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 An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301). (NCT01076010), a non-randomized phase 3 study. The primary outcome is Number of Days Subjects Received Treatment in Each Treatment Arm.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01076010 |
| Phase | Phase 3 |
| Condition | Advanced Renal Cell Carcinoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 277 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AVEO Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The protocol concerned participants with advanced renal cell carcinoma who had taken part in the parent AV-951-09-301 study. Eligibility for the extension depended on prior treatment assignment and clinical circumstances: some participants had documented disease progression on sorafenib, while others had clinical benefit and acceptable tolerability on their assigned treatment. The registry record does not report further eligibility details or the characteristics of the participants included in each treatment group.
Intervention
The extension offered tivozanib or sorafenib. Participants who had received sorafenib in the parent study and had documented progression could receive tivozanib at 1.5 mg/day. Participants with clinical benefit and acceptable tolerability could continue tivozanib or sorafenib at the same dose and schedule as in the parent study. These pathways describe access to treatment in an extension protocol, rather than a new randomized assignment.
Comparator
The registry lists a sorafenib-to-tivozanib crossover group, a first-line tivozanib group, and a first-line sorafenib group. Allocation in the extension was non-randomized, and the registry explicitly cautions that the groups are not a like-for-like control comparison. Their results should therefore be read as outcomes within different treatment histories, not as a randomized estimate of the relative effect of the two drugs.
Primary question
The primary endpoint asks how many days participants received treatment in each treatment arm. The registry describes follow-up from enrollment until participants discontinued because of documented progressive disease or unacceptable toxicities, or until 3 years after the first participant entered the extension. The record identifies the mean and standard deviation as the summary measures, but numerical results for this endpoint are not reported in the registry record.
3. Trial Design
This was an open-label, multi-center extension treatment protocol for participants who had taken part in AV-951-09-301, a Phase 3 study of tivozanib versus sorafenib in renal cell carcinoma. The extension is registered as non-randomized, unmasked, and parallel. These design features matter when interpreting outcomes: treatment pathways depended on participants’ prior assignments and circumstances, rather than on a new randomized comparison within the extension.
The protocol’s purpose, as described in the registry, was to allow access to tivozanib and sorafenib. Participants who had been assigned sorafenib in the parent study and had documented progression could cross over to tivozanib. Participants assigned either treatment in the parent study could continue that treatment if they demonstrated clinical benefit and acceptable tolerability. The listed arms distinguish crossover treatment from continued first-line treatment. They therefore represent different treatment histories and selection conditions.
The registry reports an enrollment of 277 and a completed status. The start is recorded as 2010-03, and primary completion as 2014-07. These record dates do not, on their own, establish the timing of every participant’s treatment or follow-up. The treatment-duration timeframe is described as continuing until discontinuation for documented progressive disease or unacceptable toxicities, or until 3 years after the first participant entered the extension.
The registry lists tivozanib and sorafenib as the interventions. It also names objective response rate among participants who continued treatment or received tivozanib after sorafenib failure, duration of response, progression-free survival, and overall survival as secondary outcomes. Numerical findings for these outcomes are not reported in the registry record. Details of the parent study’s allocation procedures, beyond the description of participants as randomized to treatment there, 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: All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.
Overall Study
| Stage | Sorafenib Crossover to Tivozanib | First Line Tivozanib. | First Line Sorafenib. |
|---|---|---|---|
| STARTED | 161 | 88 | 28 |
| COMPLETED | 36 | 49 | 26 |
| NOT COMPLETED | 125 | 39 | 2 |
Reasons for not completing this period:
| Reason | Sorafenib Crossover to Tivozanib | First Line Tivozanib. | First Line Sorafenib. |
|---|---|---|---|
| Death | 15 | 1 | 0 |
| Adverse Event | 7 | 2 | 0 |
| Progressive disease | 90 | 30 | 1 |
| Lack of Efficacy | 4 | 0 | 0 |
| Treatment Interruption for > 2 Weeks | 0 | 1 | 0 |
| Significant Surgical Procedure | 0 | 1 | 0 |
| Protocol Violation | 0 | 1 | 0 |
| Noncompliance | 1 | 1 | 0 |
| Withdrawal by Subject | 3 | 0 | 1 |
| Other | 5 | 2 | 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 | Sorafenib Crossover to Tivozanib | First Line Tivozanib | First Line Sorafenib | Total |
|---|---|---|---|---|---|
| Participants analysed | 161 | 88 | 28 | 277 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 120 | 58 | 17 | 195 |
| Age, Categorical: >=65 years | Participants | 41 | 30 | 11 | 82 |
| Sex: Female, Male: Female | Participants | 46 | 33 | 9 | 88 |
| Sex: Female, Male: Male | Participants | 115 | 55 | 19 | 189 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 7 | 2 | 0 | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 154 | 84 | 28 | 266 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 0 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 5 | 1 | 0 | 6 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 156 | 87 | 28 | 271 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Days Subjects Received Treatment in Each Treatment Arm, measured over From enrollment to until all subjects discontinue (due to documented progressive disease [PD] or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Days |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the number of days participants received treatment in each treatment arm. Treatment duration is a continuous measure of time spent receiving study treatment. It can describe how long participants remained on their assigned or crossover treatment before discontinuation, but it does not by itself explain why treatment ended or establish a comparative treatment effect.
The registry says discontinuation could occur because of documented progressive disease or unacceptable toxicities. Its description also refers to clinical progression and unacceptable toxicities, while the timeframe specifies documented progressive disease or unacceptable toxicities, or the stated follow-up limit. These reasons are relevant context because treatment duration can reflect multiple clinical and operational circumstances. Without participant-level reasons for stopping or further endpoint detail, the mean alone would not distinguish among them.
The stated summary is the mean number of days, with standard deviation as the measure of dispersion. The mean gives a central summary of observed duration; the standard deviation describes how spread out individual durations are around that mean. The registry record does not report the mean or standard deviation values, the number of participants contributing to each endpoint analysis, or confidence intervals. Consequently, the endpoint’s numerical level, variability, and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies treatment duration as the primary endpoint but does not report numerical results for it. Although the endpoint is defined as days on treatment and the planned descriptive summaries are the mean and standard deviation, neither value is available in the registry record. It is therefore not possible to describe the observed average duration, its spread, or the precision of an estimate from this record.
The treatment groups require particular care in interpretation. The extension was non-randomized and unmasked. Participants entered different pathways according to their prior treatment and whether they had progression or continued to have clinical benefit and acceptable tolerability. For that reason, an apparent difference in treatment duration between the listed groups would not, by itself, represent a fair comparison of tivozanib and sorafenib. Differences could reflect the distinct treatment histories and eligibility conditions that defined the groups. The registry explicitly states that the arms are not a like-for-like control comparison.
The listed secondary outcomes include objective response rate, duration of response, progression-free survival, and overall survival. Their names identify what the protocol planned to assess, but do not establish what was observed. Numerical results, uncertainty estimates, and analysis details for these outcomes are not reported in the registry record. No response or survival conclusion can be drawn from outcome labels alone.
Safety information is also presented by treatment pathway. The registry lists serious-event and other-event at-risk and affected fields for the groups, and it identifies several serious-event terms at 3.6%. These entries describe reported safety fields, not a randomized comparison. The record does not report deaths in these fields, and it does not provide enough detail to determine from these entries alone how events were counted, when they occurred, or whether an event could be represented in more than one term.
Confidence intervals, p-values, adjusted estimates, and a detailed statistical analysis plan are not reported in the registry record. A confidence interval, as a general statistical concept, describes the uncertainty around an estimate under the assumptions of the method used. Without a reported estimate and its uncertainty, readers cannot assess statistical precision for the primary endpoint from this record. The most defensible interpretation is limited to the protocol’s stated design, outcome definitions, and listed safety figures; the registry record does not support a numerical efficacy comparison.
9. Statistical Methods Explained
The primary endpoint is continuous: it records treatment duration in days. The registry specifies the mean as the summary measure and the standard deviation as the dispersion measure. These quantities answer different descriptive questions. The mean is a measure of the center of the observed durations, while the standard deviation describes how much individual durations vary around that center. Neither measure is reported numerically for the primary endpoint in the registry record, so the observed distribution and average cannot be assessed from the record.
What does the mean describe?
As a general statistical explanation, a mean combines the observed values into a single measure of central tendency. It can be useful for describing treatment time, but its meaning depends on the underlying distribution and on which participants contributed data. If a small number of durations are particularly long or short, the mean can be influenced by them. A mean also does not show whether durations were similar across participants or concentrated in different patterns. The registry record does not report the individual values, a median, or other distributional summaries for this endpoint.
What does the standard deviation add?
As a general explanation, standard deviation describes variability among observations around their mean. It is not the same as the uncertainty of the estimated mean. A standard deviation reflects spread among the measured durations; a confidence interval or standard error concerns the precision of an estimate. The registry names standard deviation as the endpoint’s dispersion measure but does not report its value. It also does not report a confidence interval or standard error for the mean, so neither variability nor inferential precision can be quantified from the record.
Why does the treatment pathway matter?
In a randomized comparison, allocation is intended to balance factors that could affect outcomes across groups, on average. That general principle does not make every randomized trial free of uncertainty, but it helps explain why randomization supports causal comparisons. This extension was non-randomized. Its groups arose from prior treatment assignment and clinical eligibility: participants could continue treatment if they had clinical benefit and acceptable tolerability, while eligible participants with documented progression on sorafenib could receive tivozanib. Group membership therefore reflects different histories and selection conditions. Comparisons between group summaries should not be interpreted as if treatment had been newly randomized in the extension.
The registry also records no masking. In general, an open-label design means treatment assignment is not concealed from participants and study personnel. This can be relevant to treatment decisions, reporting, and assessment, although the record does not establish whether or how such influences affected this study. Details about endpoint adjudication or blinding of outcome assessment are not reported in the registry record.
What can the planning assumptions tell readers?
The sample-size calculations are described as planning illustrations based on the observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are assumptions for interpreting a planning exercise, not a report of what was observed. The registry record does not report the numerical observed effect or the numerical planning results in the information available for this analysis. Such calculations should not be described as observed power, and they do not establish the precision of the results actually obtained.
In general, a sample-size calculation estimates the number of participants needed under specified assumptions to detect a selected effect with a chosen statistical procedure. Its result depends on the assumed effect and other design choices. Changing those assumptions can change the planning estimate. Here, the registry characterizes the calculations as illustrations rather than as the trial’s design justification. A sample-size illustration cannot substitute for reporting the observed endpoint estimate, its uncertainty, or the analysis population.
Why can event counts require special care?
As a general statistical matter, event data can be difficult to compare when participants contribute different amounts of follow-up, when recurrent events are possible, or when event definitions and ascertainment differ. A simple count does not account for exposure time unless the analysis explicitly uses an appropriate rate or time-to-event method. The registry lists safety fields by treatment group but does not report a detailed event-counting method, exposure-adjusted rates, or a statistical comparison. The safety entries should therefore be read as descriptive registry figures, not as comparative estimates.
For outcomes such as progression-free survival or overall survival, general methods often account for differing follow-up and censoring, where an outcome time is not observed for every participant. The registry names these outcomes, but the analysis methods, censoring rules, estimates, and uncertainty are not reported in the registry record. It is not appropriate to infer a particular survival method from the outcome names alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 10 analyses, and names secondary outcomes that include objective response rate, duration of response, progression-free survival, and overall survival. The registry record does not report which analyses correspond to which outcomes, which outcomes were designated as confirmatory, or whether any adjustment for multiple comparisons was planned or used. Multiplicity methods and a hierarchy for interpreting outcomes are therefore not reported in the registry record.
As a general statistical concept, evaluating multiple outcomes or multiple analyses can increase the chance of finding an apparently notable result by chance if each is interpreted independently. Methods for handling multiplicity can include prespecifying a hierarchy or adjusting inference, but the record does not state that any such method was used. No unreported adjustment should be assumed.
Missing-data procedures are not reported in the registry record. The record does not describe how missing endpoint measurements, withdrawals, or incomplete follow-up were handled, nor does it provide the number of participants included in each endpoint analysis. It also does not report imputation methods, sensitivity analyses, or rules for censoring time-to-event outcomes.
Analysis populations are not reported in the registry record. In particular, the record does not specify whether analyses used all enrolled participants, participants who received treatment, or another defined population. The enrollment figure should not be treated as the denominator for every outcome without analysis-specific information. These omissions limit assessment of how much data contributed to each result and whether the analyses followed a prespecified statistical plan.
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 |
|---|---|---|---|
| Sorafenib Crossover to Tivozanib | 49 | 161 | 30.4% |
| First Line Tivozanib | 17 | 88 | 19.3% |
| First Line Sorafenib | 4 | 28 | 14.3% |
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 |
|---|---|
| Sorafenib Crossover to Tivozanib | 87 of 161 |
| First Line Tivozanib | 82 of 88 |
| First Line Sorafenib | 28 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Sorafenib Crossover to Tivozanib | First Line Tivozanib | First Line Sorafenib |
|---|---|---|---|---|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 161 | 0 of 88 | 0 of 28 |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 161 | 0 of 88 | 0 of 28 |
| Death | General disorders | 2 of 161 | 1 of 88 | 0 of 28 |
| Anaemia | Blood and lymphatic system disorders | 3 of 161 | 0 of 88 | 0 of 28 |
| Acute myocardial infarction | Cardiac disorders | 2 of 161 | 0 of 88 | 0 of 28 |
| Cardiac failure | Cardiac disorders | 2 of 161 | 0 of 88 | 0 of 28 |
| Myocardial infarction | Cardiac disorders | 2 of 161 | 0 of 88 | 0 of 28 |
| Arteriosclerosis coronary artery | Cardiac disorders | 1 of 161 | 1 of 88 | 0 of 28 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 161 | 0 of 88 | 0 of 28 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 161 | 0 of 88 | 0 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sorafenib Crossover to Tivozanib | First Line Tivozanib | First Line Sorafenib |
|---|---|---|---|---|
| Hypertension | Vascular disorders | 41 of 161 | 44 of 88 | 16 of 28 |
| Diarrhoea | Gastrointestinal disorders | 22 of 161 | 35 of 88 | 12 of 28 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 16 of 161 | 21 of 88 | 16 of 28 |
| Fatigue | General disorders | 21 of 161 | 20 of 88 | 3 of 28 |
| Asthenia | General disorders | 20 of 161 | 20 of 88 | 3 of 28 |
| Weight decreased | Investigations | 0 of 161 | 21 of 88 | 9 of 28 |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 9 of 161 | 16 of 88 | 0 of 28 |
| Cough | Respiratory, thoracic and mediastinal disorders | 9 of 161 | 13 of 88 | 2 of 28 |
| Decreased appetite | Metabolism and nutrition disorders | 9 of 161 | 11 of 88 | 2 of 28 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 9 of 161 | 10 of 88 | 3 of 28 |
Serious events with the highest arm-level rate: pleurisy (3.6%), renal failure acute (3.6%), salivary gland mass (3.6%), device related infection (3.6%), diverticulitis (3.6%).
The registry lists safety fields separately for the sorafenib crossover to tivozanib, first-line tivozanib, and first-line sorafenib groups. For serious events, the at-risk and affected figures are 161 and 49 for sorafenib crossover to tivozanib, 88 and 17 for first-line tivozanib, and 28 and 4 for first-line sorafenib. For other events, the corresponding at-risk and affected figures are 161 and 87, 88 and 82, and 28 and 28. These are the registry’s group-specific entries; they should not be read as a randomized safety comparison.
The listed serious-event terms are pleurisy, renal failure acute, salivary gland mass, device related infection, diverticulitis, and peripheral ischaemia, each reported as 3.6%. The record does not specify in these entries whether participants could contribute more than one event term or how the percentages were calculated. Deaths are not reported in the registry record. Differences between these group figures cannot establish that one treatment has a different safety profile, particularly given the non-randomized design and distinct treatment histories.
12. What the Result Does, and Does Not, Mean
The record establishes that this was an extension protocol offering continued access to tivozanib or sorafenib, with crossover to tivozanib available to eligible participants who had progressed on sorafenib in the parent study. It also establishes that the primary endpoint was treatment duration in days and that the registry intended to summarize it using a mean and standard deviation. The numerical primary endpoint results are not reported in the registry record.
That absence matters: a defined endpoint is not itself a finding. Without the mean, standard deviation, analysis population, or precision estimate, the record cannot show how long participants typically remained on treatment or how variable their treatment durations were. The listed secondary outcomes likewise do not establish response or survival results; numerical findings for them are not reported in the registry record.
The extension’s non-randomized design also limits causal interpretation. The groups were shaped by prior assignment and eligibility conditions, including progression on sorafenib or continuing clinical benefit and acceptable tolerability. A difference in an outcome across these groups could reflect those characteristics as well as treatment exposure. The registry explicitly warns that the arms are not a like-for-like control comparison. Accordingly, group-level descriptions should not be presented as proof that one treatment caused a better or worse outcome.
The safety entries provide counts and listed serious-event terms, but do not supply a randomized comparison or detailed methods for interpreting event occurrence. They offer descriptive context and should not be used alone to make claims about comparative risk. Overall, the registry record supports a description of the protocol’s structure, endpoint, and listed safety information, but it does not provide the numerical primary outcome or statistical detail required for an efficacy comparison.
13. Why This Trial Matters Statistically
This protocol is statistically important to read in light of its purpose. It was an extension treatment protocol intended to allow access to tivozanib and sorafenib after participation in the parent study. Extension access can address a different question from a randomized efficacy trial: how treatment is continued or offered to eligible participants with particular prior treatment histories. That purpose shapes both the groups and the limits of comparison.
The registry distinguishes continued treatment from crossover after progression, rather than presenting newly randomized treatment arms. This makes the treatment pathways clinically and analytically different. The contrast between them is not equivalent to a controlled comparison, and the registry explicitly cautions against treating the arms as like-for-like. Recognizing this distinction prevents descriptive group figures from being mistaken for a causal estimate.
The primary endpoint is also a useful example of why an outcome definition and its results must be considered separately. Treatment duration is clearly named, with a mean and standard deviation specified, but those numerical results are not reported in the registry record. Without those estimates and information about the analyzed participants, statistical interpretation cannot move from the endpoint definition to a quantified description of observed treatment duration.
Finally, the record illustrates why registry entries should be read with attention to what is reported and what remains unspecified. The protocol names several secondary outcomes and lists safety fields, but does not report the numerical findings for the primary endpoint, detailed analysis methods, or multiplicity and missing-data procedures. This distinction is central to responsible statistical interpretation: design and outcome labels provide context, while estimates, uncertainty, and analysis details are needed to evaluate results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report numerical results for the primary endpoint, including the mean treatment duration and standard deviation. It also does not report confidence intervals or other precision measures for that endpoint. This prevents quantitative interpretation of the primary outcome from the record.
The non-randomized allocation and the different eligibility pathways limit comparisons among groups. Participants in the crossover group had documented progression on sorafenib, while participants continuing first-line treatment were described as having clinical benefit and acceptable tolerability. These differing conditions can affect outcomes and make direct treatment comparisons difficult. The record itself cautions that the arms are not a like-for-like control comparison.
Further limitations concern analysis detail. The registry record does not report endpoint-specific analysis populations, missing-data procedures, censoring rules, or a detailed statistical analysis plan. It does not report whether multiplicity was addressed. Numerical results for the listed secondary outcomes are also not reported in the registry record. As a result, readers cannot assess how those outcomes were analyzed or how much information contributed to them.
The safety fields do not include detailed event definitions or counting procedures, and deaths are not reported in the registry record. The listed figures should not be taken as exposure-adjusted comparisons. The registry’s description of follow-up provides a time limit and reasons for discontinuation, but does not report participant-level follow-up or the distribution of treatment durations. These limitations are specific to the information recorded for this extension and constrain conclusions about both outcomes and comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301). — NCT01076010.
- Registry record last updated 2020-10-05; status last verified 2020-09.
- Results first posted 2020-10-05.
- 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
NCT01076010 is an open-label, multi-center extension treatment protocol for participants from the Phase 3 AV-951-09-301 study of tivozanib versus sorafenib in renal cell carcinoma. The registry records the extension as non-randomized, unmasked, parallel, and completed, with enrollment of 277. The recorded start is 2010-03 and primary completion is 2014-07.
Eligible participants could continue tivozanib or sorafenib after clinical benefit and acceptable tolerability, or participants with documented progression on sorafenib could receive tivozanib at 1.5 mg/day. The primary endpoint is days receiving treatment, summarized by mean and standard deviation. Numerical primary endpoint results and numerical findings for the named secondary outcomes are not reported in the registry record. The registry warns that the treatment groups are not a like-for-like control comparison.