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 A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer (NCT04019327), a na phase 1, phase 2 study. The primary outcome is Phase I: Number of Toxicities From Participants Evaluated for Treatment-Emergent Adverse Events/Toxicities [Safety and Tolerability]).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04019327 |
| Phase | Phase 1, Phase 2 |
| Condition | Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with metastatic castration-resistant prostate cancer and no mutations in DNA damage repair, as described in the arm information. The registry lists an enrollment of 16. Further eligibility details and the characteristics of participants included in each analysis are not reported in the registry record.
Intervention
The intervention was intermittent talazoparib plus temozolomide. The registry describes several dose levels combining different doses of the two drugs. The clinical purpose was to determine a safest dose, with Phase II intended to test efficacy at the maximum tolerated dose. The exact treatment schedule is not reported in the registry record beyond the description as intermittent.
Comparator
There was no separate control group. The study is recorded as single-group, with allocation listed as not applicable and masking as none. The dose-level groups are not a randomized, like-for-like comparison; differences between their posted outcomes should not be interpreted as causal treatment contrasts.
Primary question
The listed primary endpoint is the number of toxicities among participants evaluated for treatment-emergent adverse events or toxicities, classified by severity using NCI CTCAE v5.0. The stated timeframe is 30 days after the last dose of study treatment, with a tolerance of 3 days, up to 1 year. The registry also describes a Phase II efficacy objective, but a Phase II efficacy endpoint and its result are not reported in the registry record.
3. Trial Design
This was a Phase Ib/II study of intermittent talazoparib plus temozolomide in metastatic castration-resistant prostate cancer. The registry records the study as single-group, with no masking and no allocation scheme. Its listed enrollment is 16. Although adverse-event summaries are separated by dose level, the record does not describe these groups as randomized treatment arms or as a controlled comparison.
The study had a dose-finding purpose in Phase I: the brief summary says it sought to determine the safest dose of the combination. The Phase II purpose was to test efficacy at the maximum tolerated dose. The registry lists four dose-level descriptions: talazoparib 1mg with temozolomide 37.5 mg/m^2; talazoparib 0.75mg with temozolomide 50 mg/m^2; talazoparib 1mg with temozolomide 50 mg/m^2; and talazoparib 1mg with temozolomide 75 mg/m^2. The record does not explain how participants were assigned among those levels or whether dose changes followed a particular protocol.
The recorded start date is 2019-07-11, and the listed primary completion date is 2025-12-04. The study status is terminated. The reason for termination, whether follow-up was complete for every participant, and whether the planned Phase II objective was carried out are not reported in the registry record. The record gives no inferential analyses and no analysis population definitions. Consequently, the design can be described from its registry fields, but the conduct and rationale behind dose-level progression cannot be reconstructed from the posted information.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | Dose Level 2 Tala 1mg, TMX 75 mg/m^2 |
|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 7 |
| COMPLETED | 0 | 2 | 2 | 3 |
| NOT COMPLETED | 3 | 1 | 1 | 4 |
Reasons for not completing this period:
| Reason | Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | Dose Level 2 Tala 1mg, TMX 75 mg/m^2 |
|---|---|---|---|---|
| Death | 3 | 1 | 1 | 3 |
| Study terminated by sponsor | 0 | 0 | 0 | 1 |
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.
| Characteristic | Unit | Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | Dose Level 2 Tala 1mg, TMX 75 mg/m^2 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 3 | 7 | 16 | |
| Age, Continuous | years | 66 (61 to 68) | 58 (58 to 87) | 70 (61 to 70) | 62 (57 to 72) | 64 (57 to 87) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 3 | 7 | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 2 | 3 | 5 | 13 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 2 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 2 | 3 | 3 | 5 | 13 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment: United States | Participants | 3 | 3 | 3 | 7 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Phase I: Number of Toxicities From Participants Evaluated for Treatment-Emergent Adverse Events/Toxicities [Safety and Tolerability]), measured over 30 days after last dose of study treatment (+/- 3 days), up to 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | toxicities |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of toxicities among participants evaluated for treatment-emergent adverse events or toxicities. The registry says that severity is classified using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. It gives the assessment window as 30 days after the last dose of study treatment, with a tolerance of 3 days, up to 1 year.
A toxicity count is intended to capture safety events during treatment and the stated follow-up window. Unlike an endpoint that records only whether a participant experienced any event, a count can represent multiple events; however, the registry description does not clarify whether repeated events of the same type are counted separately, how events are attributed to treatment, or how severity categories are summarized. Those details are not reported in the registry record.
This endpoint fits the Phase I safety and tolerability purpose described in the study summary. It is not, by itself, an efficacy measure. Although the record states that Phase II was intended to test efficacy at the maximum tolerated dose, the efficacy endpoint, its analysis method, and its result are not reported in the registry record. The posted safety summaries do not supply the primary endpoint’s overall toxicity count, so they should not be treated as a complete result for that endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a dose-finding study, not a randomized comparison of talazoparib plus temozolomide against a control treatment. Its single-group designation and allocation listed as not applicable are important when interpreting the four dose-level summaries. Those levels describe treatment combinations, but the record does not establish that participants were assigned comparably across levels. Differences in observed adverse events therefore cannot be attributed to dose differences alone.
The posted adverse-event summaries report serious adverse events in the highest listed dose level: 4 of 7 participants at risk were affected. The other three dose-level entries report 0 of 3 affected in each group. These are descriptive group figures, not estimates from a randomized comparison. The registry also reports other adverse events affecting 3 of 3, 2 of 3, 3 of 3, and 7 of 7 participants across the four listed dose levels. These are participant-level affected counts in the adverse-event summary and should not be confused with the primary endpoint’s number of toxicities, which can concern events rather than participants.
The record lists deaths as 3, 1, 1, and 3 across the four dose levels. It does not report the causes of death, their timing, or whether they were considered related to study treatment. Those counts cannot be interpreted as treatment-related mortality from this information alone. The serious-event terms listed include platelet count decreased, febrile neutropenia, anemia, chest pain - cardiac, neutrophil count decreased, and dehydration, with the percentages recorded alongside those terms. The denominator and derivation for those percentages are not explained in the registry record.
No statistical analyses are listed. There are no reported confidence intervals, hypothesis tests, adjusted estimates, or Phase II efficacy results in the registry record. Thus, the available information supports a descriptive account of recorded safety events by dose level, but not a precise estimate of comparative risk or an efficacy conclusion. The terminated status and absence of an explanation for termination add uncertainty about study completion and the intended Phase II assessment.
9. Statistical Methods Explained
Interpreting this study begins with its design. General statistical principle: a randomized control group helps distinguish treatment effects from differences in participant characteristics, clinical course, and other influences. This record describes a single-group study with no allocation scheme. Its dose-level groups are not a randomized, like-for-like comparison, so their outcome differences are descriptive rather than causal evidence that one dose combination is safer or more effective than another.
What does a count endpoint represent?
The listed primary endpoint is the number of toxicities among participants evaluated for treatment-emergent adverse events or toxicities. General statistical principle: a count endpoint can include more than one event per participant, whereas a proportion of participants affected records whether each participant experienced an event. These measures answer different questions. The adverse-event summary gives counts of participants at risk and affected, but the primary endpoint’s overall toxicity count is not reported in the registry record. The record also does not explain how repeated events, event attribution, or severity grades are handled in that count.
The stated observation window is 30 days after the last dose, with a tolerance of 3 days, up to 1 year. General statistical principle: a clearly specified observation window matters because the opportunity to record events depends on how long participants are followed. A common window supports more interpretable summaries than unequal follow-up, but the registry does not report individual follow-up duration or whether follow-up was complete. The study’s terminated status makes those omissions especially relevant to interpretation, although the reason for termination is not reported.
Why does the design limit dose comparisons?
General statistical principle: observed differences between groups can reflect both treatment differences and differences in who entered each group. Randomization is a way to balance such influences on average. The registry does not describe random assignment among dose levels. It also does not report the rules used to move between levels, participant characteristics by level, or whether the groups enrolled at different times. As a result, comparisons of serious adverse events or other adverse events across dose levels cannot isolate a dose effect.
Small group counts also make descriptive safety results sensitive to individual outcomes. General statistical principle: with limited observations, adding or removing one participant’s event can noticeably change a group proportion. The reported counts should therefore be read as what was recorded in those groups, not as stable estimates of the underlying event frequency. Confidence intervals could convey sampling uncertainty, but none are reported in the registry record. No interval should be inferred from the posted counts without an explicit recalculation and assumptions.
What can the adverse-event summaries establish?
The registry reports participants at risk and participants affected by serious and other adverse events for each dose level. Those summaries describe whether participants were recorded as affected; they do not provide the full event-level data needed to understand recurrence, duration, timing, severity, or attribution. General statistical principle: event counts and participant counts are not interchangeable. A participant may experience multiple events, while an affected-participant count records that participant once within the relevant summary. The record does not clarify every counting convention.
The serious-event terms are accompanied by percentages, but the registry does not explain their denominator or calculation. They should therefore be repeated as listed rather than reinterpreted as risks within a particular group or as percentages of all events. Similarly, the death counts appear in the adverse-event data, but the record does not report causes or treatment relationship. Statistical summaries alone cannot resolve those clinical classifications.
Where are the inferential results?
No analyses are listed in the registry record. It reports no model, test, confidence interval, adjusted effect, or formal comparison. General statistical principle: a confidence interval describes the range of effect estimates compatible with data and a specified method; it is useful for showing precision as well as direction. Without a reported estimate and interval, the precision of any treatment effect cannot be assessed from the record. The descriptive counts do not establish statistical significance or efficacy.
The registry’s Phase II objective was to test efficacy at the maximum tolerated dose, but the efficacy outcome and analysis are not reported in the registry record. The listed primary endpoint concerns toxicity, not tumor response or another efficacy measure. No planned sample-size justification, statistical analysis plan, interim-analysis procedure, or treatment of missing outcome data is reported. These omissions prevent assessment of whether the study had a prespecified inferential strategy or how incomplete observations were intended to be handled.
Any sample-size calculations presented as planning illustrations based on an observed effect are not observed power and do not show that the study was adequately powered. General statistical principle: retrospective calculations from an observed effect do not replace a prospective design justification and can give a misleading impression of certainty. The registry does not report its own sample-size rationale, so no conclusion about the intended precision or power can be drawn.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists no statistical analyses. It does not report a plan for handling multiplicity, such as how multiple outcomes, dose levels, or repeated safety assessments would be considered in formal testing. General statistical principle: when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for that multiplicity. Here, there are no reported hypothesis tests to evaluate, and the dose-level safety summaries should be treated descriptively rather than as a collection of confirmatory comparisons.
Missing-data procedures are not reported in the registry record. It does not say how participants without complete follow-up, unavailable toxicity assessments, or incomplete outcome records were handled. The record also does not provide analysis population definitions, such as which participants were included in the primary endpoint count or in the adverse-event summaries. Without those details, the relationship between the listed enrollment and the evaluable populations cannot be assessed.
General statistical principle: missingness can affect an estimate when the chance of having an observed outcome is related to participant characteristics or outcomes. The extent and pattern of missingness would be needed to evaluate that concern, but they are not reported in the registry record. The terminated status does not establish that data were missing or explain why the study ended; the reason for termination and the completeness of planned follow-up are not reported. No efficacy analysis population or missing-data method is available for the stated Phase II objective.
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 |
|---|---|---|---|
| Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | 0 | 3 | 0.0% |
| Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | 0 | 3 | 0.0% |
| Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | 0 | 3 | 0.0% |
| Dose Level 2 Tala 1mg, TMX 75 mg/m^2 | 4 | 7 | 57.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | 3 of 3 |
| Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | 1 of 3 |
| Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | 1 of 3 |
| Dose Level 2 Tala 1mg, TMX 75 mg/m^2 | 3 of 7 |
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 |
|---|---|
| Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | 3 of 3 |
| Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | 2 of 3 |
| Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | 3 of 3 |
| Dose Level 2 Tala 1mg, TMX 75 mg/m^2 | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | Dose Level 2 Tala 1mg, TMX 75 mg/m^2 |
|---|---|---|---|---|---|
| Platelet count decreased | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 4 of 7 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 2 of 7 |
| Anemia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 7 |
| Chest pain - cardiac | Cardiac disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 7 |
| Neutrophil count decreased | Investigations | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 7 |
| Dehydration | Metabolism and nutrition disorders | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 7 |
| White blood cell decreased | Investigations | 0 of 3 | 0 of 3 | 0 of 3 | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2 | Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2 | Dose Level 1B Tala 1mg, TMX 50 mg/m^2 | Dose Level 2 Tala 1mg, TMX 75 mg/m^2 |
|---|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 2 of 3 | 2 of 3 | 5 of 7 |
| Platelet count decreased | Blood and lymphatic system disorders | 0 of 3 | 1 of 3 | 2 of 3 | 7 of 7 |
| Nausea | Gastrointestinal disorders | 1 of 3 | 1 of 3 | 1 of 3 | 5 of 7 |
| White blood cell count decreased | Investigations | 0 of 3 | 1 of 3 | 2 of 3 | 4 of 7 |
| Diarrhoea | Gastrointestinal disorders | 1 of 3 | 1 of 3 | 1 of 3 | 3 of 7 |
| Neutrophil count decreased | Investigations | 0 of 3 | 0 of 3 | 2 of 3 | 4 of 7 |
| Anaemia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 5 of 7 |
| Constipation | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 1 of 3 | 3 of 7 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 3 | 1 of 3 | 3 of 7 |
| Pain | General disorders | 1 of 3 | 0 of 3 | 1 of 3 | 3 of 7 |
Serious events with the highest arm-level rate: platelet count decreased (57.1%), febrile neutropenia (28.6%), anemia (14.3%), chest pain - cardiac (14.3%), neutrophil count decreased (14.3%).
The adverse-event summaries give, for each dose level, the number at risk and the number affected by serious adverse events and by other adverse events. For serious events, the figures are 0 of 3, 0 of 3, 0 of 3, and 4 of 7 across the listed dose levels. For other adverse events, the figures are 3 of 3, 2 of 3, 3 of 3, and 7 of 7. These counts describe the registry’s group summaries; they are not randomized comparisons and do not establish that a dose level caused a difference.
The record separately lists deaths as 3, 1, 1, and 3 for the four dose levels. It does not report causes of death, timing, or whether the deaths were considered related to treatment. The listed serious-event terms and percentages are platelet count decreased at 57.1%, febrile neutropenia at 28.6%, and anemia, chest pain - cardiac, neutrophil count decreased, and dehydration at 14.3% each. The denominator for these percentages is not reported in the registry record, so they should not be interpreted as dose-specific risks.
These participant-level summaries are not the same as the primary endpoint’s number of toxicities. The latter is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted results show that adverse events were recorded across the four dose-level groups, including serious adverse events in the group described as talazoparib 1mg with temozolomide 75 mg/m^2. The registry also lists other adverse events and deaths by dose level. These observations describe the safety information entered in the record; they do not by themselves establish whether events were caused by treatment, whether a particular dose level is preferable, or whether the combination has an efficacy benefit.
The design does not support a controlled treatment-effect conclusion. This was recorded as a single-group study, with no allocation scheme and no masking. The dose levels are not a randomized control comparison. The groups may differ in ways the registry does not report, and there are no inferential analyses or precision estimates in the record. Accordingly, the posted figures should be understood as descriptive counts, not as evidence from a comparative effectiveness analysis.
The study’s stated Phase II purpose was to test efficacy at the maximum tolerated dose, but an efficacy endpoint and result are not reported in the registry record. The primary endpoint instead concerns the number of toxicities assessed using NCI CTCAE v5.0. Its overall result is also not reported in the information summarized by the registry fields. Thus, the available outcomes do not answer the efficacy question and do not provide a complete result for the listed primary endpoint.
The study is marked terminated, but the reason for termination and the completeness of follow-up are not reported. The record therefore leaves important questions about study conduct and outcome availability unresolved. The appropriate interpretation is limited to the recorded design and descriptive adverse-event information, with substantial uncertainty about comparative effects, event attribution, and efficacy.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a dose-finding objective and a controlled treatment comparison. In an early-phase study, safety and tolerability can be central, and dose-level summaries can describe the events recorded as treatment is explored. But a set of dose levels does not automatically create a valid head-to-head comparison. Without randomized assignment or a clearly reported alternative design, differences may reflect factors other than dose.
It also demonstrates why endpoint definitions matter. The primary endpoint is a number of toxicities, while the posted adverse-event summaries give the number of participants affected by serious and other adverse events. An event count and a count of affected participants are not the same quantity. Clear reporting of counting rules, observation windows, severity, attribution, and analysis populations is essential for readers to understand what a safety estimate represents.
The record’s Phase II efficacy objective is not accompanied by a reported efficacy endpoint or analysis result. That gap prevents readers from assessing whether the intended efficacy question was answered. The absence of listed statistical analyses, confidence intervals, and missing-data methods likewise limits evaluation of precision and robustness. These are not merely technical details: they determine whether descriptive observations can support a broader inference.
Finally, the terminated status underscores the importance of reporting study completion and reasons for changes in conduct. Since the reason for termination and the completeness of follow-up are not reported, readers cannot determine their implications for the available results. The record is therefore useful for identifying the study’s stated aims and recorded safety summaries, while also showing how incomplete analysis reporting constrains 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 registry identifies the study as terminated but does not report why it was terminated, whether recruitment or follow-up ended as planned, or whether the Phase II objective was completed. This leaves the status of the intended efficacy assessment unclear. The listed primary completion date is 2025-12-04, but the record does not explain how that date relates to termination or final outcome availability.
The primary endpoint is described as a number of toxicities, yet its overall result is not reported in the registry record. The safety summaries instead give participants at risk and affected by serious and other adverse events. Definitions for repeated events, treatment attribution, and the percentages accompanying serious-event terms are not reported. The death counts lack information on cause, timing, and relationship to treatment.
The record does not report how participants were assigned among dose levels, participant characteristics by group, detailed follow-up, analysis populations, or the amount and handling of missing data. Since the groups are not a randomized comparison, unadjusted differences between dose-level summaries cannot isolate the effect of dose. The record also lists no statistical analyses and gives no confidence intervals or formal efficacy results.
Further limitations include the absence of a reported sample-size justification, statistical analysis plan, interim-analysis information, and multiplicity approach. The absence of these details does not establish that such plans did not exist; they are simply not reported in the registry record. Together, these gaps limit assessment of precision, bias, completion, and the intended Phase II question.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer — NCT04019327.
- Registry record last updated 2026-08-24; status last verified 2025-12.
- Results first posted 2026-08-24.
- 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
The registry record describes a Phase Ib/II, single-group study of intermittent talazoparib plus temozolomide in metastatic castration-resistant prostate cancer without DNA damage repair mutations. Enrollment is listed as 16, and the study status is terminated. Four dose-level combinations appear in the adverse-event summaries.
The stated Phase I purpose was to determine a safest dose, and the stated Phase II purpose was to test efficacy at the maximum tolerated dose. The listed primary endpoint is the number of toxicities among participants evaluated for treatment-emergent adverse events or toxicities, classified by NCI CTCAE v5.0. The registry reports adverse-event counts by dose level, but no statistical analyses are listed.
The reason for termination, the overall primary endpoint result, Phase II efficacy endpoint and result, analysis populations, missing-data methods, and statistical plan are not reported in the registry record. The posted safety counts are descriptive and do not constitute a randomized comparison.