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 Tivantinib in Treating Patients With Metastatic Prostate Cancer (NCT01519414), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS) Based on the RECIST Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01519414 |
| Phase | Phase 2 |
| Condition | Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 78 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The registry record lists hormone-resistant prostate cancer, prostate adenocarcinoma, recurrent prostate carcinoma and stage IV prostate cancer among the conditions studied. The total enrollment was 78.
Intervention
Patients in the tivantinib arm received tivantinib by mouth twice daily on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
Comparator
Patients in the placebo arm received placebo by mouth twice daily on days 1-28, with courses repeating every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression could cross over to the tivantinib arm.
Primary question
How did progression-free survival, measured from study entry to documented progression and/or death, compare between the randomized tivantinib and placebo arms? The registry record describes a log-rank comparison of the progression-free survival distributions.
The trial was a randomized, double-blind, placebo-controlled phase II study. Its stated aim was to study how well tivantinib compared with placebo in treating metastatic prostate cancer. The registry record describes tivantinib as a drug that may stop tumor-cell growth by blocking some enzymes needed for cell growth; that description is a proposed rationale, not a result of the trial.
The primary outcome was progression-free survival based on RECIST criteria, assessed up to 6 months. The posted results give a median and 95% confidence interval for each original arm, along with a log-rank p-value. A median describes the point in the estimated survival distribution at which half the group has experienced the event; it does not describe every participant’s course or give an individual prognosis.
The registry record also describes a crossover from placebo to tivantinib after progression. This makes the original randomized comparison and the later crossover experience distinct: the crossover group is not another randomized placebo comparison. The record does not report details of how crossover data were handled in the primary analysis.
3. Trial Design
This was a randomized, double-blind, placebo-controlled phase II study with a crossover model. The registry record lists 78 participants enrolled. In the posted primary outcome results, 52 participants are included in the tivantinib arm and 26 in the placebo arm. A separate crossover group contains 12 participants. The registry record does not explain the relationship between the enrollment total and the analysis counts in greater detail.
The tivantinib and placebo regimens were given orally twice daily on days 1-28, with courses repeating every 28 days while there was no disease progression or unacceptable toxicity. Patients assigned to placebo could cross over to tivantinib after disease progression. The protocol’s detailed rules for that transition are not reported in the registry record.
Randomization is intended to create groups whose baseline characteristics are comparable on average, while double masking is intended to limit the influence of treatment knowledge on care and assessment. These are general features of trial design; the registry record does not provide enough detail to describe the randomization procedure, allocation concealment or masking procedures.
The primary outcome was progression-free survival based on RECIST criteria. The record defines its timeframe as study entry to documented progression and/or death, assessed up to 6 months. It describes Kaplan-Meier curves and log-rank tests for comparing the arms, with additional Cox proportional hazards analyses. The posted primary result includes medians with 95% confidence intervals and a log-rank p-value, but no hazard ratio is reported in the registry record.
The study began on 2012-01-11, reached primary completion on 2015-08-18 and is listed as completed. The record lists the National Cancer Institute (NCI) as sponsor. Details such as the sample-size justification, eligibility criteria beyond the population description, and the planned handling of participants who crossed over 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.
Pre Cross-over
| Stage | Arm I (Tivantinib) | Arm II (Placebo) | Crossover From Placebo to Tivantinib |
|---|---|---|---|
| STARTED | 52 | 26 | 0 |
| COMPLETED | 52 | 26 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Post Cross-over
| Stage | Arm I (Tivantinib) | Arm II (Placebo) | Crossover From Placebo to Tivantinib |
|---|---|---|---|
| STARTED | 52 | 14 | 12 |
| COMPLETED | 52 | 14 | 12 |
| NOT COMPLETED | 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.
| Characteristic | Unit | Arm I (Tivantinib) | Arm II (Placebo) | Total |
|---|---|---|---|---|
| Participants analysed | 52 | 26 | 78 | |
| Age, Continuous | years | 67 (43 to 84) | 66.5 (48 to 85) | 67 (43 to 85) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 52 | 26 | 78 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 6 | 8 |
| Race (NIH/OMB): White | Participants | 49 | 20 | 69 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | patients | 52 | 26 | 78 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS) Based on the RECIST Criteria, measured over Time from study entry to the date of documented progression and/or death, assessed up to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival (PFS) measures time from study entry until documented disease progression and/or death. In this trial, progression was based on RECIST criteria, and assessment was described as continuing up to 6 months. This endpoint combines two clinically important events into a time-to-event outcome: progression or death, whichever occurs first under the endpoint definition.
Time-to-event endpoints are useful when participants may experience the event at different times and when some may not have experienced it by the end of observation. General statistical explanation: Kaplan-Meier methods estimate the event-free distribution over time while accounting for participants whose follow-up ends before an event is recorded. A median is the time at which the estimated event-free distribution reaches its midpoint, when that midpoint can be estimated.
The posted medians are 5.5 months for tivantinib and 3.7 months for placebo. Their 95% confidence intervals are 3.2 to 8.0 months and 2.7 to 5.4 months, respectively. A confidence interval conveys uncertainty around an estimated quantity; it is not a range containing the outcome for every participant. The registry record reports a log-rank test to compare the complete PFS distributions, so the primary analysis is not simply a test of the two medians.
PFS does not describe symptoms, quality of life or every aspect of disease course. The registry record identifies other outcomes, including PSA-related measures and response, but those are distinct from the primary time-to-event endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results give median PFS of 5.5 months in the tivantinib arm and 3.7 months in the placebo arm. The corresponding 95% confidence intervals are 3.2 to 8.0 months and 2.7 to 5.4 months. These estimates describe the trial groups’ observed PFS distributions; they do not imply that every participant experienced progression or death at the median time.
The registry record reports a log-rank p-value of 0.02 for the comparison. This is evidence against the statistical null hypothesis of no difference between the PFS distributions, under the assumptions of the test. A p-value does not measure the size or clinical importance of an effect, and it is not the probability that the null hypothesis is true. It also does not establish that the observed difference will recur in another study.
The confidence intervals around the medians express uncertainty in each median estimate. Their overlap does not substitute for the log-rank comparison: the log-rank test uses event-time information across follow-up rather than comparing the two median estimates alone. No hazard ratio or confidence interval for a hazard ratio is reported in the registry record, so the relative instantaneous event rate cannot be described from the posted primary results.
Interpretation is also shaped by the trial’s size and structure. The posted PFS groups include 52 participants assigned to tivantinib and 26 assigned to placebo. The placebo arm could cross over after progression, and the record lists 12 participants in the crossover group. This means the post-progression experience is not simply an ongoing randomized comparison of the original assignments. The registry record does not report how the crossover was incorporated into analyses or how censoring and missing follow-up were handled.
The primary outcome is time to documented progression and/or death, assessed up to 6 months. The record does not report detailed results for each component separately, nor does it report the event counts or a full account of follow-up. Thus the posted medians and log-rank test characterize the primary endpoint as reported, but do not provide a complete account of the underlying event pattern.
The result is statistical evidence of a difference in the PFS distributions in this trial. It should be read alongside the uncertainty in the estimates, the phase II setting, the crossover design and the absence of a reported hazard ratio and analysis details. It does not by itself establish a treatment effect beyond the trial’s population and methods, and it is not medical advice.
9. Statistical Methods Explained
The registry record describes Kaplan-Meier estimation, a log-rank comparison and additional Cox proportional hazards analyses for PFS. Each method addresses time-to-event data, but they summarize different aspects of the event experience. The posted primary results give arm-specific medians and confidence intervals and report the log-rank p-value. They do not report a Cox-model estimate.
What does the Kaplan-Meier method estimate?
General statistical explanation: the Kaplan-Meier method estimates the probability of remaining free of the endpoint over follow-up. It updates that estimate at observed event times and accounts for participants who leave observation or reach the end of follow-up without a recorded event by censoring them at their last known time. Censoring is not the same as an event; it indicates that the participant’s later event status is not observed in the available follow-up.
The median PFS is read from the estimated survival curve at the point where the estimated event-free probability reaches its midpoint. It is a distribution summary, not an average and not a statement that all participants were followed for the same length of time. The record gives a 95% confidence interval for each arm’s median, communicating estimation uncertainty. The detailed number and timing of events, censoring patterns and method used to calculate the confidence intervals are not reported in the registry record.
What does the log-rank test compare?
General statistical explanation: the log-rank test compares the event-time distributions between groups across the observed follow-up. It uses information about when events occur and the group membership of participants at risk at those times. It is therefore not just a test of whether the two reported medians differ. Its usual interpretation relies on assumptions about how the groups and censoring operate over follow-up; detailed diagnostics or assumption checks are not reported in the registry record.
The posted log-rank p-value is 0.02. This quantifies how unusual data at least as incompatible with the null hypothesis would be under that hypothesis and the test’s assumptions. It is not an effect size or a probability that the null hypothesis is true. The registry record does not report the log-rank test statistic or a hazard ratio accompanying the test.
Why might a Cox model be used?
General statistical explanation: a Cox proportional hazards model can estimate a hazard ratio, comparing event rates between groups over follow-up, and can incorporate specified covariates. The proportional hazards assumption means the hazard ratio is treated as constant over time. The record says additional Cox analyses would be done, but no Cox estimate, covariate list, model diagnostics or adjusted result is reported in the registry record. It is therefore not possible to describe an adjusted hazard ratio from the posted results.
How should confidence intervals be read?
General statistical explanation: a confidence interval reflects uncertainty in an estimate under the method used to construct it. The 95% intervals for the medians are 3.2 to 8.0 months for tivantinib and 2.7 to 5.4 months for placebo. They show that the medians are estimated with uncertainty. They are not individual-level prediction intervals, and the interval for one arm should not be interpreted as a direct confidence interval for the difference between arms.
Because the outcome is a median time, a simple unadjusted recalculation of a between-arm effect from the posted summary statistics is not available. No recalculated PFS comparison is reported. The sponsor’s own log-rank analysis is therefore the reported inferential comparison for this endpoint.
What does crossover mean for interpretation?
General statistical explanation: when participants assigned to one group can receive the other intervention after a defined event, their later experience no longer represents continued exposure to their original assignment alone. An analysis based on initial randomization can retain the comparison of assignment strategies, while an analysis focused on treatment received after crossover asks a different question and may be affected by selection into crossover. The registry record gives a crossover group and says placebo participants with progression could cross over, but it does not report the primary analysis population, the handling of crossover or a separate adjusted crossover analysis.
The registry record’s described statistical approach names Kaplan-Meier, log-rank and Cox methods. Further details about analysis populations, missing data, censoring rules, stratification, covariate adjustment and planned sensitivity analyses are not reported in the registry record. These omissions limit the degree to which the posted result can be independently reconstructed from summary statistics.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | not reported | 0.020 |
The registry record reports the sponsor’s PFS comparison as a log-rank test with p = 0.02. The described analysis plan also names Kaplan-Meier estimation and additional Cox proportional hazards analyses. The posted results include median PFS and 95% confidence intervals by arm, but do not include a hazard ratio, its confidence interval or a Cox-model result.
A recalculated, unadjusted PFS comparison cannot be obtained from the posted medians and confidence intervals alone. Time-to-event comparisons depend on event timing and censoring information that is not contained in those summary values. Accordingly, there is no independent recalculated PFS estimate to set against the reported log-rank result. The sponsor’s own analysis takes precedence for the primary comparison, and no discrepancy is flagged in the registry record.
The log-rank p-value supports a statistical difference between the PFS distributions under that analysis; it does not quantify the magnitude of the difference or establish its clinical importance. The absence of a posted hazard ratio means the relative event-rate estimate cannot be interpreted from the registry results. Details such as the analysis population, handling of crossover and missing follow-up are not reported in the registry record, so those aspects of the sponsor analysis cannot be independently assessed from the posted information.
11. Multiplicity, Missing Data and Analysis Populations
The registry record identifies PFS as the primary outcome and lists several secondary outcomes, including PSA measures, response and adverse events. It also reports 8 outcome measures and 1 analysis. The registry record does not report a multiplicity adjustment strategy, an order of testing, or whether any secondary outcomes were intended to support formal confirmatory claims.
General statistical explanation: when multiple outcomes or comparisons are tested, the chance of observing at least one low p-value by chance can increase. Procedures such as adjusting significance thresholds or organizing tests hierarchically can address that issue, but they require a prespecified plan. Without a reported plan, unadjusted secondary comparisons are best treated as exploratory and interpreted with caution. The registry record reports no inferential analyses for the posted response outcomes.
Details about missing outcome data, loss to follow-up, censoring rules and analysis populations are not reported in the registry record. For PFS, those details matter because a participant without a documented progression or death may be censored, and the timing and reasons for censoring can affect the estimated curve. The record does not provide enough information to assess the amount or pattern of missing follow-up.
The crossover design adds an additional analysis issue. Participants initially assigned to placebo could receive tivantinib after progression, and a crossover group is listed in the posted results. The registry record does not explain whether the primary comparison followed initial assignment, how crossover affected follow-up or whether any analysis adjusted for crossover. These details are necessary to distinguish the effect of assignment from the effect of treatment received after progression.
The detailed randomization method, baseline balance, sample-size justification, interim analyses, sensitivity analyses and statistical analysis population are also not reported in the registry record. Their absence does not invalidate the posted figures, but it limits assessment of the assumptions behind them and the extent to which the analysis followed a fully specified plan.
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 |
|---|---|---|---|
| Arm I (Tivantinib) | 19 | 52 | 36.5% |
| Arm II (Placebo) | 22 | 26 | 84.6% |
| Crossover From Placebo to Tivantinib | 5 | 12 | 41.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I (Tivantinib) | 7 of 52 |
| Arm II (Placebo) | 4 of 26 |
| Crossover From Placebo to Tivantinib | 0 of 12 |
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 |
|---|---|
| Arm I (Tivantinib) | 52 of 52 |
| Arm II (Placebo) | 26 of 26 |
| Crossover From Placebo to Tivantinib | 12 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I (Tivantinib) | Arm II (Placebo) | Crossover From Placebo to Tivantinib |
|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | 1 of 52 | 2 of 26 | 0 of 12 |
| Death NOS | General disorders | 1 of 52 | 0 of 26 | 1 of 12 |
| Edema limbs | General disorders | 1 of 52 | 0 of 26 | 1 of 12 |
| Fatigue | General disorders | 1 of 52 | 0 of 26 | 1 of 12 |
| Dehydration | Metabolism and nutrition disorders | 0 of 52 | 2 of 26 | 0 of 12 |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | 1 of 52 | 1 of 26 | 0 of 12 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 52 | 1 of 26 | 0 of 12 |
| Confusion | Psychiatric disorders | 0 of 52 | 2 of 26 | 0 of 12 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1 of 52 | 1 of 26 | 0 of 12 |
| Anemia | Blood and lymphatic system disorders | 1 of 52 | 0 of 26 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I (Tivantinib) | Arm II (Placebo) | Crossover From Placebo to Tivantinib |
|---|---|---|---|---|
| Fatigue | General disorders | 30 of 52 | 11 of 26 | 7 of 12 |
| Anemia | Blood and lymphatic system disorders | 23 of 52 | 12 of 26 | 6 of 12 |
| Anorexia | Metabolism and nutrition disorders | 17 of 52 | 5 of 26 | 6 of 12 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 13 of 52 | 11 of 26 | 2 of 12 |
| Back pain | Musculoskeletal and connective tissue disorders | 9 of 52 | 13 of 26 | 3 of 12 |
| Constipation | Gastrointestinal disorders | 14 of 52 | 7 of 26 | 3 of 12 |
| Lymphocyte count decreased | Investigations | 11 of 52 | 6 of 26 | 4 of 12 |
| Aspartate aminotransferase increased | Investigations | 13 of 52 | 3 of 26 | 2 of 12 |
| White blood cell decreased | Investigations | 12 of 52 | 1 of 26 | 5 of 12 |
| Nausea | Gastrointestinal disorders | 9 of 52 | 5 of 26 | 3 of 12 |
Serious events with the highest arm-level rate: death nos (8.3%), edema limbs (8.3%), fatigue (8.3%), urinary tract obstruction (8.3%), pleural effusion (8.3%).
The registry record lists serious adverse events among 19 of 52 participants in the tivantinib arm and 22 of 26 in the placebo arm. For the crossover group, it lists 5 of 12 participants with serious adverse events. Deaths are listed for 7 participants in the tivantinib arm, 4 in the placebo arm and 0 in the crossover group. These are descriptive counts in the registry record; they do not establish that treatment caused an event or death.
The record also lists serious-event terms including Death NOS, edema limbs, fatigue, urinary tract obstruction, pleural effusion and dehydration. The displayed percentages for these terms range from 7.7% to 8.3%. The registry record does not provide enough detail to interpret these as comparative risks or to establish whether events were related to study treatment.
Safety comparisons require attention to group size, duration of exposure, event definitions, follow-up and crossover. Those details are not reported in full in the registry record. The crossover group should be kept separate from the original randomized arms, and serious adverse events should not be conflated with all adverse events. The record does not report the listed secondary outcome of grade 3, 4 or 5 adverse-event incidence with quantitative results.
13. What the Result Does, and Does Not, Mean
The primary result describes a difference in the reported PFS distributions between the randomized arms, with median PFS of 5.5 months for tivantinib and 3.7 months for placebo. The registry record reports a log-rank p-value of 0.02. This is a statistical comparison of time-to-event distributions in this trial, not a guarantee about an individual participant’s outcome.
The result does not establish the size of a relative treatment effect because a hazard ratio is not reported. Nor does the median comparison alone show how many participants had an event at any particular time, how the event rates changed over follow-up, or whether progression or death was the more frequent component. Those details are not reported in the registry record.
The estimates are uncertain, as reflected by their 95% confidence intervals. The trial’s crossover structure, the absence of detailed follow-up and analysis-population information, and the lack of a reported multiplicity approach for secondary outcomes also matter when interpreting the overall evidence. These limitations do not change the reported median values or p-value, but they constrain the additional conclusions that can be drawn from them.
The secondary outcomes are distinct measures and do not independently settle the primary question. Their interpretation is limited by sparse response observations, uncertainty and the absence of reported inferential analyses. Safety counts are descriptive and should not be interpreted as proof of causation or as a complete comparative safety assessment.
In short, the registry record reports a statistically significant log-rank comparison for PFS in this phase II trial. It does not establish a definitive effect in other populations or settings, and it does not answer every question about benefit, harms or longer-term outcomes. These results are statistical information, not medical advice.
14. Why This Trial Matters Statistically
This trial illustrates why time-to-event outcomes are not adequately summarized by a single number. The medians provide an accessible description of each arm, while the log-rank test compares event-time distributions over follow-up. The difference between those tasks is important: an inferential comparison uses more of the event-time pattern than a comparison of the two medians alone.
It also illustrates the importance of matching an analysis to the data structure. PFS includes progression and death, and follow-up may end without either event being observed. Kaplan-Meier methods are designed to describe such time-to-event data while accounting for censoring. But assessment of the resulting estimate also depends on event counts, censoring patterns and analysis rules, details that are not reported in the registry record.
The crossover design raises a further statistical distinction between initial randomized assignment and later treatment received. Placebo participants could cross over after progression, so the later experience of the crossover group is not equivalent to a new randomized comparison. Transparent reporting of how that transition is handled is important for interpreting any treatment contrast.
Finally, this record includes several distinct secondary outcomes, while the multiplicity strategy and detailed secondary analyses are not reported. That makes it useful to separate the primary inferential result from exploratory outcome patterns. The trial demonstrates how a reported p-value, confidence intervals, endpoint definitions, analysis methods and missing methodological details all contribute to a careful statistical reading.
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 posted PFS results are summary estimates rather than a full event-time analysis. Event counts, censoring patterns, follow-up distribution and detailed assessment timing are not reported in the registry record. A hazard ratio and its confidence interval are also absent, limiting interpretation of relative event rates and preventing comparison with a Cox-model estimate.
The record describes a placebo-to-tivantinib crossover after progression and lists a crossover group. It does not report how crossover was handled in the primary analysis, whether the analysis followed initial assignment, or whether analyses adjusted for treatment received. The crossover results should not be treated as another randomized arm.
The registry record does not report the analysis population, missing-data procedures, detailed randomization methods, baseline characteristics, sample-size justification, interim analyses, sensitivity analyses or multiplicity strategy. These gaps limit assessment of the analysis plan and the robustness of secondary findings. Numerical secondary results are available for selected response outcomes, but the record does not report sponsor inferential analyses for them. Quantitative results for PSA changes and the listed grade 3, 4 or 5 adverse-event incidence are not reported in the registry record.
The safety information is descriptive and does not establish causality. The registry record does not provide a complete account of exposure duration or enough comparative detail to interpret the serious adverse-event counts as a full safety assessment. Finally, the study is identified as phase II, and its reported results concern the enrolled trial population and the specified follow-up period; broader conclusions are not established by these registry results alone.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Tivantinib in Treating Patients With Metastatic Prostate Cancer — NCT01519414.
- Registry record last updated 2018-09-12; status last verified 2018-08.
- Results first posted 2018-09-12.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT01519414 is a completed randomized, double-blind, placebo-controlled phase II study sponsored by the National Cancer Institute (NCI). It enrolled 78 men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The primary outcome was PFS based on RECIST criteria, measured from study entry to documented progression and/or death and assessed up to 6 months.
The registry record reports median PFS of 5.5 months for tivantinib and 3.7 months for placebo, with 95% confidence intervals of 3.2 to 8.0 months and 2.7 to 5.4 months, respectively. The reported log-rank p-value is 0.02. The record describes a placebo-to-tivantinib crossover after progression, but does not report detailed handling of crossover in the primary analysis.
Response outcomes and descriptive serious adverse-event information are also posted. Important details—including a hazard ratio, analysis population, missing-data methods and multiplicity strategy—are not reported in the registry record.