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 ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (NCT03300505), a na phase 1 study. The primary outcome is Number of Subjects With Dose-limiting Toxicity (DLT) During the First Cycle of ARRx (in Combination With Enzalutamide).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03300505 |
| Phase | Phase 1 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with metastatic castration-resistant prostate cancer. The registry lists enrollment as 9, but the publicly reported primary-endpoint population is not fully described: it states that a single participant was included at Dose Level 1 and that data are not reported publicly to protect confidentiality.
Intervention
Participants were assigned to receive ARRx, also called AZD5312 in the brief summary, in combination with enzalutamide. The registry describes intravenous ARRx dosing and daily enzalutamide in 21-day cycles, but the schedule description is truncated, so the full regimen cannot be reconstructed from the record.
Comparator
There was no separate control group. The record identifies a single-group model and allocation as not applicable. Dose Levels 1, 2, and 3 appear in the safety summaries, but they are not described as randomized, like-for-like comparison groups.
Primary question
The primary endpoint counts participants with dose-limiting toxicity during the first cycle, up to day 21 of treatment. A dose-limiting toxicity is defined as a qualifying Grade 3 or higher toxicity under CTCAE v5.0, with toxicity clearly and directly related to the primary disease or another etiology excluded. The public record does not report the primary count.
3. Trial Design
The registry describes a single-group, non-masked study with allocation listed as not applicable. Its phase field identifies Phase 1, while the official title describes the study as Phase Ib/II. These are both features of the registry record; the record does not provide additional explanation for the difference in wording. The study is titled ARRO-CITO and evaluates IONIS-AR-2.5Rx, also called ARRx, with enzalutamide in metastatic castration-resistant prostate cancer.
The arm description says participants received the combination. ARRx was administered intravenously on specified days in the first cycle and on specified days in subsequent 21-day cycles; enzalutamide was taken daily in 21-day cycles starting on day 1 of cycle 1. The registry text available for the regimen ends partway through its description, so details beyond the recorded text are not reported in the registry record.
The study began on 2019-05-31, reached primary completion on 2023-01-24, and has a terminated status. The registry lists enrollment as 9. Enrollment is not necessarily the same as the number contributing to a particular endpoint, and the record does not provide a complete endpoint analysis population.
Because there is no control group, the design does not offer a randomized comparison between the combination and another treatment. The dose-level safety summaries should not be read as if the levels were assigned in a randomized comparison: the registry explicitly notes that the arms are not a like-for-like control comparison. The reason for termination, the dose-escalation decision rules, the sample-size justification, and any interim-analysis plan are not reported in the registry record.
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: 600 mg IONIS | Dose Level 2: 750 mg IONIS | Dose Level 3: 900 mg IONIS |
|---|---|---|---|
| STARTED | 1 | 5 | 3 |
| COMPLETED | 1 | 2 | 0 |
| NOT COMPLETED | 0 | 3 | 3 |
Reasons for not completing this period:
| Reason | Dose Level 1: 600 mg IONIS | Dose Level 2: 750 mg IONIS | Dose Level 3: 900 mg IONIS |
|---|---|---|---|
| Death | 0 | 1 | 0 |
| Withdrawal by Subject | 0 | 1 | 1 |
| Sponsor Termination | 0 | 1 | 0 |
| Adverse Event | 0 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
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: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
| Characteristic | Unit | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|---|
| Participants analysed | 1 | 5 | 3 | 9 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 4 | 2 | 6 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 0 | 5 | 3 | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 5 | 3 | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 0 | 4 | 2 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | — | 5 | 3 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Subjects With Dose-limiting Toxicity (DLT) During the First Cycle of ARRx (in Combination With Enzalutamide), measured over Up to day 21 of treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with dose-limiting toxicity during the first cycle of ARRx in combination with enzalutamide, assessed up to day 21 of treatment. It is a count of participants meeting the toxicity definition, rather than a measure of average symptom severity or a comparison of treatment effects. The registry says that a participant cannot trigger more than one dose-limiting toxicity event for this endpoint.
The definition uses a Grade 3 or higher toxicity under CTCAE v5.0, while excluding toxicity clearly and directly related to the primary disease or to another etiology. This rule is intended to focus the endpoint on qualifying treatment-period toxicities rather than every adverse health event. As a general statistical concept, an early-cycle dose-limiting toxicity endpoint can help characterize tolerability at a dose level during treatment initiation. It does not, on its own, describe longer-term safety or establish how outcomes compare with another regimen.
The registry states that a single participant was included in the Dose Level 1 arm and that the primary data are not reported publicly to protect participant confidentiality. It therefore does not give a publicly interpretable primary endpoint count or estimate. Further details about endpoint assessment procedures and the analysis population are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The public record does not provide the primary endpoint result. Although it identifies the endpoint, its definition, and the timeframe, it says that the Dose Level 1 data are not reported publicly because a single participant was included at that dose level and confidentiality must be protected. The number of participants with dose-limiting toxicity at that level therefore cannot be read from the record. No primary-endpoint estimate, confidence interval, or statistical test is reported.
Safety summaries are available for Level 1, Level 2, and Level 3. For Level 1, the registry lists 1 participant at risk for serious adverse events and 0 affected; it lists 0 at risk and 0 affected for other adverse events, with 0 deaths. For Level 2, it lists 5 at risk and 2 affected for serious adverse events, 5 at risk and 5 affected for other adverse events, and 1 death. For Level 3, it lists 3 at risk and 1 affected for serious adverse events, 3 at risk and 3 affected for other adverse events, and 0 deaths. These are descriptive counts, not results from a randomized comparison.
The listed serious-event terms include Thromboembolic Event at 33.3%, and Back Pain, Acute Kidney Injury, Sepsis, and Fever at 20.0% each. The record does not specify the denominator or further details for each term in this summary, so the percentages should be interpreted as registry-reported figures rather than recalculated estimates. They do not replace the primary endpoint, which has a distinct definition and timeframe.
In general, small descriptive safety summaries can identify events recorded during a study, but they provide limited precision about how frequently events would occur in a broader population. The registry does not provide confidence intervals or comparative estimates for these safety figures. The termination status also does not, by itself, indicate why the study ended or what conclusion should be drawn about the combination. The reason for termination is not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is a binary participant-level event summarized as a count: each participant either meets the dose-limiting toxicity definition during the stated period or does not. The registry specifies that no single participant can trigger more than one dose-limiting toxicity event for this endpoint. This avoids treating multiple qualifying toxicities in one participant as multiple participants when the outcome is explicitly framed as a participant count.
What can a count establish?
A count describes the number of observed participants meeting the endpoint in the population assessed. To understand how frequent an event was, readers generally also need a clearly defined denominator and a specified analysis population. A proportion can then be estimated, and uncertainty can be expressed with a confidence interval. These are general statistical principles. In this record, the primary count is not publicly reported for Dose Level 1, and there is no publicly reported primary-endpoint estimate or interval to interpret.
Why is the first-cycle window important?
The endpoint is limited to up to day 21 of treatment. A fixed observation window makes clear which period contributes to the count and can focus attention on early treatment tolerability. It does not describe events outside that window. In general, a result for an early-cycle endpoint should not be taken as a complete account of later safety, treatment duration, or other clinical outcomes. The registry separately lists outcomes such as PSA reduction, one-year overall survival, dose delays, and dose reductions, but it reports no analyses for them in the record.
Why not compare the dose levels as if randomized?
The study is single-group, and allocation is listed as not applicable. The record cautions that the arms are not a like-for-like control comparison. In general, randomized comparisons use assignment procedures to make treatment groups comparable, on average, for both measured and unmeasured factors. Without such a design, differences between groups may reflect who entered each dose level, how treatment proceeded, or other factors, rather than dose alone. The registry does not report enough information to assess those possibilities. The dose-level counts are therefore best treated as descriptions of the posted safety data.
How should uncertainty be understood?
A confidence interval is a range of values compatible with the data under a statistical model and communicates the precision of an estimate. Sparse counts usually yield substantial uncertainty, but no interval for the primary endpoint is publicly reported. An absent interval is not evidence that an estimate is precise; it means the record does not supply that uncertainty measure. No primary statistical test or p-value is reported either.
For count outcomes, a statistical model may sometimes account for over-dispersion, meaning variability greater than the model expects. That issue matters when counts vary more widely than a simple model assumes. It is a general consideration, not a claim about this trial: the primary outcome is reported as a count of participants with an event, and the registry does not report a model or an over-dispersion assessment for it.
The record's sample-size planning assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event outcomes, the illustration is expressed as a total number of events; for other outcomes, it is expressed as participants per arm. These assumptions describe planning calculations, not observed trial results, and they are not the trial's own design justification. The registry does not report the protocol's sample-size justification or enough primary endpoint information to assess a trial-specific effect estimate. Planning sample sizes must not be interpreted as observed power.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Level 2 | 5 | 0 | 0.0% | 0.0% to 52.2% | 0.0% to 43.4% | 0.4% to 45.9% |
| Level 3 | 3 | 0 | 0.0% | 0.0% to 70.8% | 0.0% to 56.1% | 0.6% to 60.2% |
R code and output
arm <- c("Level 2", "Level 3")
n <- c(5, 3)
events <- c(0, 0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Level 2 5 0 0.0 0.0 52.2 0.0 43.4 0.4 45.9
ARM Level 3 3 0 0.0 0.0 70.8 0.0 56.1 0.6 60.211. Multiplicity, Missing Data and Analysis Populations
The registry lists 6 outcome measures and identifies several secondary outcomes, including PSA reduction, overall survival at one year, dose delays, and dose reductions. It reports 0 analyses. The record does not describe a statistical plan for handling multiple outcomes, multiple time points, or multiple dose levels. In general, testing many hypotheses can increase the chance of at least one apparently notable result by chance; methods for controlling that risk should be specified in an analysis plan. No such method is reported in the registry record, so the extent to which multiplicity was addressed cannot be assessed.
The record also does not provide a complete account of missing outcome data, reasons for missingness, or methods used to handle missing observations. The primary endpoint data for the single participant in Dose Level 1 are explicitly not reported publicly for confidentiality. That is a reporting limitation; it should not be recast as a known clinical outcome or as evidence that the endpoint was not assessed. The record does not explain whether other endpoint results were unavailable, uncollected, or withheld.
Details of analysis populations are also limited. Enrollment is listed as 9, but that figure alone does not establish how many participants were eligible, treated, evaluable for each endpoint, or included in a particular analysis. The registry does not report those endpoint-specific populations in the information available. As a general principle, analysis populations should be defined clearly because the participants included can affect interpretation. Without those definitions, the relationship between enrollment and each posted outcome cannot be fully evaluated.
Randomization is not applicable in this single-group study, and no comparative analysis plan is reported. The record does not report an interim-analysis plan, missing-data assumptions, or a prespecified approach to multiplicity. These omissions limit assessment of how analyses were selected and how robust the reported summaries are.
12. 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 |
|---|---|---|---|
| Level 1 | 0 | 1 | 0.0% |
| Level 2 | 2 | 5 | 40.0% |
| Level 3 | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Level 1 | 0 of 0 |
| Level 2 | 1 of 5 |
| Level 3 | 0 of 3 |
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 |
|---|---|
| Level 1 | 0 of 0 |
| Level 2 | 5 of 5 |
| Level 3 | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Thromboembolic Event | Vascular disorders | 0 of 1 | 1 of 5 | 1 of 3 |
| Back Pain | Musculoskeletal and connective tissue disorders | 0 of 1 | 1 of 5 | 0 of 3 |
| Acute Kidney Injury | Renal and urinary disorders | 0 of 1 | 1 of 5 | 0 of 3 |
| Sepsis | General disorders | 0 of 1 | 1 of 5 | 0 of 3 |
| Fever | General disorders | 0 of 1 | 1 of 5 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | 0 of 0 | 2 of 5 | 3 of 3 |
| Aspartate aminotransferase increased | Investigations | 0 of 0 | 2 of 5 | 3 of 3 |
| Fatigue | General disorders | 0 of 0 | 3 of 5 | 2 of 3 |
| Diarrhea | Gastrointestinal disorders | 0 of 0 | 2 of 5 | 2 of 3 |
| Pain | General disorders | 0 of 0 | 0 of 5 | 3 of 3 |
| Dizziness | Nervous system disorders | 0 of 0 | 1 of 5 | 1 of 3 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 0 of 0 | 1 of 5 | 1 of 3 |
| Headache | Nervous system disorders | 0 of 0 | 2 of 5 | 0 of 3 |
| Nausea | Gastrointestinal disorders | 0 of 0 | 1 of 5 | 1 of 3 |
| Vomiting | Gastrointestinal disorders | 0 of 0 | 0 of 5 | 2 of 3 |
Serious events with the highest arm-level rate: thromboembolic event (33.3%), back pain (20.0%), acute kidney injury (20.0%), sepsis (20.0%), fever (20.0%).
The registry reports safety counts by Level 1, Level 2, and Level 3. For serious adverse events, the listed at-risk and affected counts are 1 and 0 for Level 1, 5 and 2 for Level 2, and 3 and 1 for Level 3. For other adverse events, the listed counts are 0 and 0 for Level 1, 5 and 5 for Level 2, and 3 and 3 for Level 3. Deaths are listed as 0, 1, and 0, respectively. These are separate descriptive categories; the record does not explain their overlap or provide a narrative account for each event.
The serious-event terms listed with percentages are Thromboembolic Event at 33.3%, Back Pain at 20.0%, Acute Kidney Injury at 20.0%, Sepsis at 20.0%, and Fever at 20.0%. The registry summary does not state the denominator or provide event-level context for these percentages. They should not be treated as comparable incidence estimates across dose levels, nor should they be used to infer causation. The small descriptive groups and lack of a control group limit comparisons. The reason for the recorded death is not reported in the registry record.
13. What the Result Does, and Does Not, Mean
The registry supports a limited descriptive account: it identifies the combination studied, defines an early dose-limiting toxicity endpoint, reports safety counts by dose level, and lists several serious adverse-event terms with percentages. It also records enrollment as 9 and study status as terminated. These registry entries describe what the registry reports; they do not establish a treatment effect.
The primary endpoint result for Dose Level 1 is not publicly reported because a single participant was included in that arm and the data are withheld to protect confidentiality. Consequently, readers cannot evaluate the primary count at that level from the public record. The registry also reports 0 analyses, and no primary estimate, uncertainty interval, or hypothesis test is available. The secondary outcomes listed in the record do not have reported analyses in the material.
As a general principle, safety observations in a single-group study can describe events recorded among participants, but without a control group they cannot isolate the effect of the study combination from other explanations. The safety counts should not be read as proof that an event was caused by, or unrelated to, treatment. Nor do the listed dose levels establish a dose-response relationship: the record does not describe randomized assignment or a like-for-like comparison across levels.
The figures also do not establish how well the combination performs relative to another treatment, or whether it changes outcomes outside the recorded safety summaries. Such conclusions would require appropriate outcome data and a design and analysis suited to the question. The registry does not report the reason for termination, a sample-size justification, or a full statistical analysis plan. Those omissions prevent a fuller assessment of why the study ended and how its results were intended to support conclusions.
14. Why This Trial Matters Statistically
This record illustrates why a trial's design and public reporting both matter when interpreting clinical statistics. A defined endpoint can be understood only alongside its population, observation window, event criteria, and available results. Here, the endpoint is clearly framed as a count of participants with a qualifying dose-limiting toxicity during the first cycle, but the primary data for Dose Level 1 are not publicly reported.
It also demonstrates the distinction between descriptive safety summaries and comparative evidence. Counts by dose level can document what the registry records, but this study is single-group, allocation is not applicable, and the record cautions that the levels are not like-for-like control groups. Treating those summaries as a randomized comparison would overstate what the design can establish.
Uncertainty and transparency are central to statistical interpretation. The public record does not provide a primary estimate, confidence interval, or analysis, and it reports 0 analyses. It does not explain the reason for termination, the protocol's sample-size justification, or an analysis plan for multiple outcomes. Readers therefore need to distinguish what is explicitly reported from questions the registry cannot answer.
Finally, confidentiality can constrain public reporting, particularly where a dose-level population is very small. The record explains that the primary endpoint data are withheld for that reason. This limits external assessment even though the endpoint definition is present. The example highlights the value of clear reporting about populations, missing information, and analytic methods, alongside careful respect for participant confidentiality.
15. 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 primary endpoint data for Dose Level 1 are not publicly reported. The registry states that a single participant was included in that arm and cites confidentiality. Without the count, an estimate, or uncertainty information, the endpoint cannot be quantitatively interpreted from the public record.
The study has no separate control group and is not described as randomized. The registry explicitly warns that the dose-level groups are not a like-for-like control comparison. Consequently, the safety summaries cannot support a controlled comparison between levels, and the record does not provide a basis for attributing observed events to treatment.
Although enrollment is listed as 9, endpoint-specific analysis populations and participant flow are not reported in the record. The available regimen description is truncated. The record also does not report the reason for termination, the protocol's sample-size justification, a statistical analysis plan, interim analyses, or methods for handling missing data and multiplicity. It lists 0 analyses, leaving no reported primary statistical estimate or test to evaluate.
The serious-event percentages are reported without a stated denominator or further event-level context in the summary. The safety counts and percentages therefore have limited interpretability, particularly for comparisons. The registry status of terminated does not explain whether termination was administrative, operational, safety-related, or due to another reason; the reason is not reported in the registry record. These limitations should be considered alongside the descriptive information that is available.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer — NCT03300505.
- Registry record last updated 2025-05-13; status last verified 2025-05.
- Results first posted 2025-05-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
The registry record describes NCT03300505, a single-group study of ARRx with enzalutamide in metastatic castration-resistant prostate cancer. Its phase field lists Phase 1, while the official title describes Phase Ib/II. Allocation is not applicable, masking is none, enrollment is 9, and the study status is terminated. The recorded start date is 2019-05-31, and primary completion is listed as 2023-01-24.
The primary endpoint counts participants with dose-limiting toxicity during the first cycle, up to day 21. The registry states that the Dose Level 1 data are not reported publicly to protect confidentiality. Safety summaries are listed for Level 1, Level 2, and Level 3, and several serious-event terms have associated percentages. The registry lists 6 outcome measures and reports 0 analyses. It does not report the reason for termination or a full statistical analysis plan.