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 Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels (NCT04537715), a non-randomized phase 1 study. The primary outcome is Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours of Quantifiable Concentration (AUC0-12h) of Tazemetostat.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04537715 |
| Phase | Phase 1 |
| Condition | All Malignancies, Advanced Malignancies, Hematologic Malignancy |
| Allocation | Non-Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 42 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Epizyme, Inc. |
| Results posted | Yes |
2. Clinical Question
The study asked how tazemetostat blood exposure was characterized when it was administered in the setting of either itraconazole or rifampin. Part 1 concerned itraconazole, described as a strong CYP3A4 inhibitor in the official title; Part 2 concerned rifampin, described there as a strong CYP3A4 inducer. The registry identifies pharmacokinetics as the main focus, with safety and tolerability assessed throughout both parts.
Population
Participants had advanced malignancies. The registry lists a range of hematologic malignancies and solid tumors, including follicular lymphoma, diffuse large B-cell lymphoma, epithelioid sarcoma, and other conditions. The pharmacokinetic population was defined more narrowly as participants with sufficient concentration data and without a major protocol deviation judged to greatly alter steady-state exposure.
Intervention
Tazemetostat was studied in two interaction parts. In Part 1, the accompanying drug was itraconazole; in Part 2, it was rifampin. The registry describes planned tazemetostat dosing in the arm descriptions, but those descriptions are incomplete, so the full schedules for the accompanying drugs are not reported in the registry record.
Comparator
The registry classifies the study as nonrandomized and crossover. The primary endpoint refers to measurements on Cycle 1 Day 1 and Cycle 1 Day 15, but the record does not give complete details of the exposure sequence or a separate randomized control group. The two parts should not be treated as like-for-like randomized arms.
Primary question
The primary endpoint was the area under the tazemetostat plasma concentration-time curve from time 0 to 12 hours in Part 1. It describes drug exposure over the specified sampling interval. The registry record does not report numerical primary endpoint results, so the size or direction of any pharmacokinetic change cannot be stated from this record.
3. Trial Design
This was a Phase I, open-label, nonrandomized study with a crossover model, and the registry lists enrollment of 42. It was divided into two drug-interaction parts: Part 1 studied tazemetostat with itraconazole, while Part 2 studied tazemetostat with rifampin. The official title describes the accompanying drugs as a strong CYP3A4 inhibitor and a strong CYP3A4 inducer, respectively. The registry classifies masking as none.
The study population consisted of people with advanced malignancies. The listed conditions span hematologic malignancies and solid tumors. The brief summary says the main aim was to study tazemetostat pharmacokinetics when administered in combination with another drug, with safety and tolerability assessed throughout both parts. This is a pharmacokinetic interaction study, not a randomized comparison of treatments for cancer outcomes.
The primary outcome is specific to Part 1 and measures tazemetostat AUC from time 0 to 12 hours. Samples were scheduled from predose through 12 hours after dosing on Cycle 1 Day 1 and Cycle 1 Day 15. The registry also lists secondary pharmacokinetic outcomes involving tazemetostat and EPZ-6930, including AUC, maximum concentration, time to maximum concentration, and apparent terminal elimination half-life. Numerical results for these outcomes are not reported in the registry record.
The arm descriptions include some tazemetostat dose and schedule details, but the descriptions end before the full regimens are stated. The complete schedule for itraconazole and rifampin, the order and timing of all treatment periods, and the rationale for the enrollment target are not reported in the registry record. The record lists study status as completed, but completion status does not itself supply outcome estimates.
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: This study consisted of a screening period (up to 30 days), Part 1 consisted of Cycle 1 till Day 39, Cycle 2 started on Day 40 and each subsequent cycle was of 28-day duration; Part 2 also consisted of Cycle 1 till Day 26, Cycle 2 started on Day 27 of and each subsequent cycle was of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
Overall Study
| Stage | Part 1: Tazemetostat + Itraconazole | Part 2: Tazemetostat + Rifampin |
|---|---|---|
| STARTED | 21 | 21 |
| COMPLETED | 10 | 16 |
| NOT COMPLETED | 11 | 5 |
Reasons for not completing this period:
| Reason | Part 1: Tazemetostat + Itraconazole | Part 2: Tazemetostat + Rifampin |
|---|---|---|
| Death | 3 | 1 |
| Withdrawal by Subject | 3 | 1 |
| Other | 4 | 3 |
| Progressive disease | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Pharmacokinetic (PK) population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Enrolled population included all participants who signed informed consent and met all screening criteria.
| Characteristic | Unit | Part 1: Tazemetostat + Itraconazole | Part 2: Tazemetostat + Rifampin | Total |
|---|---|---|---|---|
| Participants analysed | 21 | 21 | 42 | |
| Age, Continuous | years | 60.9 (SD 13.45) | 60.1 (SD 13.05) | 60.5 (SD 13.09) |
| Sex: Female, Male: Female | Participants | 8 | 13 | 21 |
| Sex: Female, Male: Male | Participants | 13 | 8 | 21 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 19 | 18 | 37 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: White | Participants | 18 | 12 | 30 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: Black or African American | Participants | 0 | 2 | 2 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Not reported/Other | Participants | 1 | 4 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours of Quantifiable Concentration (AUC0-12h) of Tazemetostat, measured over Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | hours*nanogram/milliliter (h*ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is Part 1 AUC from time 0 to 12 hours for tazemetostat, expressed in hours*nanogram/milliliter (h*ng/mL). AUC represents exposure accumulated across a concentration-time interval: it takes account of both the concentrations measured and how they change over time. It is therefore a pharmacokinetic measure rather than a direct measure of tumor response, symptom change, or survival.
Blood samples were scheduled at predose (0 hour) and 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15. The registry says AUC was estimated by non-compartmental analysis using the linear trapezoidal method for concentrations going up and the logarithmic trapezoidal method for concentrations going down. In general, this approach estimates the area between sampled time points from the observed concentration profile; it does not require describing the full profile with a specified compartment model.
The endpoint is reported as a geometric mean, with geometric coefficient of variation as its dispersion measure. In general, geometric summaries are used for positive pharmacokinetic measures that may be right-skewed, while the coefficient of variation describes relative variability on a multiplicative scale. The numerical geometric means and dispersion estimates are not reported in the registry record, so the endpoint's observed magnitude and precision cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the study objective, the primary pharmacokinetic endpoint, its measurement schedule, and adverse-event counts. It does not report numerical primary endpoint results or analysis estimates. As a result, the record does not establish the amount or direction of any difference in tazemetostat exposure between measurement occasions, nor does it provide an estimate of how precisely such a difference was measured.
The primary endpoint is an exposure measure, not a clinical efficacy endpoint. AUC from time 0 to 12 hours summarizes plasma concentration over that sampling interval. In general, a comparison of this measure can help characterize a drug interaction, but interpretation depends on the actual estimates, their variability, the participant population, and the analysis method. Those numerical estimates are not reported in the registry record. The posted endpoint definition alone cannot show whether exposure increased, decreased, or remained similar.
The study has two distinct interaction parts. Part 1 concerns itraconazole and Part 2 concerns rifampin. Although the registry classifies the overall study as nonrandomized and crossover, it also states that the arms are not a like-for-like control comparison. The two parts should therefore not be interpreted as randomized groups directly compared with each other. The record does not provide enough detail to reconstruct the full sequence of treatment periods or identify the exact contrast used for every pharmacokinetic analysis.
The enrollment entry is 42, and each adverse-event group lists 21 participants at risk. These figures describe the registry enrollment and safety group denominators; they do not establish the size of the pharmacokinetic analysis population. That population was defined by availability of sufficient pharmacokinetic concentration data and absence of a major protocol deviation judged to greatly alter steady-state exposure. Its analyzed size is not reported in the registry record.
Safety counts can be read as descriptive observations in the two groups, but they do not by themselves identify whether an event was caused by a study drug. The registry does not report the attribution details, event timing, or full clinical context needed to interpret the counts as causal evidence. The deaths listed in the group summaries are also not accompanied by causes or attribution in the registry record. Neither these safety data nor the pharmacokinetic endpoint should be used to infer an effect on malignancy outcomes.
9. Statistical Methods Explained
The registry describes the primary endpoint as a geometric mean AUC from time 0 to 12 hours, with geometric coefficient of variation as the dispersion measure. It says the AUC was estimated by non-compartmental analysis using a linear-up/log-down trapezoidal approach. The record also defines a pharmacokinetic population based on adequate concentration data and protocol-deviation criteria. It does not report the numerical primary analysis, its confidence interval, a test statistic, or a p-value.
What does AUC measure?
In general, area under the concentration-time curve summarizes the overall plasma exposure over a specified time interval. Concentrations are observed at scheduled sample times, and an area is estimated between adjacent observations. AUC differs from a single concentration measurement: it reflects the trajectory across the interval, rather than exposure at one selected time. The endpoint is limited to the interval from time 0 to 12 hours, so it should not be described as total exposure over all time.
The registry lists sampling at predose (0 hour), then 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15. In general, denser sampling around changes in concentration can help characterize the curve, while the estimate still depends on the observed samples and the method used between them. The record does not report concentration values, participant-level profiles, or numerical AUC estimates.
Why use a linear-up/log-down estimate?
In general, the trapezoidal method approximates the area between adjacent observations. A linear rule treats the segment as changing at a constant rate. A logarithmic rule can better represent a declining concentration segment when the decline is approximately exponential. The registry states that the linear rule was used for concentrations going up and the logarithmic rule for concentrations going down. This describes how the endpoint was calculated; it does not reveal the resulting exposure.
What do geometric summaries convey?
In general, pharmacokinetic measures are positive and may have a skewed distribution. A geometric mean summarizes values on a multiplicative scale and can be more representative than an arithmetic mean when values vary proportionally. The geometric coefficient of variation describes relative spread, rather than spread in the original measurement units. These summaries are not substitutes for the individual observations, and their interpretation depends on the underlying estimates and analysis population. Neither the geometric mean nor the geometric coefficient of variation for the primary endpoint is reported in the registry record.
What does the study classification imply?
The registry labels the study open-label, nonrandomized, and crossover. In general, open-label means treatment assignment is not masked from participants or investigators; nonrandomized means assignment is not determined by random allocation. A crossover model generally involves observations across more than one treatment condition, but the full sequence and period details are not reported in the registry record. The classification alone is not enough to reconstruct which measurements were compared or how possible period effects were handled.
The record explicitly cautions that the arms are not a like-for-like control comparison. Part 1 evaluates itraconazole and Part 2 evaluates rifampin, so differences between their group summaries would not constitute a randomized comparison of the two accompanying drugs. The record does not report a statistical model or adjustment strategy for the pharmacokinetic comparisons.
How should precision be assessed?
In general, a confidence interval describes a range of values compatible with the observed data under the analysis assumptions. Its width indicates precision: narrower intervals indicate less uncertainty in the estimated quantity, while wider intervals indicate more. A p-value addresses compatibility with a specified null hypothesis under assumptions; it does not describe the size or clinical importance of an effect. No confidence interval, p-value, or numerical effect estimate for the primary endpoint is reported in the registry record, so precision and statistical evidence cannot be evaluated from that endpoint entry.
In general, over-dispersion means the variability in data is greater than a model assumes. When present, a model that understates variability can give misleadingly narrow uncertainty estimates. The registry record does not report whether over-dispersion was assessed or whether it was relevant to any analysis. More broadly, details such as the pharmacokinetic comparison model, transformations, handling of values below quantification limits, and sensitivity analyses are not reported in the registry record. These methodological details should not be inferred from the endpoint definition alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 30 outcome measures, including a primary Part 1 AUC endpoint and secondary pharmacokinetic measures for tazemetostat and EPZ-6930. It also lists outcomes in both study parts, such as AUC, maximum concentration, time to maximum concentration, and apparent terminal elimination half-life. The record does not report a multiplicity strategy, such as a hierarchy of confirmatory tests, an adjustment across outcomes, or identification of which outcomes were intended to support confirmatory claims. Without those details and numerical results, the strength of evidence across the collection of outcomes cannot be assessed.
The registry record does not report a statistical analysis plan, interim analyses, or a sample-size justification. It also does not report how missing concentrations, incomplete sampling profiles, values below quantification limits, or other unavailable observations were handled. These omissions matter because AUC estimates rely on concentration measurements across the stated interval, and the pharmacokinetic population excludes participants lacking sufficient concentration data to calculate steady-state parameters.
The defined pharmacokinetic population included participants with sufficient PK concentration data in Part 1 and no major protocol deviation judged to greatly alter steady-state exposure to tazemetostat or itraconazole. The size of that population and any corresponding population definition for Part 2 are not reported in the registry record. The registry enrollment entry and safety denominators should not be substituted for analyzed endpoint counts.
In general, missing-data procedures and analysis-population definitions help explain which observations contribute to an estimate and what assumptions are used when observations are incomplete. Here, the population definition is stated, but the numerical analysis population, missingness pattern, and handling methods are not reported in the registry record. Therefore, the potential influence of exclusions or incomplete concentration profiles cannot be quantified.
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: Tazemetostat + Itraconazole | 8 | 21 | 38.1% |
| Part 2: Tazemetostat + Rifampin | 9 | 21 | 42.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: Tazemetostat + Itraconazole | 10 of 21 |
| Part 2: Tazemetostat + Rifampin | 3 of 21 |
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 |
|---|---|
| Part 1: Tazemetostat + Itraconazole | 19 of 21 |
| Part 2: Tazemetostat + Rifampin | 20 of 21 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1: Tazemetostat + Itraconazole | Part 2: Tazemetostat + Rifampin |
|---|---|---|---|
| Pericardial effusion | Cardiac disorders | 2 of 21 | 0 of 21 |
| Pneumonia | Infections and infestations | 1 of 21 | 1 of 21 |
| Sepsis | Infections and infestations | 0 of 21 | 2 of 21 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 21 | 0 of 21 |
| Colitis | Gastrointestinal disorders | 1 of 21 | 0 of 21 |
| Diarrhoea | Gastrointestinal disorders | 0 of 21 | 1 of 21 |
| Vomiting | Gastrointestinal disorders | 0 of 21 | 1 of 21 |
| Oedema peripheral | General disorders | 0 of 21 | 1 of 21 |
| Pain | General disorders | 0 of 21 | 1 of 21 |
| Abdominal infection | Infections and infestations | 1 of 21 | 0 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: Tazemetostat + Itraconazole | Part 2: Tazemetostat + Rifampin |
|---|---|---|---|
| Fatigue | General disorders | 6 of 21 | 9 of 21 |
| Anaemia | Blood and lymphatic system disorders | 6 of 21 | 5 of 21 |
| Nausea | Gastrointestinal disorders | 6 of 21 | 5 of 21 |
| Decreased appetite | Metabolism and nutrition disorders | 7 of 21 | 4 of 21 |
| Constipation | Gastrointestinal disorders | 5 of 21 | 5 of 21 |
| Diarrhoea | Gastrointestinal disorders | 2 of 21 | 7 of 21 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 21 | 2 of 21 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 21 | 6 of 21 |
| Lymphocyte count decreased | Investigations | 2 of 21 | 4 of 21 |
| Back pain | Musculoskeletal and connective tissue disorders | 3 of 21 | 3 of 21 |
Serious events with the highest arm-level rate: pericardial effusion (9.5%), sepsis (9.5%), acute respiratory failure (9.5%), colitis (4.8%), diarrhoea (4.8%).
The registry reports serious adverse events for 8 of 21 participants in the tazemetostat plus itraconazole group and 9 of 21 in the tazemetostat plus rifampin group. Other adverse events were reported for 19 of 21 and 20 of 21 participants, respectively. The group summaries also list 10 deaths in the first group and 3 in the second. These are descriptive counts within the listed groups; the record does not establish that the groups are comparable or that the differences reflect a drug effect.
The listed serious-event terms and percentages are pericardial effusion (9.5%), sepsis (9.5%), acute respiratory failure (9.5%), colitis (4.8%), diarrhoea (4.8%), and vomiting (4.8%). The registry record does not specify which group each listed term belongs to, give the corresponding event counts, or report whether the events were considered related to treatment. It also does not provide causes or attribution for the deaths.
In general, a participant count with at least one event is different from a count of all event episodes; one participant may experience more than one event. The registry summary does not provide enough detail to determine episode counts or overlap among event categories. These figures describe reported safety observations and should not be interpreted as a causal comparison or as a measure of cancer-treatment benefit.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study focused on tazemetostat pharmacokinetics in advanced malignancies and evaluated two drug-interaction parts: itraconazole in Part 1 and rifampin in Part 2. It defines a primary Part 1 endpoint, AUC from time 0 to 12 hours, and describes its sampling schedule and calculation method. It also records safety counts for the two groups.
What the record does not establish is the numerical pharmacokinetic result. Without the primary endpoint estimates, their variability, and an analysis of the relevant comparison, it is not possible to say from this record whether tazemetostat exposure changed, by how much it changed, or how precisely that change was estimated. The endpoint definition and study objective are not substitutes for outcome estimates.
The record also does not establish a direct randomized comparison between itraconazole and rifampin. The study is classified as nonrandomized, and the registry cautions that its arms are not a like-for-like control comparison. Accordingly, the safety summaries should be read as descriptive counts, not as evidence that one combination has a higher or lower risk than the other.
In general, pharmacokinetic findings describe drug concentrations and exposure, while clinical efficacy outcomes describe how participants fare in relation to their disease. The primary endpoint is pharmacokinetic, and the registry does not report a primary cancer-response outcome. It would therefore be inappropriate to infer from this record whether tazemetostat improves or worsens malignancy outcomes, or to draw conclusions about an individual’s care.
The record indicates a completed Phase I study with enrollment of 42, but completion and enrollment alone do not establish what the outcome estimates were. Full interpretation would require numerical results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because it focuses on pharmacokinetic interaction rather than a randomized comparison of clinical treatment outcomes. Its primary endpoint, AUC from time 0 to 12 hours, captures exposure across a defined sampling interval. The registry also identifies a non-compartmental estimation method and a pharmacokinetic population definition, which are important pieces of context when interpreting an exposure estimate.
The study has separate parts for itraconazole and rifampin, described in the official title as a strong CYP3A4 inhibitor and a strong CYP3A4 inducer. These are distinct interaction questions. Because the registry classifies the study as nonrandomized and says the arms are not a like-for-like control comparison, statistical interpretation should keep the parts distinct rather than treating them as randomized alternatives.
The record illustrates why endpoint definitions and numerical results answer different questions. A carefully specified endpoint tells readers what was intended to be measured and how; without estimates and measures of uncertainty, it does not tell readers the observed magnitude or precision. Here, the registry describes the AUC procedure but does not report the numerical primary endpoint result.
It also highlights the importance of transparent analysis details. The registry defines the Part 1 pharmacokinetic population, but does not report its size, missing-data methods, multiplicity approach, or statistical model. Such information helps readers understand which observations contributed to the estimates and how uncertainty was handled. The safety counts add descriptive context, but without event attribution and adequate comparative design they cannot be read as causal contrasts.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for statistical interpretation is that numerical results for the primary pharmacokinetic endpoint are not reported in the registry record. No primary estimate, variability value, confidence interval, test statistic, or p-value is available there. Consequently, the amount and precision of any exposure change cannot be evaluated.
The registry identifies the study as nonrandomized and explicitly cautions that the arms are not a like-for-like control comparison. The two parts concern different accompanying drugs, so their group summaries should not be treated as a direct randomized contrast. Although a crossover model is listed, the full sequence of treatment periods and the analysis of any period or sequence effects are not reported in the registry record.
The arm descriptions give only partial dosing schedules. Complete regimens for the accompanying drugs and full schedule details are not reported in the registry record. The record also does not state the rationale for the enrollment target, the statistical analysis plan, interim-analysis procedures, or a multiplicity strategy.
The pharmacokinetic population is defined, but its size is not reported. The record does not describe missing concentration handling, values below quantification limits, sensitivity analyses, or the statistical model used for comparisons. These gaps limit assessment of how representative the analyzed data were and how robust the estimates might be.
Safety information is also limited to summary counts and a list of serious-event terms with percentages. Event-level counts by group, attribution, timing, causes of death, and overlap among event categories are not reported in the registry record. These limits make the safety summaries descriptive rather than causal.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels — NCT04537715.
- Registry record last updated 2025-02-19; status last verified 2025-02.
- Results first posted 2024-08-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04537715 is a completed Phase I, open-label, nonrandomized crossover study with registry enrollment of 42. It examined tazemetostat pharmacokinetics in advanced malignancies in two parts: one involving itraconazole and one involving rifampin. The primary endpoint was Part 1 tazemetostat AUC from time 0 to 12 hours, estimated using non-compartmental analysis.
The registry describes secondary pharmacokinetic outcomes and reports adverse-event group summaries. It lists 21 participants at risk in each safety group, along with serious adverse events, other adverse events, and deaths. It cautions that the arms are not a like-for-like control comparison.
Numerical primary pharmacokinetic results, analysis estimates, and key statistical details such as missing-data handling and multiplicity procedures are not reported in the registry record. The endpoint definition and safety counts therefore do not establish the size or precision of a pharmacokinetic effect or a causal safety difference.