Trial · NCT00502307
A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma
NCT00502307, Phase 2, Completed, AVEO Pharmaceuticals, Inc.; results first posted 2020-09-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma. Trials, record NCT00502307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00502307
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma
- NCT number
- NCT00502307
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 272 participants, actual
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Tivozanib (AV-951), Placebo comparator
- First posted
- 2007-07-17
- Last updated
- 2020-09-01
- Results first posted
- 2020-09-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | 28 weeks after study entry | To determine the safety and tolerability of tivozanib (AV-951) with the protocol-specified dose schedule |
| Primary | Objective Response [Complete Response (CR) + Partial Response (PR)] Rate at 16 Week Open-Label Period (All Treated Population) | 16 weeks after study entry | The ORR is defined as the rate of (CR+PR). Objective response rates following the 16-week, open-label period (investigator assessment and IRR assessment) were estimated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and was assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Overall Response (OR) = CR + PR. |
| Primary | Percentage of Randomly Assigned Subjects Remaining Progression Free at 12 Weeks Following Random Assignment to Tivozanib (AV-951) or Placebo | 28 weeks after study entry | Percentages of subjects remaining progression-free at 12 weeks post-randomization were compared across the 2 treatment arms in the ITT population. A Cochran-Mantel- Haenszel (CMH) test of general association was used, stratifying by country to evaluate the null hypothesis that treatment arm is not associated with subjects remaining progression-free. Non-completers were treated as failures. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Subjects With Progression Free-survival (PFS) After Random Assignment (Randomized Sub-set Only) (at 12 Weeks Post Randomization ) | 28 weeks from study entry | PFS after randomization in the ITT population was described using the Kaplan-Meier methodology. PFS was compared across treatment arms using the log-rank test. |
| Secondary | Overall Progression-free Survival (From Start of Treatment) | 12 months from study entry | Number of subjects with Overall PFS (from start of treatment) was estimated using the Kaplan-Meier methodology. Subjects randomized to receive placebo were censored at randomization. Withdrawals are also censored. An alternative analysis was conducted in which PFS for subjects randomized to receive tivozanib was weighted more heavily to compensate for the information loss from randomization of other subjects to receive placebo. Additional analyses in which withdrawal was considered a PFS event were also conducted. |
| Secondary | Time to Peak Plasma Concentration (Tmax) of Tivozanib in a Subset of Subjects | Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose | Tivozanib concentrations in human serum were determined. The PK population included all subjects who had taken at least 1 dose of tivozanib and whose PK profile(s) were evaluable. All subjects received 1.5 mg tivozanib (1.3397 mg free base) in Cycle 1. |
| Secondary | Maximum Observed Serum Concentration During a Dosing Interval at Steady State (Cmax) | Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose | Tivozanib concentrations in human serum were determined. The PK population included all subjects who had taken at least 1 dose of tivozanib and whose PK profile(s) were evaluable. All subjects received 1.5 mg tivozanib (1.3397 mg free base) in Cycle 1. |
| Secondary | Area Under the Serum Concentration Versus Time Curve From Zero to the Last Quantifiable Sampling Point [AUC(0→24)] | 28 weeks from study entry | Tivozanib concentrations in human serum were determined. The PK population included all subjects who had taken at least 1 dose of tivozanib and whose PK profile(s) were evaluable. All subjects received 1.5 mg tivozanib (1.3397 mg free base) in Cycle 1. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | 28 weeks after study entry | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Objective Response [Complete Response (CR) + Partial Response (PR)] Rate at 16 Week Open-Label Period (All Treated Population) | 16 weeks after study entry | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Randomly Assigned Subjects Remaining Progression Free at 12 Weeks Following Random Assignment to Tivozanib (AV-951) or Placebo | 28 weeks after study entry | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects With Progression Free-survival (PFS) After Random Assignment (Randomized Sub-set Only) (at 12 Weeks Post Randomization ) | 28 weeks from study entry | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Progression-free Survival (From Start of Treatment) | 12 months from study entry | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Peak Plasma Concentration (Tmax) of Tivozanib in a Subset of Subjects | Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose | The PK population had 21 subjects. However, there were subjects with missing data for both Cycle 1 Day 1 and Cycle 1 Day 21. Hence, the number of participants analyzed varies i.e, 20 for Cycle 1 Day 1 and 16 for Cycle 1 Day 21. | hours | MEAN |
| SECONDARY | Maximum Observed Serum Concentration During a Dosing Interval at Steady State (Cmax) | Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose | The PK population had 21 subjects. However, there were subjects with missing data for both Cycle 1 Day 1 and Cycle 1 Day 21. Hence, the number of participants analyzed varies i.e, 20 for Cycle 1 Day 1 and 16 for Cycle 1 Day 21. | ng/mL | MEAN |
| SECONDARY | Area Under the Serum Concentration Versus Time Curve From Zero to the Last Quantifiable Sampling Point [AUC(0→24)] | 28 weeks from study entry | The PK population had 21 subjects. However, there were subjects with missing data for both Cycle 1 Day 1 and Cycle 1 Day 21. Hence, the number of participants analyzed varies i.e, 20 for Cycle 1 Day 1 and 16 for Cycle 1 Day 21. | h*ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Open-label Period: Tivozanib (AV-951) | Adverse events | 215 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Tivozanib (AV-951) | Adverse events | 31 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Placebo | Adverse events | 32 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Open-label Period: Tivozanib (AV-951) | Serious adverse events | 16 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Tivozanib (AV-951) | Serious adverse events | 2 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Placebo | Serious adverse events | 3 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Open-label Period: Tivozanib (AV-951) | Grade 3 or higher adverse events | 86 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Tivozanib (AV-951) | Grade 3 or higher adverse events | 8 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Double-blind Period: Placebo | Grade 3 or higher adverse events | 10 | Participants | |
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | Open-label Period: Tivozanib (AV-951) | Treatment-related adverse events | 174 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Period (16 Weeks) | STARTED | Open-label Period: Tivozanib (AV-951) | 272 | |
| Open Label Period (16 Weeks) | STARTED | Double-blind Period: Tivozanib (AV-951) | 0 | |
| Open Label Period (16 Weeks) | STARTED | Double-blind Period: Placebo | 0 | |
| Open Label Period (16 Weeks) | COMPLETED | Open-label Period: Tivozanib (AV-951) | 196 | |
| Open Label Period (16 Weeks) | COMPLETED | Double-blind Period: Tivozanib (AV-951) | 0 | |
| Open Label Period (16 Weeks) | COMPLETED | Double-blind Period: Placebo | 0 | |
| Open Label Period (16 Weeks) | NOT COMPLETED | Open-label Period: Tivozanib (AV-951) | 76 | |
| Open Label Period (16 Weeks) | NOT COMPLETED | Double-blind Period: Tivozanib (AV-951) | 0 | |
| Open Label Period (16 Weeks) | NOT COMPLETED | Double-blind Period: Placebo | 0 | |
| Double-Blind Period (12 Weeks) | STARTED | Open-label Period: Tivozanib (AV-951) | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events129
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Open-label Period: Tivozanib (AV-951) | 32 | 272 | 49 |
| other | Asthenia | General disorders | Double-blind Period: Tivozanib (AV-951) | 6 | 61 | 9 |
| other | Asthenia | General disorders | Double-blind Period: Placebo | 7 | 57 | 7 |
| other | Fatigue | General disorders | Open-label Period: Tivozanib (AV-951) | 29 | 272 | 45 |
| other | Fatigue | General disorders | Double-blind Period: Tivozanib (AV-951) | 2 | 61 | 2 |
| other | Fatigue | General disorders | Double-blind Period: Placebo | 4 | 57 | 6 |
| other | Pyrexia | General disorders | Open-label Period: Tivozanib (AV-951) | 14 | 272 | 16 |
| other | Pyrexia | General disorders | Double-blind Period: Tivozanib (AV-951) | 0 | 61 | 0 |
| other | Pyrexia | General disorders | Double-blind Period: Placebo | 2 | 57 | 2 |
| other | Non-cardiac chest pain | General disorders | Open-label Period: Tivozanib (AV-951) | 10 | 272 | 11 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Period: Tivozanib (AV-951) | ||
| Total, all-cause mortality | Double-blind Period: Tivozanib (AV-951) | ||
| Total, all-cause mortality | Double-blind Period: Placebo | ||
| Total, other adverse events | Open-label Period: Tivozanib (AV-951) | 215 | 272 |
| Total, other adverse events | Double-blind Period: Tivozanib (AV-951) | 31 | 61 |
| Total, other adverse events | Double-blind Period: Placebo | 32 | 57 |
| Total, serious adverse events | Open-label Period: Tivozanib (AV-951) | 16 | 272 |
| Total, serious adverse events | Double-blind Period: Tivozanib (AV-951) | 2 | 61 |
| Total, serious adverse events | Double-blind Period: Placebo | 3 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37315114 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00502307
GET https://conductscience.org/api/trials/v1/NCT00502307/results?page=2