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 Decitabine and Talazoparib in Untreated AML and R/R AML (NCT02878785), a randomized phase 1, phase 2 study. The primary outcome is Phase 1 - Dose Finding.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02878785 |
| Phase | Phase 1, Phase 2 |
| Condition | Acute Myeloid Leukemia |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | 14 |
| Lead sponsor | University of Maryland, Baltimore |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes adults with acute myeloid leukemia, including people with relapsed or refractory disease and adults considered unlikely to tolerate or respond to standard chemotherapy. The primary dose-finding outcome identifies its population as 25 patients with relapsed or refractory acute myeloid leukemia.
Intervention
The study evaluated decitabine combined with talazoparib. The brief description says all participants would receive the combination. In Phase 1, decitabine was described as intravenous treatment daily for 5 days every 28 days, with talazoparib taken orally daily on days 1–28.
Comparator
No separate treatment comparator is described for the posted dose-finding outcome. The brief description says all participants would receive both drugs. The registry record classifies allocation as randomized and the model as factorial, but the details of any random allocation or factorial comparison are not reported in the registry record.
Primary question
The primary dose-finding question was which recommended Phase 2 doses of decitabine to select, based on numbers of participants with treatment-related adverse events. These events were to be evaluated using Version 4.0 of the NCI Common Terminology Criteria for Adverse Events. The outcome timeframe is described as a cycle length of 28 days.
3. Trial Design
This was a Phase 1/2 study of decitabine and talazoparib for acute myeloid leukemia. It is marked completed, with enrollment of 25. The registry describes the study as randomized, unmasked, and factorial. However, the posted primary outcome is a Phase 1 dose-finding outcome organized by cohort, and the registry does not report the operational details needed to understand how randomization or the factorial model applied to the posted results.
The Phase 1 description characterizes the approach as nested dose escalation. Its stated purpose was to identify dose levels for use in the combination. The registry lists cohort-level values of 10.0, 15.0, and 20.0 mg/m² among the reported cohorts. Cohorts 1 through 7 have participant counts; cohorts 8 through 14 have zero participants and no reported dose value. These are dose-finding observations, not results from a posted two-arm efficacy comparison.
The Phase 2 description includes three populations: adults considered unlikely to tolerate or respond to standard chemotherapy, adults whose AML did not respond to previous treatment or returned after responding, and adults previously treated with a DNA methyltransferase inhibitor. The brief summary describes Phase 2 as having three arms, but comparative Phase 2 outcomes are not posted among the results described by the registry record.
Masking is listed as none. The protocol details governing dose assignment, cohort progression, and any allocation across Phase 2 arms are not reported in the registry record. The posted results therefore support a description of the dose-finding cohorts and recorded safety information, but not a reconstruction of the full trial conduct or a comparison of treatment effects.
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.
Only the first 6 of 14 groups are shown.
Overall Study
| Stage | Cohort 1: Decitabine and Talazoparib Combo: Decitabine :10 mg/m^2: Period 1: | Cohort 8: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2: Period 1a: | Cohort 9: Decitabine and Talazoparib Combo:Decitabine : 15 mg/m^2;Period 2: | Cohort 10: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2;Period 1b: | Cohort 11: Decitabine and Talazoparib Combo:Decitabine : 10 mg/m^2;Period 1c: | Cohort 12: Decitabine and Talazoparib Combo:Decitabine :15 mg/m^2;Period 2a |
|---|---|---|---|---|---|---|
| STARTED | 3 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 3 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 25 patients with relapsed or refractory acute myeloid leukemia
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: We completed the phase 1 study, but did not proceed to phase 2.
| Characteristic | Unit | Phase 1: Decitabine and Talazoparib Combo |
|---|---|---|
| Participants analysed | 25 | |
| Age, Categorical: Cohort 1 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 1 – Between 18 and 65 years | Participants | 1 |
| Age, Categorical: Cohort 1 – >=65 years | Participants | 2 |
| Age, Categorical: Cohort 2 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 2 – Between 18 and 65 years | Participants | 0 |
| Age, Categorical: Cohort 2 – >=65 years | Participants | 3 |
| Age, Categorical: Cohort 3 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 3 – Between 18 and 65 years | Participants | 1 |
| Age, Categorical: Cohort 3 – >=65 years | Participants | 2 |
| Age, Categorical: Cohort 4 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 4 – Between 18 and 65 years | Participants | 2 |
| Age, Categorical: Cohort 4 – >=65 years | Participants | 5 |
| Age, Categorical: Cohort 5 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 5 – Between 18 and 65 years | Participants | 2 |
| Age, Categorical: Cohort 5 – >=65 years | Participants | 1 |
| Age, Categorical: Cohort 6 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 6 – Between 18 and 65 years | Participants | 2 |
| Age, Categorical: Cohort 6 – >=65 years | Participants | 1 |
| Age, Categorical: Cohort 7 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 7 – Between 18 and 65 years | Participants | 2 |
| Age, Categorical: Cohort 7 – >=65 years | Participants | 1 |
| Age, Categorical: Cohort 8 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 8 – Between 18 and 65 years | Participants | 0 |
| Age, Categorical: Cohort 8 – >=65 years | Participants | 0 |
| Age, Categorical: Cohort 9 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 9 – Between 18 and 65 years | Participants | 0 |
| Age, Categorical: Cohort 9 – >=65 years | Participants | 0 |
| Age, Categorical: Cohort 10 – <=18 years | Participants | 0 |
| Age, Categorical: Cohort 10 – Between 18 and 65 years | Participants | 0 |
| Age, Categorical: Cohort 10 – >=65 years | Participants | 0 |
| Age, Continuous: Cohort 1 | years | 75 (64 to 78) |
| Age, Continuous: Cohort 2 | years | 75 (69 to 89) |
| Age, Continuous: Cohort 3 | years | 69 (37 to 70) |
| Age, Continuous: Cohort 4 | years | 73 (45 to 87) |
| Age, Continuous: Cohort 5 | years | 63 (63 to 74) |
| Age, Continuous: Cohort 6 | years | 57 (55 to 73) |
| Age, Continuous: Cohort 7 | years | 55 (53 to 71) |
| Age, Continuous: Cohort 8 | years | — |
| Age, Continuous: Cohort 9 | years | — |
| Age, Continuous: Cohort 10 | years | — |
| Sex: Female, Male: Cohort 1 – Female | Participants | 2 |
| Sex: Female, Male: Cohort 1 – Male | Participants | 1 |
| Sex: Female, Male: Cohort 2 – Female | Participants | 1 |
| Sex: Female, Male: Cohort 2 – Male | Participants | 2 |
| Sex: Female, Male: Cohort 3 – Female | Participants | 1 |
| Sex: Female, Male: Cohort 3 – Male | Participants | 2 |
| Sex: Female, Male: Cohort 4 – Female | Participants | 2 |
| Sex: Female, Male: Cohort 4 – Male | Participants | 5 |
| Sex: Female, Male: Cohort 5 – Female | Participants | 2 |
| Sex: Female, Male: Cohort 5 – Male | Participants | 1 |
| Sex: Female, Male: Cohort 6 – Female | Participants | 1 |
| Sex: Female, Male: Cohort 6 – Male | Participants | 2 |
| Sex: Female, Male: Cohort 7 – Female | Participants | 1 |
| Sex: Female, Male: Cohort 7 – Male | Participants | 2 |
| Sex: Female, Male: Cohort 8 – Female | Participants | — |
| Sex: Female, Male: Cohort 8 – Male | Participants | — |
| Sex: Female, Male: Cohort 9 – Female | Participants | — |
| Sex: Female, Male: Cohort 9 – Male | Participants | — |
| Sex: Female, Male: Cohort 10 – Female | Participants | — |
| Sex: Female, Male: Cohort 10 – Male | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Phase 1 - Dose Finding, measured over Cycle length = 28 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m^2 |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is labeled Phase 1 dose finding. It was intended to determine recommended Phase 2 doses of decitabine using the numbers of participants with treatment-related adverse events. The registry says those events were evaluated according to Version 4.0 of the NCI Common Terminology Criteria for Adverse Events. The stated timeframe is a cycle length of 28 days.
Dose-finding outcomes serve a different purpose from outcomes that estimate whether a treatment improves a clinical condition. In general, dose escalation uses observed tolerability to inform which dose or doses should be taken forward for further study. The registry’s posted values are cohort-level dose values, accompanied by cohort participant counts. They do not provide a comparative estimate of clinical benefit, nor do they give a participant-level account of the adverse events used to select a dose.
The results record does not provide a dose-selection rule, a numerical definition of the recommended Phase 2 dose, or cohort-specific treatment-related adverse-event counts. Those details are not reported in the registry record. As a result, the posted outcome can be read as a record of dose levels studied and cohort sizes, but it does not by itself show how the recommended dose decision was reached.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are descriptive dose-finding data. Cohort 1 has 3 participants and a reported value of 10.0 mg/m²; Cohort 2 has 3 participants and a value of 15.0 mg/m². Cohorts 3 through 7 have reported values of 20.0 mg/m², with participant counts of 3, 7, 3, 3, and 3, respectively. Cohorts 8 through 14 list zero participants and no value. The registry does not explain why the cohort sizes or repeated values differ, so those patterns should not be assigned a cause.
These entries are not estimates of a treatment effect. The registry does not post a two-arm comparison, a confidence interval, a p-value, or an analysis of the effect of the drug combination. No analyses are listed. A result of 20.0 mg/m² in several cohorts should not be read as evidence that this dose was safer or more effective than another dose: the outcome entries do not include the event counts required to make that assessment, and the registry does not identify a final recommended dose in the posted results.
The safety record reports that 25 participants were at risk for serious adverse events and 25 were affected. It also reports that 25 participants were at risk for other adverse events and 25 were affected. Two deaths are recorded. The registry does not give causes of death in these results, nor does it provide the timing, event counts, severity breakdown, or a treatment attribution for the deaths. The listed serious-event terms include fever, infection, sepsis/bacteremia, respiratory events, other infections, and hyperbilirubinemia, each with its recorded percentage. These percentages should be interpreted in the context of the registry’s event reporting, not as a comparison between treatments.
Because the posted endpoint and results are centered on dose finding, they do not answer whether the combination is more effective than decitabine alone or any other treatment. The brief summary describes the investigators’ rationale and aims, but aims are not results. There are no posted secondary outcomes or comparative analyses with which to estimate efficacy or quantify uncertainty about a treatment difference.
In general, a small cohort-level dose-finding record can indicate which doses were studied and how many participants were assigned to each recorded cohort. It is less informative when event counts, decision rules, and dose-selection details are unavailable. This limits both the precision of conclusions about tolerability and the ability to assess how the chosen dose relates to the observed safety data. The registry record does not report a final inferential analysis that resolves those limitations.
9. Statistical Methods Explained
In general, a dose-finding study uses accumulating tolerability information to guide which doses are studied and which may be considered for later evaluation. The aim differs from a conventional treatment comparison: rather than estimating a difference in clinical outcome between groups, the immediate focus is on selecting a dose under predefined safety rules. For this study, the primary outcome description says that recommended Phase 2 doses of decitabine would be determined from numbers of participants with treatment-related adverse events. The actual dose-escalation algorithm and its decision thresholds are not reported in the registry record.
What the cohort entries represent
The registry lists each cohort with a participant count and a dose value in mg/m² when available. Those values describe the dose-finding record, not a mean, a response rate, or a comparison effect. The repeated 20.0 mg/m² entries should remain separate cohort results rather than being combined into a new summary. Combining them would require assumptions about cohort structure and the dose-escalation procedure that are not described in the record.
Several later-listed cohorts have no participants and no value. Such entries indicate that no result is recorded for those cohorts; they do not establish why the cohorts were not populated or whether a particular stopping rule was triggered. The reason is not reported in the registry record. Likewise, the record does not describe the talazoparib dose corresponding to each posted decitabine value, so the entries do not fully characterize combination dose levels.
Why adverse-event criteria matter
In general, using a named adverse-event grading system creates a shared framework for classifying event severity. Here, the outcome description names Version 4.0 of the NCI Common Terminology Criteria for Adverse Events and says the dose decision was based on treatment-related adverse events. That framing is important because event attribution and severity classification can affect which events count toward dose selection. The posted results do not give the event-level classifications, the treatment-related event counts by cohort, or the procedure used to attribute events to treatment. It is therefore not possible to reproduce the dose-selection process from the cohort values alone.
Why comparative estimates are unavailable
For a two-group clinical comparison, a treatment-effect estimate generally needs a defined outcome for each group and an analysis that accounts for the design. A confidence interval describes the range of effects compatible with the data under the analysis assumptions; a p-value assesses compatibility with a specified null hypothesis. These are general statistical concepts. The registry lists no analyses and no comparative estimates for this outcome. It also notes that values are missing or not estimable for a two-arm comparison because the endpoint is a count-other endpoint. Accordingly, no comparative effect or uncertainty interval can be interpreted from the posted results.
The registry classifies allocation as randomized and the model as factorial, but it does not explain the factors, allocation scheme, or the relation between those design labels and the reported Phase 1 cohorts. In general, randomized allocation can support a comparison by reducing systematic differences between groups, while a factorial design can evaluate multiple treatment factors. Those strengths depend on the actual design and analysis. Without the relevant details or posted analysis, the classifications alone do not establish a particular treatment contrast.
Planning calculations and observed evidence
In general, sample-size calculations depend on a target effect, variability assumptions, significance level, allocation, and analysis method. A planning calculation is not an observed result and is not evidence that a trial had a particular chance of detecting its true effect. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as a fraction of the observed effect. But no two-arm effect is available for this count-other endpoint, so the listed results do not support a comparative planning illustration. No sample-size justification for the trial itself is reported in the registry record.
The study’s enrollment and cohort counts describe the number of participants recorded, not the precision of an efficacy estimate. Precision would require an appropriate outcome estimate and measures of uncertainty. Neither is posted for a comparative clinical outcome. The registry record also does not report an interim-analysis plan, a prespecified inferential analysis, or a method for handling repeated evaluations during dose escalation. These omissions prevent a fuller assessment of the statistical properties of the dose-selection process.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when an analysis makes several statistical comparisons or tests, increasing the chance that at least one result appears unusual by chance. In general, trial protocols may address this through a hierarchy of outcomes, adjusted significance thresholds, or another prespecified strategy. The registry lists one primary dose-finding outcome and no posted secondary outcomes, but it describes multiple cohorts and Phase 2 populations. The relationship of those features to any planned set of statistical tests is not reported in the registry record. No multiplicity adjustment or testing hierarchy is reported.
The registry lists no analyses for the posted outcome. It therefore provides no inferential results for which to assess multiplicity correction. This absence should not be interpreted as evidence that no analyses were conducted outside the registry; their details are not reported in the registry record.
Methods for missing data are also not reported in the registry record. The cohort listings include entries with zero participants and no dose value, but the record does not state whether those entries represent planned cohorts, uninitiated cohorts, or another status. It does not describe participant withdrawals, incomplete adverse-event assessments, or how missing safety information would be handled.
The analysis populations are not defined beyond the primary outcome’s description of 25 patients with relapsed or refractory acute myeloid leukemia. The record does not say whether results use all enrolled participants, participants who received treatment, or another population. It also does not describe exclusions or protocol deviations. These details matter because the number analyzed and the rules for including participants can affect the interpretation of safety summaries and any planned dose decision.
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 |
|---|---|---|---|
| Phase 1 Dose Escalation | 25 | 25 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase 1 Dose Escalation | 2 of 25 |
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 |
|---|---|
| Phase 1 Dose Escalation | 25 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase 1 Dose Escalation |
|---|---|---|
| Fever | Infections and infestations | 19 of 25 |
| Infection | Respiratory, thoracic and mediastinal disorders | 15 of 25 |
| Sepsis/bacteremia | Infections and infestations | 12 of 25 |
| Respiratory | Respiratory, thoracic and mediastinal disorders | 8 of 25 |
| Other infections | Infections and infestations | 8 of 25 |
| Hyperbilirubinemia | Hepatobiliary disorders | 4 of 25 |
| Atrial fibrillation | Cardiac disorders | 3 of 25 |
| Fungal infection | Infections and infestations | 2 of 25 |
| Intracranial bleed | Nervous system disorders | 2 of 25 |
| Diarrhea | Gastrointestinal disorders | 2 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase 1 Dose Escalation |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | 13 of 25 |
| Nausea | Gastrointestinal disorders | 12 of 25 |
| Vomiting | Gastrointestinal disorders | 10 of 25 |
| Respiratory | Respiratory, thoracic and mediastinal disorders | 9 of 25 |
| Other infections | Infections and infestations | 5 of 25 |
| Atrial fibrillation | Cardiac disorders | 3 of 25 |
| Transaminitis | Hepatobiliary disorders | 3 of 25 |
| Fever | Immune system disorders | 2 of 25 |
| Elevated creatinine | Renal and urinary disorders | 2 of 25 |
| Other infections | Infections and infestations | 1 of 25 |
Serious events with the highest arm-level rate: fever (76.0%), infection (60.0%), sepsis/bacteremia (48.0%), respiratory (32.0%), other infections (32.0%).
The safety record lists 25 participants at risk for serious adverse events and 25 affected. It separately lists 25 at risk for other adverse events and 25 affected. These figures describe the registry’s participant-level at-risk and affected counts; they do not provide the number of events per participant or the duration of observation. The registry also records 2 deaths, without giving causes or a treatment attribution in the posted information.
The listed serious-event terms and percentages are fever, 76.0%; infection, 60.0%; sepsis/bacteremia, 48.0%; respiratory, 32.0%; other infections, 32.0%; and hyperbilirubinemia, 16.0%. The registry does not clarify in the posted results whether these categories overlap, how repeated events were counted, or the exact denominator and reporting window for each percentage. They should not be added together or treated as mutually exclusive categories.
These safety summaries do not compare the combination with another treatment. They also do not show whether events occurred at a particular dose or cohort. The registry does not report the cohort-specific event counts needed to connect these safety summaries to the dose-finding decisions.
12. What the Result Does, and Does Not, Mean
The record documents a Phase 1/2 study of decitabine and talazoparib and reports Phase 1 cohort-level dose values, participant counts, and safety summaries. It shows that the posted dose-finding record included values of 10.0, 15.0, and 20.0 mg/m², with cohort sizes varying across the listed cohorts. It also records serious and other adverse events affecting the participants at risk, and 2 deaths.
Those findings do not establish whether the combination improves outcomes for acute myeloid leukemia. The posted results do not include response, survival, or other comparative clinical outcome analyses. Nor do they establish that one dose is more effective or safer than another. There is no comparator result or inferential estimate to support such a conclusion.
The results also do not independently identify the recommended Phase 2 dose. Although dose selection is the stated purpose of the primary outcome, the registry record does not provide the final selection, treatment-related adverse-event counts by cohort, or decision rule. The cohort values alone cannot be used to infer that a particular dose was selected or why.
In general, dose-finding evidence can inform the design of later studies, but its usefulness depends on the completeness of the dose and safety reporting and on the rules used to act on accumulating data. Here, the registry record makes the studied cohort values and overall safety counts visible, while leaving key elements of the decision process unreported. Interpretation should therefore remain descriptive and limited to the recorded information.
The study’s randomized and factorial classifications do not change that boundary. Without the allocation details, the intended factorial contrasts, and posted comparative analyses, those design labels do not yield a treatment-effect estimate. The record is most informative as a report of dose-finding activity and safety summaries, not as evidence of comparative efficacy.
13. Why This Trial Matters Statistically
Dose selection is a statistical problem as well as a clinical one. The amount of information available in each cohort, the definition of a dose-limiting or treatment-related event, and the rules for moving between dose levels all shape what can be inferred. The registry identifies adverse events as the basis for selecting recommended Phase 2 doses, but does not report the specific algorithm or cohort-level event counts. That gap illustrates why posting cohort sizes and dose values is not equivalent to providing a reproducible dose-selection analysis.
The record also illustrates the difference between a trial’s design labels and the analyses that can be interpreted from its results. Randomized allocation and a factorial model are listed, but the posted outcome is organized as Phase 1 dose-finding cohorts and has no comparative analyses. Statistical interpretation depends on the actual contrast, outcome, and analysis, not on design labels alone.
Finally, safety summaries can be important while still leaving uncertainty about their detail and context. Overall counts and listed event terms communicate what was recorded, but without cohort-level event data, observation windows, and attribution details, readers cannot trace the safety information back to dose-selection decisions. Clear reporting of those elements helps researchers assess how a dose was chosen and what evidence should guide subsequent studies.
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 primary limitation is that the registry’s dose-finding outcome is not accompanied by treatment-related adverse-event counts by cohort or by a stated dose-selection rule. The record therefore does not show how the recommended Phase 2 dose was determined, despite identifying dose selection as the outcome’s purpose. The posted cohort entries also do not report corresponding talazoparib doses.
The registry provides no comparative clinical outcome analyses, and no analyses are listed. This prevents estimation of an effect relative to a comparator and limits interpretation to descriptive dose and safety information. Although allocation is labeled randomized and the model factorial, the details of the allocation and factorial structure are not reported in the registry record.
The safety results lack several details needed for a fuller assessment: event timing, event counts, cohort-specific distributions, causes of death, and the exact denominator and reporting window for the listed percentages are not reported in the registry record. The record also does not describe missing-data handling, analysis populations, interim analyses, or the trial’s own sample-size justification.
The Phase 2 populations are described, but comparative Phase 2 outcomes are not posted. The record’s enrollment of 25 and its small, varying cohort sizes also mean that the posted results should not be treated as a precise estimate of a treatment effect. No such estimate is reported. These limitations are specific to the available registry results and do not establish what may have been analyzed or reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Decitabine and Talazoparib in Untreated AML and R/R AML — NCT02878785.
- Registry record last updated 2023-03-29; status last verified 2022-05.
- Results first posted 2022-06-23.
- 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
This completed Phase 1/2 study evaluated decitabine with talazoparib for acute myeloid leukemia, with enrollment of 25. The primary posted outcome concerns Phase 1 dose finding: selecting recommended Phase 2 doses of decitabine based on numbers of participants with treatment-related adverse events assessed using Version 4.0 of the NCI Common Terminology Criteria for Adverse Events. The registry lists cohort-level values of 10.0, 15.0, and 20.0 mg/m², along with participant counts.
The record reports 25 participants at risk for and affected by serious adverse events, 25 at risk for and affected by other adverse events, and 2 deaths. It lists no analyses and no secondary outcomes. Comparative efficacy results, cohort-specific event counts, and the final dose-selection rationale are not reported in the registry record. The posted information therefore supports descriptive reading of the dose-finding and safety entries, not a comparative estimate of treatment benefit.