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 Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC (NCT00327340), a randomized phase 2 study. The primary outcome is Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00327340 |
| Phase | Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 70 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Achieve Life Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients with prostate cancer that had spread beyond the prostate. The brief summary describes participants as previously treated with docetaxel, with or without prednisone, whose cancer either did not respond or later progressed. The primary-outcome description identifies a total analysis population of 69 subjects. It also states that 70 subjects were enrolled, 45 were randomly assigned, and an additional 25 were assigned to the docetaxel combination.
Intervention
Both treatment combinations included custirsen, also called OGX-011, with prednisone. One combined custirsen with mitoxantrone; the other combined custirsen with docetaxel. The registry describes these as second-line chemotherapy combinations.
Comparator
The comparison is between the two custirsen-containing chemotherapy combinations: mitoxantrone/prednisone and docetaxel/prednisone. The record does not describe a group receiving chemotherapy without custirsen or a group receiving no study treatment.
Primary question
The primary outcome concerns the safety and tolerability of custirsen when combined with either chemotherapy regimen. Adverse events and serious adverse events were graded using CTCAE. The registry does not give a single numerical result or a direct statistical comparison between the combinations for this primary outcome.
3. Trial Design
This was a phase 2, randomized, parallel-group study with no masking. Its title describes a pilot study evaluating the safety and feasibility of custirsen in combination with second-line chemotherapy for hormone-refractory prostate cancer. The registry lists prostate cancer as the condition and Achieve Life Sciences as the sponsor. The study began in 2006-07, had primary completion in 2010-10, and is recorded as completed.
The intended treatment combinations were custirsen with mitoxantrone and prednisone, or custirsen with docetaxel and prednisone. The record describes 45 participants as randomly assigned: 24 to the mitoxantrone combination and 21 to the docetaxel combination. It also reports an additional 25 participants assigned to the docetaxel combination. The primary-outcome description gives a total analysis population of 69 subjects. One subject in the mitoxantrone arm is described as ineligible; further details about that participant’s disposition are not reported in the registry record.
The primary safety follow-up was described as extending from enrollment for up to 8 months, covering 9 three-week cycles plus 30 days after the end of treatment. The record lists PSA response, time to pain progression, and the relationship between changes in serum clusterin and PSA as secondary outcomes. It does not give enough detail to establish how the randomized assignment, the additional docetaxel assignments, or the analysis population were handled in each outcome analysis.
Randomization can help balance participant characteristics across groups, but its interpretation depends on how assignment and subsequent analysis were carried out. Here, the record identifies randomized assignment for some participants and additional assignment to one regimen, without a full account of the allocation process. The study is unmasked, so participants and study personnel were not described as blinded. Further details of the protocol and 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.
Before assignment: A total of 70 subjects were enrolled. 45 subjects were randomly assigned to treatment (21 to OGX-011/ docetaxel and 24 OGX-011/ mitoxantrone). An additional 25 subjects were enrolled under Amendment 2 and assigned to OGX-011/docetaxel retreatment. One subject was found to be ineligible and was not treated.
Overall Study
| Stage | OGX-011 / Mitoxantrone/Prednisone | OGX-011 / Docetaxel/Prednisone |
|---|---|---|
| STARTED | 23 | 46 |
| COMPLETED | 8 | 16 |
| NOT COMPLETED | 15 | 30 |
Reasons for not completing this period:
| Reason | OGX-011 / Mitoxantrone/Prednisone | OGX-011 / Docetaxel/Prednisone |
|---|---|---|
| Withdrawal by Subject | 1 | 5 |
| Physician Decision | 1 | 1 |
| Disease Progression | 10 | 19 |
| Symptomatic Disease | 0 | 2 |
| Adverse Event | 3 | 3 |
Analysis population for the primary outcome, as defined in the registry: The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.
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 | OGX-011 / Mitoxantrone/Prednisone | OGX-011 / Docetaxel/Prednisone | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 46 | 69 | |
| Age Continuous | years | 61 (49 to 81) | 64 (48 to 80) | 63 (48 to 81) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 23 | 46 | 69 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): White | Participants | 21 | 42 | 63 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Karnofsky Score: 60-70% | participants | 2 | 6 | 8 |
| Karnofsky Score: 80% | participants | 7 | 13 | 20 |
| Karnofsky Score: 90% | participants | 7 | 22 | 29 |
| Karnofsky Score: 100% | participants | 7 | 5 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy., measured over Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is safety and tolerability of custirsen combined with either docetaxel/prednisone or mitoxantrone/prednisone as second-line chemotherapy. It is expressed as the percentage of participants, and its description says safety was assessed through adverse events and serious adverse events graded with the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). The record explains the general severity scale: Grade 1 is mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening or disabling, and Grade 5 death related to an adverse event.
A safety endpoint is used to characterize unwanted events during treatment and follow-up, including their severity. General statistical context: reporting the number or percentage of participants with events helps describe how often events occurred in the observed study population. It does not, by itself, establish that a treatment caused an event or determine how two regimens compare. Those interpretations depend on the event definitions, the periods at risk, participant follow-up, and the analysis method.
The registry gives serious and other adverse-event counts by treatment group, but it does not provide one overall primary-outcome estimate or a defined statistical comparison for the primary endpoint. The primary-outcome results across its categories or time points are not reduced to a single comparison in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that this completed phase 2 study examined custirsen in combination with two second-line chemotherapy regimens. It records safety and tolerability as the primary outcome and describes adverse events and serious adverse events graded with CTCAE. It does not report a single overall primary-outcome result or a statistical test comparing the regimens for that outcome. Consequently, the record does not support a concise estimate of the relative safety of the two combinations from the primary endpoint.
For serious adverse events, the mitoxantrone/prednisone group lists 23 participants at risk and 6 affected. The docetaxel/prednisone group lists 46 at risk and 12 affected. These are group-specific counts. They should not be treated as a formal comparison: the record does not report a confidence interval, p-value, adjustment, or analysis method for comparing those figures. The groups also have different reported numbers at risk, so the counts alone do not express a standardized contrast.
For other adverse events, the record lists 23 at risk and 23 affected in the mitoxantrone/prednisone group, and 46 at risk and 46 affected in the docetaxel/prednisone group. These counts describe the posted results, but do not clarify how events were counted when a participant experienced more than one event, or how event severity and timing contributed to the primary outcome. Such details are not reported in the registry record.
The registry lists six serious adverse-event terms among its most frequent terms, each reported as 4.3%: Septic Shock, Asthenia, Febrile Neutropenia, Cardiac Failure, Dehydration, and Prostate Cancer Metastatic. The record does not provide enough accompanying detail to interpret these term percentages as a treatment-group contrast, establish whether they count participants or events, or determine the relevant denominator. These terms therefore should be read as descriptive entries, not as comparative estimates.
Precision cannot be evaluated for the primary safety outcome from a single estimate because no such estimate or interval is reported. General statistical context: a confidence interval communicates the range of values reasonably compatible with data and a specified analysis; without one, readers cannot assess uncertainty around a comparative estimate. The absence of a reported comparison is not evidence that the regimens were equivalent, nor does it establish that either regimen had fewer or less severe events.
The trial’s pilot framing and safety focus are important when reading the registry. The available information describes participants, treatment combinations, follow-up, and selected event counts. It does not report a treatment-effect estimate for survival, tumor response, or another clinical efficacy outcome as the primary result. The listed secondary outcomes concern PSA response, pain progression, and serum clusterin and PSA changes, but their numerical findings are not reported in the registry record.
9. Statistical Methods Explained
Interpretation of a clinical trial depends on how participants were assigned, what was measured, how outcomes were summarized, and how uncertainty was quantified. The registry identifies this study as randomized, unmasked, and parallel-group. It does not report a detailed statistical analysis plan, including the specific models, tests, or adjustment procedures used for the outcomes. The discussion below explains general concepts relevant to the recorded design; it does not assert that a particular method was used in this trial.
What does randomization contribute?
In general, random assignment aims to make treatment groups comparable at the start of a study, including for factors that were not measured. This can support a fair comparison when assignment is maintained and participants are analyzed in a way consistent with the trial question. Here, the record reports 45 randomly assigned participants and separately describes an additional 25 participants assigned to the docetaxel combination. It does not explain the process for that additional assignment or give a full account of how these participants were incorporated into each analysis. Therefore, the randomized label alone does not establish that every reported group comparison has the properties of a randomized comparison.
What does an unmasked design mean?
In an unmasked study, participants and study personnel are not described as unaware of treatment assignment. General statistical context: knowledge of assignment can influence subjective reporting, clinical management, or judgments about whether an event occurred. Objective definitions and consistent assessment can reduce some concerns, but the record does not give enough detail about event ascertainment to assess those safeguards. CTCAE grading provides a named framework for severity, but it does not by itself show how consistently events were identified or graded.
How should percentages and counts be read?
A percentage of participants with an event is a binary summary: each participant is classified according to whether the specified event occurred during the defined period. This can be useful for describing incidence, but it compresses information. It may not distinguish one event from repeated events in the same participant, and it may not convey event timing, duration, or severity unless these are reported separately. General statistical context: comparisons of binary outcomes can be expressed in several ways, each with its own interpretation and uncertainty. The registry does not report a comparative estimate for the primary endpoint, so no such measure should be inferred from the counts.
The numbers at risk matter because an event count is interpretable only in relation to the population and follow-up used to generate it. The registry records 23 at risk in the mitoxantrone/prednisone group and 46 at risk in the docetaxel/prednisone group for both serious and other adverse events. It does not explain the detailed relationship between these safety denominators and the enrollment, randomization, and total analysis population figures. Nor does it specify whether all participants had the same duration of observation. The stated safety follow-up was from enrollment for up to 8 months, but the record does not give participant-level follow-up details.
Why does uncertainty matter?
General statistical context: an estimate from a sample is subject to sampling variability. A confidence interval describes uncertainty around an estimate under a particular model and assumptions. A p-value, when reported, addresses compatibility of the observed data with a specified null hypothesis; it does not measure the size or clinical importance of an effect. Neither a confidence interval nor a p-value is reported for a primary-outcome comparison in the registry record. Without those quantities and a clear estimand, the precision and evidential strength of a direct comparison cannot be assessed.
What is over-dispersion, and is it relevant?
General statistical context: over-dispersion occurs when count data vary more than a simple statistical model expects. It can make standard errors too small if a model assumes less variability than the data contain. It is most relevant to analyses of counts or rates, especially when repeated events are possible. The primary endpoint is described as a percentage of participants with an event, and no count-model analysis is reported. The registry does not report whether recurrent events were analyzed or whether over-dispersion was assessed, so this issue cannot be attributed to the trial’s analysis.
How should planning calculations be distinguished from trial results?
General statistical context: a sample-size planning calculation asks how many participants might be needed under chosen assumptions about the effect, variability, allocation, and error rates. It is a planning illustration, not a result observed in a trial and not a measure of the probability that the trial found a true effect. The registry record does not report a sample-size justification or the assumptions used in the original design. It also does not provide a single primary-outcome effect from which a planning illustration could be interpreted as a comparison. Any planning values should therefore be kept distinct from the observed participant and event counts.
The study is described as a pilot study focused on safety and feasibility. That description gives context for its purpose but does not establish a particular target sample size, stopping rule, or interim analysis. Those details are not reported in the registry record. Likewise, the record does not report whether analyses were adjusted for baseline factors, how missing outcomes were handled, or whether any multiplicity procedure was used. These omissions constrain interpretation rather than demonstrating that a method was or was not used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists safety and tolerability as the primary outcome and also names secondary outcomes concerning PSA response, time to pain progression, and the relationship between changes in serum clusterin and PSA. With several outcomes, time points, or event categories, the chance of at least one apparently notable result can increase if many statistical tests are conducted. General statistical context: multiplicity procedures can control this issue, but the appropriate approach depends on which outcomes were treated as confirmatory and how the analyses were planned. A multiplicity strategy is not reported in the registry record.
The record identifies four outcome measures and lists no analyses. It does not report a statistical analysis plan, the number of comparisons actually performed, any hierarchy among outcomes, or whether analyses were adjusted for multiple testing. Therefore, readers cannot determine from the registry record how multiplicity was addressed or how much weight to give any individual result.
Missing-data methods are also not reported in the registry record. The primary-outcome description states that 70 subjects were enrolled and that the total analysis population was 69. It reports 45 randomized participants, including 24 assigned to the mitoxantrone combination and 21 to the docetaxel combination, plus an additional 25 assigned to the docetaxel combination. One participant in the mitoxantrone arm is identified as ineligible. The record does not provide a complete participant flow or explain how eligibility, withdrawal, incomplete follow-up, or missing outcome assessments were handled.
These details matter because analysis populations can answer different questions. General statistical context: analyzing participants according to randomized assignment can preserve the benefits of randomization, while analyses restricted to participants who received or completed treatment may describe a different population and can introduce bias. The registry record does not identify which analysis population was used for each outcome or provide enough detail to determine how the reported safety counts relate to the randomized groups.
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 |
|---|---|---|---|
| OGX-011 / Mitoxantrone/Prednisone | 6 | 23 | 26.1% |
| OGX-011 / Docetaxel/Prednisone | 12 | 46 | 26.1% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| OGX-011 / Mitoxantrone/Prednisone | 23 of 23 |
| OGX-011 / Docetaxel/Prednisone | 46 of 46 |
Most frequent serious adverse event terms
| Event term | Organ system | OGX-011 / Mitoxantrone/Prednisone | OGX-011 / Docetaxel/Prednisone |
|---|---|---|---|
| Asthenia | General disorders | 1 of 23 | 1 of 46 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 1 of 23 | 1 of 46 |
| Dehydration | Metabolism and nutrition disorders | 1 of 23 | 1 of 46 |
| Bronchiolitis | Infections and infestations | 0 of 23 | 1 of 46 |
| Klebsiella Sepsis | Infections and infestations | 0 of 23 | 1 of 46 |
| Pneumonia | Infections and infestations | 0 of 23 | 1 of 46 |
| Upper Respiratory Tract Infection | Infections and infestations | 0 of 23 | 1 of 46 |
| Urinary Tract Infection | Infections and infestations | 0 of 23 | 1 of 46 |
| Septic Shock | Infections and infestations | 1 of 23 | 0 of 46 |
| Acute Abdomen | Gastrointestinal disorders | 0 of 23 | 1 of 46 |
Most frequent non-serious adverse event terms
| Event term | Organ system | OGX-011 / Mitoxantrone/Prednisone | OGX-011 / Docetaxel/Prednisone |
|---|---|---|---|
| Fatigue | General disorders | 18 of 23 | 32 of 46 |
| Nausea | Gastrointestinal disorders | 14 of 23 | 23 of 46 |
| Oedema Peripheral | General disorders | 10 of 23 | 21 of 46 |
| Chills | General disorders | 10 of 23 | 19 of 46 |
| Pyrexia | General disorders | 14 of 23 | 14 of 46 |
| Decreased Appetite | Metabolism and nutrition disorders | 12 of 23 | 16 of 46 |
| Vomiting | Gastrointestinal disorders | 10 of 23 | 16 of 46 |
| Diarrhoea | Gastrointestinal disorders | 5 of 23 | 19 of 46 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 5 of 23 | 12 of 46 |
| Cough | Respiratory, thoracic and mediastinal disorders | 6 of 23 | 11 of 46 |
Serious events with the highest arm-level rate: septic shock (4.3%), asthenia (4.3%), febrile neutropenia (4.3%), cardiac failure (4.3%), dehydration (4.3%).
The serious adverse-event figures are descriptive counts. The registry lists 23 participants at risk and 6 affected in the OGX-011 / Mitoxantrone/Prednisone group, and 46 at risk and 12 affected in the OGX-011 / Docetaxel/Prednisone group. The counts should be kept alongside their respective group labels and denominators; they are not, by themselves, a statistical comparison between regimens.
The record also lists the following serious adverse-event terms at 4.3% each: Septic Shock, Asthenia, Febrile Neutropenia, Cardiac Failure, Dehydration, and Prostate Cancer Metastatic. It does not report the group-specific counts for these terms, define the denominator for the percentages, or clarify whether the percentages refer to participants or events. The term list therefore does not establish which regimen had more of any particular event.
General statistical context: adverse-event summaries depend on definitions, observation time, and whether repeated events are counted once per participant or separately. A raw count does not account for uncertainty, differences in exposure time, or differences in participant characteristics. The registry provides a safety follow-up period of up to 8 months from enrollment, but does not report detailed follow-up by participant. No comparative interval or test for serious adverse events is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed phase 2 pilot study of custirsen with either docetaxel/prednisone or mitoxantrone/prednisone in patients with hormone-refractory prostate cancer. It gives a primary safety and tolerability outcome based on adverse events and serious adverse events, and it reports group-specific participant counts for these event categories. This information can be used to understand what the study set out to examine and to identify the event counts recorded for each group.
It does not establish a statistically supported difference between the two chemotherapy combinations. No single primary-outcome comparison, confidence interval, or p-value is reported in the registry record. The event counts should not be converted into an informal claim that one regimen is safer, because the record does not supply the comparative analysis, its uncertainty, or enough detail about the analysis populations and follow-up.
The results also do not establish equivalence. A failure to report a comparison is not evidence that the groups had the same safety experience. Likewise, the presence of serious adverse events in the registry does not, on its own, show that a study drug caused those events. Causal interpretation would require a clearly defined comparison and consideration of participants’ underlying illness, concomitant treatment, follow-up, and event assessment.
The study’s secondary outcomes refer to PSA response, time to pain progression, and changes in serum clusterin in relation to PSA changes. Their numerical results are not reported in the registry record. The available information therefore does not provide a basis for drawing conclusions about those outcomes or about treatment efficacy. In general, a statistical result describes the data and analysis used; its meaning depends on outcome definitions, participant selection, missingness, and uncertainty. Those elements are incompletely reported for this trial.
The appropriate reading is limited but useful: the record documents a clinical study design and selected safety summaries, while leaving key comparative and analytic details unavailable. It is not a complete account of the protocol or results, and it should not be treated as a substitute for a fully reported analysis.
13. Why This Trial Matters Statistically
This trial is statistically informative because it illustrates how the design description and the reported analysis population can require careful reading together. The record calls the study randomized, but reports 45 randomized participants and an additional 25 participants assigned to the docetaxel combination. The total analysis population is stated as 69. Without a complete account of assignment and participant flow, readers cannot assume that every reported group summary represents a straightforward comparison of randomized groups.
The primary outcome is safety and tolerability, a broad outcome involving adverse events and serious adverse events graded by severity. Broad safety outcomes can contain many event types and categories. General statistical context: a clear analysis plan helps readers understand which event definitions, follow-up periods, and comparisons were prespecified, and how uncertainty and multiplicity were handled. Those details are not reported in the registry record.
The record also shows why counts need their denominators and analysis context. Serious adverse events are summarized for groups with different numbers at risk. Raw counts are useful descriptive information, but they do not replace a defined effect estimate with an uncertainty interval. The record’s list of serious adverse-event terms includes percentages but does not give enough detail to establish their denominators or group-specific meaning.
Finally, a pilot safety study should be distinguished from a definitive comparative efficacy analysis. The title and outcomes emphasize safety and feasibility, and the record lists secondary outcomes related to PSA, pain progression, and serum markers. The absence of numerical findings for those outcomes means they cannot be interpreted from this record. More generally, a registry entry can document important trial features while still leaving the analysis plan, missing-data handling, and comparative estimates unavailable. Recognizing those gaps is part of sound statistical interpretation, not a judgment about the study’s conduct.
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 endpoint is described as a percentage of participants, but the registry does not report one overall primary-outcome estimate or a statistical comparison between the treatment combinations. Its description encompasses adverse events and serious adverse events, while the result summaries are presented as multiple categories. The record itself notes that the primary outcome has several categories or time points and is not reduced to one comparison. This limits direct interpretation of the study’s primary question.
Participant disposition is not fully described. The record reports 70 enrolled, a total analysis population of 69, 45 randomly assigned, and an additional 25 assigned to the docetaxel combination. It identifies one ineligible participant in the mitoxantrone arm, but the reason for ineligibility and subsequent handling are not reported in the registry record. The relationship between these enrollment, assignment, and analysis figures is therefore not fully clear.
The registry does not report detailed eligibility criteria, baseline characteristics, the allocation procedure, the statistical analysis plan, missing-data methods, or whether comparisons were adjusted. It also does not provide group-specific follow-up details or clarify how recurrent adverse events contributed to the summaries. The listed serious adverse-event term percentages lack enough information to establish their denominators and treatment-group distribution.
Although secondary outcomes are named, their numerical results are not reported in the registry record. The record does not provide a sample-size justification, interim-analysis information, or multiplicity strategy. These are reporting limitations: they prevent readers from evaluating aspects of design and analysis, but do not establish what procedures were or were not used during the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC — NCT00327340.
- Registry record last updated 2012-10-05; status last verified 2012-10.
- Results first posted 2012-08-29.
- 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
NCT00327340 is a completed phase 2, randomized, unmasked, parallel-group pilot study sponsored by Achieve Life Sciences. It began in 2006-07 and reached primary completion in 2010-10. The study evaluated custirsen (OGX-011) with either mitoxantrone/prednisone or docetaxel/prednisone as second-line chemotherapy for hormone-refractory prostate cancer.
The primary outcome concerns safety and tolerability, assessed through adverse events and serious adverse events graded using CTCAE. The record reports 70 enrolled subjects and a total analysis population of 69, along with randomized and additional treatment assignments. It gives serious and other adverse-event counts by group and lists six serious adverse-event terms at 4.3% each.
A single primary-outcome comparison, its uncertainty, and the numerical findings for the named secondary outcomes are not reported in the registry record. Details of the statistical plan, missing-data handling, and multiplicity procedures are also not reported.