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 Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1 (NCT03837353), a non-randomized phase 1, phase 2 study. The primary outcome is Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03837353 |
| Phase | Phase 1, Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic castration-resistant prostate cancer who were biomarker positive for Dickkopf-1 (DKK1) in plasma or biopsy. The study record describes advanced prostate cancer with elevated DKK1. Other biopsies for correlative studies were encouraged but not mandatory.
Intervention
DKN-01 as monotherapy, or DKN-01 combined with docetaxel. The study included dose-escalation and dose-expansion cohorts. In combination cohorts, docetaxel was fixed at 75 mg/m2 while DKN-01 dosing varied by cohort and dose level.
Comparator
There was no randomized control group. The study used parallel, non-randomized cohorts, so the treatment groups are not a like-for-like control comparison. The record does not report a separate standard-care comparator.
Primary question
The primary endpoint counted dose-limiting toxicities observed by the end of treatment cycle 1 in the Phase I dose-escalation cohorts. The record describes this endpoint but does not report its mean, standard deviation, or cohort-level outcome values. The endpoint was intended to inform dose escalation and dose expansion, rather than to establish a comparative treatment effect.
3. Trial Design
This was a Phase 1b/2a, parallel-arm, non-randomized study sponsored by NYU Langone Health. It enrolled 18 participants and is listed as terminated. The recorded start date is 2019-04-01, and the primary completion date is 2022-07-19. The masking field is none. The record describes the study as a multicenter dose-escalation and dose-expansion investigation in patients with metastatic castration-resistant prostate cancer and elevated DKK1.
Four cohorts are described. Cohort 1A escalated DKN-01 in combination with a fixed docetaxel dose of 75 mg/m2. The DKN-01 levels included 300 mg, 600 mg, or 150 mg, with escalation or de-escalation depending on identified dose-limiting toxicities. Cohort 1B was a combination dose-expansion cohort, using the maximum tolerated dose or highest dose tested in Cohort 1A. Some administration details in the cohort description are incomplete in the registry record.
Cohort 2A evaluated DKN-01 monotherapy through dose escalation, with the same stated DKN-01 levels of 300 mg, 600 mg, or 150 mg. The description specifies dosing on Days 1 and 15 of each 28-day cycle. Cohort 2B was a monotherapy dose-expansion cohort using the maximum tolerated dose or highest dose tested in Cohort 2A, with dosing on Days 1 and 15 of each 28-day cycle. Treatment was described as continuing until PCWG3 progression or unacceptable toxicity.
The primary endpoint was assessed in Phase I dose-escalation arms 1A.1, 1A.2, 2A.1, and 2A.2 only. Secondary outcomes listed were progression-free survival, participants with a PSA decline of at least 50% relative to baseline, and maximal percent change in PSA after treatment initiation.
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 | Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2) | Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2) | Cohort 1B (DKN-01 600mg [Phase II Dose], Docetaxel 75 mg/m2) | Cohort 2A.1 (DKN-01 300mg) | Cohort 2A.2 (DKN-01 600mg) | Cohort 2B (DKN-01 600mg [Phase 2 Dose]) |
|---|---|---|---|---|---|---|
| STARTED | 3 | 3 | 2 | 4 | 3 | 3 |
| COMPLETED | 3 | 3 | 2 | 4 | 3 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
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.
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2) | Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2) | Cohort 1B (DKN-01 600mg [Phase II Dose], Docetaxel 75 mg/m2) | Cohort 2A.1 (DKN-01 300mg) | Cohort 2A.2 (DKN-01 600mg) | Cohort 2B (DKN-01 600mg [Phase 2 Dose]) |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 2 | 4 | 3 | 3 | |
| Age, Continuous | years | 66 (59 to 67) | 68 (67 to 71) | 76 (72 to 80) | 65 (57 to 83) | 74 (72 to 78) | 64 (60 to 65) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 2 | 4 | 3 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 3 | 0 | 4 | 3 | 2 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 1 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 2 | 1 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 3 | 2 | 2 | 2 | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 0 | 0 | 1 |
| Region of Enrollment: United States | participants | 3 | 3 | 2 | 4 | 3 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1, measured over Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Number of events |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the number of dose-limiting toxicities observed by the end of treatment cycle 1. The registry describes the outcome as a count of events and specifies that it is summarized using a mean and standard deviation. The assessment timeframe is up to the end of cycle 1: up to Day 21 for Cohort 1A and up to Day 28 for Cohort 2A. It applies only to the Phase I dose-escalation arms 1A.1, 1A.2, 2A.1, and 2A.2.
In dose-escalation research, dose-limiting toxicity is used to inform whether a dose level can be advanced, should be held, or should be reduced. This is a general description of the role of the endpoint; the registry record does not provide the study’s detailed dose-limiting toxicity criteria or decision rules. The endpoint therefore addresses early tolerability within the escalation cohorts, not long-term safety or comparative effectiveness.
The registry record does not report the observed mean, standard deviation, or dose-limiting toxicity count for the primary endpoint. Without those outcome values, the posted record does not support a quantitative estimate of the observed endpoint or a comparison across dose levels. The title and endpoint definition identify what was measured, but they do not themselves establish the observed frequency or severity of toxicities.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, non-randomized dose-escalation and dose-expansion study, with 18 participants enrolled. Its primary endpoint concerns dose-limiting toxicities during the first treatment cycle in specified Phase I arms. However, the record does not report the primary endpoint’s observed values, mean, or standard deviation. The outcome’s magnitude and variation therefore cannot be assessed from the posted primary endpoint information.
The study’s design is suited to evaluating dose levels within an early-phase framework, but the non-randomized parallel cohorts do not provide a like-for-like control comparison. Differences between cohorts, if observed in other results, could reflect their differing treatment regimens, dose levels, or participant composition as well as treatment. The registry record does not report a randomized contrast or an adjusted comparison that would address those issues. A causal treatment-effect interpretation is not supported by the design information alone.
The record lists secondary outcomes of progression-free survival, PSA response, and maximal PSA change after treatment initiation. It does not report analyses for these outcomes in the material described in the registry record. The number of analyses is recorded as zero. This means the registry entry as posted does not provide inferential results for those outcomes; it does not establish what analyses may have been conducted outside the registry.
Safety information is reported by treatment group, including participants at risk and counts affected by serious and other adverse events. Those counts are descriptive. They should not be read as evidence that a treatment caused or prevented an event, particularly without a randomized control group and without fuller context on event definitions, follow-up, and participant-level overlap. The listed serious-event terms and percentages also require caution because their denominator and calculation details are not reported in the registry record.
Overall, the posted information identifies the study population, regimens, endpoint, and selected safety counts, but it does not provide the primary endpoint results or analysis estimates. It can therefore characterize the study’s design and the limits of the reported evidence, but it cannot quantify the primary endpoint, establish a comparative effect, or support a definitive interpretation of efficacy or safety.
9. Statistical Methods Explained
The registry identifies a continuous-outcome summary for the primary endpoint: the mean number of dose-limiting toxicities, with standard deviation as the measure of dispersion. The endpoint itself is a count. A mean expresses the average count across the assessed participants, while a standard deviation describes how much individual observations vary around that average. These are general statistical explanations. The registry record does not report the numerical mean or standard deviation for this endpoint, so neither can be interpreted quantitatively.
What does the endpoint population include?
The primary endpoint is restricted to the Phase I dose-escalation arms 1A.1, 1A.2, 2A.1, and 2A.2. It is not described as an outcome for every enrolled participant or every cohort. The record gives the relevant assessment windows as up to Day 21 for Cohort 1A and up to Day 28 for Cohort 2A. These different windows matter when reading the outcome: an event count is tied to its observation period, and counts collected over different periods are not automatically comparable. This is a general consideration, not evidence that the registry performed a cross-cohort comparison.
The registry’s endpoint description does not specify the detailed criteria for classifying an event as dose limiting, how events were attributed to treatment, or how participants without a complete first-cycle assessment were handled. Each of those details can affect the interpretation of an endpoint count. They are not reported in the registry record and should not be inferred from the endpoint title.
How should a mean and standard deviation be read for a count?
A mean can summarize the average number of events, but the underlying observations are counts and cannot take negative values. General statistical methods for count outcomes may therefore consider the distribution of the counts rather than assuming that they behave like an unrestricted continuous measure. With limited observations, a mean and standard deviation may also be sensitive to individual participants with higher counts. The posted record does not include the participant-level observations or a distributional summary that would permit checking these features.
Over-dispersion is a general count-data issue: it occurs when the variability in counts is greater than a simple count model expects. If over-dispersion is present, standard errors from a model that assumes less variability can be too small, and confidence intervals can be too narrow. The registry record does not report a count model, an over-dispersion assessment, or a model-based estimate for the primary endpoint. It would be inappropriate to claim that such methods were used.
What can the adverse-event counts establish?
The safety record gives, for each listed group, the number at risk, the number affected by serious adverse events, the number at risk for other adverse events, the number affected by other adverse events, and deaths. These are descriptive counts. They can convey how many participants were recorded in each category, but they are not an adjusted comparison and do not account for differences in follow-up or participant characteristics. The record does not provide event-level timing, duration, recurrence, or participant overlap between categories. The serious-event terms are accompanied by percentages, but the basis for those percentages is not reported in the registry record.
General interpretation of a safety count depends on knowing what was counted and over what observation period. A participant count affected is different from a count of all events if a participant can have repeated events. The registry’s displayed wording distinguishes participants affected for the group-level counts, but does not give enough detail to reconstruct event histories. The counts should therefore be read as registry summaries, not as complete estimates of event incidence or risk.
What do the planning illustrations mean?
The study’s sample-size assumptions describe a 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. The target effect is described as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm for 80% or 90% power; time-to-event illustrations use a total event count. These assumptions describe the illustrations, not the original trial design. Sample-size illustrations are planning aids and are not observed power. The registry record does not report the trial’s own sample-size justification, so the illustration should not be interpreted as evidence of the study’s prespecified design rationale.
Because the primary endpoint estimates and analyses are not reported, no confidence interval or hypothesis test for that endpoint can be described from the registry record. In general, a confidence interval communicates the precision of an estimate across values compatible with the analysis; its width depends on the data and method. It is not a range containing a known fixed proportion of individual participant outcomes. No interval should be inferred where none is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes in addition to the primary dose-limiting toxicity endpoint: progression-free survival, a PSA decline of at least 50% relative to baseline, and maximal percent change in PSA after treatment initiation. The record also lists five outcome measures overall, but it does not provide analyses for the listed outcomes; the number of analyses is recorded as zero. Outcome names alone do not indicate whether results were tested, how comparisons were defined, or what estimates were obtained.
Multiplicity arises generally when several outcomes, dose levels, or comparisons are examined. Without a stated analysis plan, readers cannot determine whether any adjustment for multiple testing was planned, whether outcomes were ranked, or whether findings were exploratory. Such details are not reported in the registry record. No correction method or prespecified hierarchy should be assumed.
The record does not report how missing endpoint or follow-up data were handled, the number of participants with evaluable primary endpoint data, or the analysis populations used for each outcome. It also does not specify whether participants were included according to treatment received, intended cohort, or another population definition. These omissions limit assessment of completeness and possible selection effects. The enrollment figure alone does not establish how many participants contributed to each analysis.
In general, missing-data methods can influence estimates when the availability of an outcome is related to participant status or treatment. Without a description of missingness and analysis populations, the direction or size of any such influence cannot be assessed. The registry record does not report sensitivity analyses or procedures for handling incomplete assessments.
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 |
|---|---|---|---|
| DKN-01 300mg, Docetaxel 75 mg/m2 | 1 | 3 | 33.3% |
| DKN-01 600mg, Docetaxel 75 mg/m2 | 1 | 5 | 20.0% |
| DKN-01 300mg | 0 | 4 | 0.0% |
| DKN-01 600mg | 2 | 6 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DKN-01 300mg, Docetaxel 75 mg/m2 | 0 of 3 |
| DKN-01 600mg, Docetaxel 75 mg/m2 | 0 of 5 |
| DKN-01 300mg | 0 of 4 |
| DKN-01 600mg | 0 of 6 |
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 |
|---|---|
| DKN-01 300mg, Docetaxel 75 mg/m2 | 3 of 3 |
| DKN-01 600mg, Docetaxel 75 mg/m2 | 5 of 5 |
| DKN-01 300mg | 4 of 4 |
| DKN-01 600mg | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | DKN-01 300mg, Docetaxel 75 mg/m2 | DKN-01 600mg, Docetaxel 75 mg/m2 | DKN-01 300mg | DKN-01 600mg |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 0 of 3 | 0 of 5 | 0 of 4 | 1 of 6 |
| Clostridium Difficile (Serious Adverse Event) | Infections and infestations | 1 of 3 | 0 of 5 | 0 of 4 | 0 of 6 |
| Pain | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 5 | 0 of 4 | 1 of 6 |
| Spinal Fracture | Musculoskeletal and connective tissue disorders | 0 of 3 | 1 of 5 | 0 of 4 | 0 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DKN-01 300mg, Docetaxel 75 mg/m2 | DKN-01 600mg, Docetaxel 75 mg/m2 | DKN-01 300mg | DKN-01 600mg |
|---|---|---|---|---|---|
| Fatigue | General disorders | 2 of 3 | 4 of 5 | 3 of 4 | 3 of 6 |
| Nausea | Gastrointestinal disorders | 2 of 3 | 3 of 5 | 1 of 4 | 5 of 6 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 5 | 2 of 4 | 4 of 6 |
| Constipation | Gastrointestinal disorders | 2 of 3 | 1 of 5 | 1 of 4 | 2 of 6 |
| Alopecia | General disorders | 3 of 3 | 2 of 5 | 0 of 4 | 0 of 6 |
| Anorexia | General disorders | 0 of 3 | 2 of 5 | 1 of 4 | 2 of 6 |
| Musculoskeletal/connective tissue disorder | Musculoskeletal and connective tissue disorders | 0 of 3 | 0 of 5 | 3 of 4 | 2 of 6 |
| Peripheral sensory neuropathy | Nervous system disorders | 0 of 3 | 3 of 5 | 0 of 4 | 2 of 6 |
| Aspartate aminotransferase (AST) levels increased | Hepatobiliary disorders | 0 of 3 | 2 of 5 | 1 of 4 | 1 of 6 |
| Atrial fibrillation | Cardiac disorders | 1 of 3 | 3 of 5 | 0 of 4 | 0 of 6 |
Serious events with the highest arm-level rate: clostridium difficile (serious adverse event) (33.3%), spinal fracture (20.0%), acute kidney injury (16.7%), pain (16.7%).
The adverse-event record lists four treatment groups and reports the number at risk, the number affected by serious adverse events, the number at risk for other adverse events, the number affected by other adverse events, and deaths. For DKN-01 300mg with Docetaxel 75 mg/m2, the serious-event count is 1 of 3 at risk and the other-event count is 3 of 3; deaths are 0. For DKN-01 600mg with Docetaxel 75 mg/m2, the corresponding counts are 1 of 5 and 5 of 5; deaths are 0. For DKN-01 300mg, they are 0 of 4 and 4 of 4; deaths are 0. For DKN-01 600mg, they are 2 of 6 and 6 of 6; deaths are 0.
The listed serious adverse-event terms include Clostridium Difficile (Serious Adverse Event) at 33.3%, Spinal Fracture at 20.0%, Acute kidney injury at 16.7%, and Pain at 16.7%. The registry record does not report the denominator or calculation details for these percentages, so they should not be converted into participant counts or compared across groups. The term list and group-level counts are descriptive and do not establish causation.
These counts do not account for treatment duration, event recurrence, or differences between the non-randomized groups. The record also does not report detailed event timing or participant-level overlap between serious and other adverse events. The reported deaths are 0 in each listed group, which describes the registry entries and should not be generalized beyond the recorded groups and information.
12. What the Result Does, and Does Not, Mean
The record establishes that this was a non-randomized Phase 1b/2a study of DKN-01, either alone or with docetaxel, in patients with metastatic castration-resistant prostate cancer and elevated DKK1. It identifies four dose-escalation and dose-expansion cohorts, an enrollment of 18, and a primary endpoint focused on dose-limiting toxicities by the end of cycle 1 in specified dose-escalation arms. It also provides selected adverse-event counts by group.
Those details do not reveal the observed primary endpoint result. The registry record does not report the mean number of dose-limiting toxicities or its standard deviation. Nor does it report inferential analyses for the listed secondary outcomes. Without those results, the posted record cannot quantify the primary endpoint, characterize the precision of an estimated treatment effect, or establish how progression-free survival or PSA outcomes varied.
The non-randomized design also means that the cohorts should not be treated as equivalent groups differing only in regimen. The record does not describe a randomized control comparison. Descriptive differences between dose levels or treatment groups, if considered, would not by themselves show that a regimen caused an outcome difference. The safety counts similarly report what was recorded in each group; they do not establish that a treatment caused or prevented any listed event.
The primary endpoint serves an early dose-escalation purpose. It is not, on its own, a measure of long-term benefit, and a count during the first cycle does not summarize all possible safety outcomes. The posted record does not provide the detailed toxicity criteria or complete follow-up needed for broader conclusions. The sound interpretation is therefore bounded: the registry describes the study question and selected observations, while leaving the primary efficacy and dose-limiting toxicity results unreported.
13. Why This Trial Matters Statistically
This study is statistically notable as an early-phase investigation that combines dose escalation with dose expansion across monotherapy and combination cohorts. Its primary outcome is an early count of dose-limiting toxicities, a measure connected to dose selection rather than a randomized estimate of comparative benefit. The record’s structure makes it important to distinguish the question a dose-escalation endpoint addresses from questions about long-term outcomes or comparative effectiveness.
The biomarker requirement also defines the population to which the study question applies: participants needed to be DKK1 positive in plasma or biopsy. That feature is central to interpreting the intended study population, but the registry does not report outcome estimates by biomarker measurement or level. It would therefore be inappropriate to infer a biomarker-outcome relationship from the eligibility description alone.
The non-randomized, parallel cohort design highlights a general statistical challenge. Different dose levels and treatment regimens may be evaluated in separate groups, but group comparisons can reflect more than the assigned regimen. Without random allocation and a reported analysis addressing differences between groups, descriptive contrasts have limited causal meaning.
The registry’s lack of primary endpoint results is also consequential. A clearly named endpoint and a detailed cohort structure do not replace reporting the observed estimates and their uncertainty. The record provides context for what the investigators intended to measure, but not the quantitative primary result needed to assess its magnitude or precision. This distinction is important for readers evaluating early-phase evidence: design information can clarify the purpose of an investigation without supplying the results needed to judge what was observed.
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 for interpretation is that the registry record describes the primary endpoint but does not report its observed mean, standard deviation, or cohort-level values. The record also lists no analyses, leaving no reported statistical estimates for the secondary outcomes. As a result, the posted information cannot quantify the endpoint or its precision.
The study was non-randomized and had no masking. Its parallel cohorts are not a like-for-like control comparison. Differences across cohorts may reflect the regimen, dose level, or participant characteristics, and the record does not report a comparative analysis that would resolve these potential sources of variation. The enrollment was 18, but the number contributing to each endpoint analysis is not reported in the registry record.
The registry’s cohort descriptions are incomplete in places. For example, the Cohort 1A description ends before the full administration schedule is given, and the Cohort 1B description is also incomplete. The record does not provide detailed dose-limiting toxicity criteria, a full statistical analysis plan, or a reported sample-size justification. These details should not be reconstructed from the abbreviated descriptions.
The safety summaries lack event timing, recurrence, follow-up duration by participant, and details about overlap among affected participants. The denominator and calculation basis for the listed serious-event percentages are not reported in the registry record. Missing-data procedures, analysis populations, and methods for addressing multiplicity are also not reported. These limitations constrain interpretation of both the descriptive safety information and any broader outcome question.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1 — NCT03837353.
- Registry record last updated 2023-12-18; status last verified 2023-12.
- Results first posted 2023-12-18.
- 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 describes a non-randomized, parallel Phase 1b/2a study sponsored by NYU Langone Health, with 18 participants enrolled. The study evaluated DKN-01 monotherapy and DKN-01 combined with docetaxel in patients with metastatic castration-resistant prostate cancer who were DKK1 positive. It included dose-escalation and dose-expansion cohorts and is listed as terminated.
The primary endpoint was the number of dose-limiting toxicities observed by the end of cycle 1 in specified Phase I dose-escalation arms, summarized as a mean and standard deviation. The registry record does not report the primary endpoint results. It lists secondary outcomes for progression-free survival and PSA change, but reports no analyses. Group-level adverse-event counts and selected serious-event terms are recorded, with limitations in the detail available for interpreting them.