 30.0% |
| Talazoparib: Moderate Hepatic Impairment | 2 | 5 | 40.0% |
| Talazoparib: Severe Hepatic Impairment | 13 | 16 | 81.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Talazoparib: Normal Hepatic Function | 0 of 7 |
| Talazoparib: Mild Hepatic Impairment | 0 of 10 |
| Talazoparib: Moderate Hepatic Impairment | 1 of 5 |
| Talazoparib: Severe Hepatic Impairment | 7 of 16 |
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 |
|---|---|
| Talazoparib: Normal Hepatic Function | 6 of 7 |
| Talazoparib: Mild Hepatic Impairment | 7 of 10 |
| Talazoparib: Moderate Hepatic Impairment | 3 of 5 |
| Talazoparib: Severe Hepatic Impairment | 10 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Talazoparib: Normal Hepatic Function | Talazoparib: Mild Hepatic Impairment | Talazoparib: Moderate Hepatic Impairment | Talazoparib: Severe Hepatic Impairment |
|---|---|---|---|---|---|
| Disease progression | General disorders | 0 of 7 | 0 of 10 | 0 of 5 | 4 of 16 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 0 of 7 | 0 of 10 | 1 of 5 | 2 of 16 |
| Hyponatraemia | Metabolism and nutrition disorders | 0 of 7 | 0 of 10 | 0 of 5 | 3 of 16 |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 7 | 0 of 10 | 1 of 5 | 2 of 16 |
| Abdominal pain | Gastrointestinal disorders | 0 of 7 | 1 of 10 | 0 of 5 | 2 of 16 |
| Hyperkalaemia | Metabolism and nutrition disorders | 0 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
| Hepatic encephalopathy | Nervous system disorders | 0 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
| Leukocytosis | Blood and lymphatic system disorders | 0 of 7 | 1 of 10 | 0 of 5 | 1 of 16 |
| Pyrexia | General disorders | 0 of 7 | 1 of 10 | 0 of 5 | 0 of 16 |
| Cholangitis | Hepatobiliary disorders | 0 of 7 | 0 of 10 | 0 of 5 | 1 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Talazoparib: Normal Hepatic Function | Talazoparib: Mild Hepatic Impairment | Talazoparib: Moderate Hepatic Impairment | Talazoparib: Severe Hepatic Impairment |
|---|---|---|---|---|---|
| Fatigue | General disorders | 4 of 7 | 1 of 10 | 0 of 5 | 1 of 16 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 7 | 2 of 10 | 0 of 5 | 3 of 16 |
| Nausea | Gastrointestinal disorders | 2 of 7 | 1 of 10 | 0 of 5 | 1 of 16 |
| Diarrhoea | Gastrointestinal disorders | 2 of 7 | 1 of 10 | 0 of 5 | 1 of 16 |
| Anaemia | Blood and lymphatic system disorders | 0 of 7 | 1 of 10 | 0 of 5 | 2 of 16 |
| Vomiting | Gastrointestinal disorders | 1 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 0 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
| Hyponatraemia | Metabolism and nutrition disorders | 0 of 7 | 0 of 10 | 1 of 5 | 1 of 16 |
| Abdominal pain | Gastrointestinal disorders | 0 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
| Coagulopathy | Blood and lymphatic system disorders | 0 of 7 | 0 of 10 | 0 of 5 | 2 of 16 |
Serious events with the highest arm-level rate: disease progression (25.0%), hyperbilirubinaemia (20.0%), neoplasm progression (20.0%), hyponatraemia (18.8%), malignant pleural effusion (14.3%).
The registry reports serious adverse event counts by hepatic-function group. In the normal hepatic function group, 1 among 7 participants at risk was affected; in the mild hepatic impairment group, 3 among 10 were affected; in the moderate hepatic impairment group, 2 among 5 were affected; and in the severe hepatic impairment group, 13 among 16 were affected. The registry also records other adverse events: 6 among 7, 7 among 10, 3 among 5, and 10 among 16, respectively. These are reported counts, not adjusted comparisons.
Deaths recorded by group were 0, 0, 1, and 7, respectively, in the same group order. The record also lists serious-event terms and percentages, including Disease progression at 25.0%, Hyperbilirubinaemia at 20.0%, Neoplasm progression at 20.0%, Hyponatraemia at 18.8%, Malignant pleural effusion at 14.3%, and Hyperkalaemia at 12.5%. These terms and percentages should be read as registry safety entries, not as evidence that talazoparib caused each event. The information does not provide adjusted estimates or a randomized safety comparison.
As a general statistical point, counts from small groups can be unstable, and differences in group size or underlying illness can affect interpretation. The study concerns patients with advanced solid tumors, and the registry record does not provide enough detail to attribute events to treatment, disease, hepatic impairment, or other causes. The safety figures describe what was recorded; they do not establish comparative risk or treatment effect.
12. What the Result Does, and Does Not, Mean
This study addresses a specific pharmacokinetic and safety question: how talazoparib measurements are described among patients with advanced solid tumors across categories of hepatic function. Its registered primary outcome is Day 22 free-plasma exposure, summarized by a geometric mean and geometric coefficient of variation. The registry also identifies a broad set of secondary pharmacokinetic outcomes and reports adverse event counts by group.
The record does not report the numerical primary endpoint results. It therefore cannot establish how exposure differed across the groups, how large any differences were, or how precise those estimates were. Numerical group estimates, uncertainty intervals, and reported between-group comparisons are not reported in the registry record. The study’s completion status and enrollment figure do not fill that gap.
The non-randomized grouping also limits causal interpretation. Hepatic-function categories were not assigned randomly, and the normal-function group, although called a control, is not a randomized comparator. In general, observed group differences in such a design may reflect factors other than the group-defining characteristic. The registry record does not report an adjustment strategy that would address this concern.
The safety entries are descriptive counts and event terms. They do not, on their own, show that talazoparib caused an event or that an event rate differs because of hepatic function. The record does not provide a randomized safety comparison or sufficient detail to separate treatment-related events from effects of advanced disease and other factors.
These limitations do not make the registered question unimportant. They define what can be concluded from the information reported: the design and outcomes can be described, but the primary pharmacokinetic result and its precision cannot be assessed. The record does not establish efficacy, comparative benefit, or a treatment recommendation. Those conclusions would require evidence and analyses beyond the information in the registry record.
13. Why This Trial Matters Statistically
Pharmacokinetic studies examine how drug concentrations vary over time and how measured exposure differs across clinically relevant groups. Hepatic function is the organizing characteristic in this study, which includes normal function and mild, moderate, and severe impairment categories. The Day 22 free-plasma area under the concentration-time curve provides a defined exposure measure over a stated interval. This focus makes the registered question distinct from a trial designed primarily to estimate treatment efficacy.
The study also illustrates why statistical design and interpretation matter in early-phase research. Its parallel, open-label, non-randomized structure can describe measurements within the registered groups, but does not provide the balancing associated with random allocation. The normal-function group is designated as a control, yet its role should not be mistaken for a randomized control group. Clear reporting of group estimates, uncertainty, analysis populations, and adjustment methods would be important for judging the strength of any comparison.
The registry’s geometric summary is also relevant to the interpretation of pharmacokinetic measurements. Such summaries can be suitable for positive measures that vary on a multiplicative scale, while the geometric coefficient of variation describes relative spread. Readers still need uncertainty estimates for the group comparisons to understand precision. Those primary endpoint results are not reported in the registry record.
Finally, the record shows how a study can list numerous pharmacokinetic outcomes and safety measures while leaving important analytic details unavailable. Multiplicity procedures, missing-data handling, and the full statistical plan are not reported in the registry record. Recognizing these gaps prevents descriptive information from being mistaken for a complete inferential result. The trial’s statistical importance lies in the question and design it documents, as well as in the limits that the reported results place on interpretation.
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 most consequential limitation for interpretation is that numerical results for the primary Day 22 exposure endpoint are not reported in the registry record. Without group estimates and uncertainty measures, the amount and precision of any exposure difference cannot be evaluated. The record defines the endpoint and summary statistics but does not report the corresponding values or formal contrasts.
The study was non-randomized and open-label. Participants were grouped by hepatic function, and the normal-function group was described as a control, but it was not a randomized comparator. Group differences may therefore reflect characteristics other than hepatic function. A detailed adjustment strategy is not reported in the registry record.
The primary pharmacokinetic population was restricted by Day 22 completion and dosing and adherence criteria. The full criterion description is not reported in the registry record, and the number of participants who met the criteria is not stated in the information summarized for this analysis. The enrollment figure should not be treated as the number analyzed. Missing-data handling, assay-related exclusions, and sensitivity analyses are also not reported in the registry record.
Although 32 outcome measures and 20 analyses are listed, the record does not describe a multiplicity strategy or a complete statistical analysis plan. The trial’s sample-size justification and any interim analyses are not reported in the registry record. The listed sample-size assumptions describe a planning illustration, not the trial’s design rationale or observed power.
Safety counts are descriptive and arise from groups of different sizes. They do not provide adjusted causal comparisons, and the event listings do not establish attribution to talazoparib. These limitations constrain conclusions about both pharmacokinetics and safety from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) — NCT02997176.
- Registry record last updated 2021-02-25; status last verified 2021-02.
- Results first posted 2021-02-25.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02997176 is a completed Phase I, open-label, non-randomized, parallel study sponsored by Pfizer. It enrolled 38 patients with advanced solid tumors and examined talazoparib pharmacokinetics and safety across normal hepatic function and mild, moderate, or severe hepatic impairment categories. The recorded study dates are 2016-09-30 for start and 2020-02-12 for primary completion.
The primary endpoint is Day 22 free-plasma talazoparib area under the concentration-time curve from zero to 24 hours, summarized by a geometric mean and geometric coefficient of variation. The registry record also lists secondary pharmacokinetic outcomes and safety counts. Numerical primary endpoint results, uncertainty estimates, a detailed statistical analysis plan, multiplicity procedures, and missing-data methods are not reported in the registry record. Because allocation was non-randomized, the hepatic-function groups do not constitute a randomized comparison.