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This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.
Approximately 200 patients will be enroled into the initial, 16 week, open-label period using 1.5 mg/day dosing. Patients will receive tivozanib (AV-951) continuously for 3 weeks followed by 1 week off study drug. Patients will undergo disease assessment at baseline and after Cycles 2 and 4 and response will be determined by RESIST criteria.
After the initial, 16 week open-label period, disease status will be assessed and compared to baseline using modified RECIST criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tivozanib (AV-951) administered as a solid dosage form daily for three weeks per month |
|
| 2 | Placebo Comparator | solid oral capsule containing excipients dosed daily for three weeks per month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tivozanib (AV-951) | Drug | solid oral dosage form taken daily for three weeks per one month cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | To determine the safety and tolerability of tivozanib (AV-951) with the protocol-specified dose schedule | 28 weeks after study entry |
| Objective Response [Complete Response (CR) + Partial Response (PR)] Rate at 16 Week Open-Label Period (All Treated Population) | 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. | 16 weeks after study entry |
| Percentage of Randomly Assigned Subjects Remaining Progression Free at 12 Weeks Following Random Assignment to Tivozanib (AV-951) or Placebo | 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. | 28 weeks after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Progression Free-survival (PFS) After Random Assignment (Randomized Sub-set Only) (at 12 Weeks Post Randomization ) | 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. | 28 weeks from study entry |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women
Primary CNS malignancies; active CNS metastases
Hematologic malignancies (includes: leukemia, any form; lymphoma; and multiple myeloma)
Any of the following hematologic abnormalities:
Any of the following serum chemistry abnormalities:
Significant cardiovascular disease, including:
Unhealed wounds (including active gastric ulcers)
Serious/active infection; infection requiring parenteral antibiotics
Inadequate recovery from prior antineoplastic therapy
Inadequate recovery from any prior surgical procedure; major surgical procedure within 4 weeks prior to study entry
Life-threatening illness or organ system dysfunction compromising safety evaluation
Psychiatric disorder, altered mental status precluding informed consent or necessary testing
Inability to comply with protocol requirements
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| Name | Affiliation | Role |
|---|---|---|
| Dmitriy G Nosov, M.D. | Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vellore | Tamil Nadu | 632004 | India | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315114 | Derived | Barata PC, Chehrazi-Raffle A, Allman KD, Asnis-Alibozek A, Kasturi V, Pal SK. Activity of Tivozanib in Non-clear Cell Renal Cell Carcinoma: Subgroup Analysis From a Phase II Randomized Discontinuation Trial. Oncologist. 2023 Oct 3;28(10):894-900. doi: 10.1093/oncolo/oyad132. |
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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.
Participants who met all the inclusion and none of the exclusion criteria were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Period: Tivozanib (AV-951) | Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open Label Period (16 Weeks) |
|
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| Placebo comparator |
| Drug |
solid oral capsule containing excipients dosed daily for three weeks per month |
|
| Overall Progression-free Survival (From Start of Treatment) |
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. |
| 12 months from study entry |
| Time to Peak Plasma Concentration (Tmax) of Tivozanib in a Subset of Subjects | 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. | 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 |
| Maximum Observed Serum Concentration During a Dosing Interval at Steady State (Cmax) | 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. | 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 |
| Area Under the Serum Concentration Versus Time Curve From Zero to the Last Quantifiable Sampling Point [AUC(0→24)] | 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. | 28 weeks from study entry |
| Kolkata |
| India |
| Mumbai | India |
| New Delhi | India |
| Pune | India |
| Astrakhan | Russia |
| Kazan' | Russia |
| Moscow | 125284 | Russia |
| Moscow | 129128 | Russia |
| Moscow | Russia |
| Obninsk | Russia |
| Pyatigorsk | Russia |
| Rostove-on-Don | Russia |
| Saint Petersburg | Russia |
| Sochi | Russia |
| Tomsk | Russia |
| Ufa | Russia |
| Veliky Novgorod | Russia |
| Yoshkar-Ola | Russia |
| Cherkassy | Ukraine |
| Dnipro | Ukraine |
| Donetsk | Ukraine |
| Kharkiv | Ukraine |
| Lviv | Ukraine |
| Uzhhorod | Ukraine |
| Zaporizzhya | Ukraine |
| Double-blind Period: Tivozanib (AV-951) |
Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive 1.5 mg/ day of tivozanib for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner. |
| FG002 | Double-blind Period: Placebo | Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive matching placebo for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner. |
| COMPLETED |
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| NOT COMPLETED |
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| Double-Blind Period (12 Weeks) |
|
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| Maintenance Period |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Period:Tivozanib (AV-951) | Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off). After 16 weeks (4 cycles), disease status was assessed and compared to baseline. Tivozanib was to be discontinued following disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) | To determine the safety and tolerability of tivozanib (AV-951) with the protocol-specified dose schedule | Posted | Count of Participants | Participants | 28 weeks after study entry |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Objective Response [Complete Response (CR) + Partial Response (PR)] Rate at 16 Week Open-Label Period (All Treated Population) | 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. | Posted | Count of Participants | Participants | 16 weeks after study entry |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Randomly Assigned Subjects Remaining Progression Free at 12 Weeks Following Random Assignment to Tivozanib (AV-951) or Placebo | 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. | Posted | Count of Participants | Participants | 28 weeks after study entry |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Progression Free-survival (PFS) After Random Assignment (Randomized Sub-set Only) (at 12 Weeks Post Randomization ) | 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. | Posted | Count of Participants | Participants | 28 weeks from study entry |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Progression-free Survival (From Start of Treatment) | 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. | Posted | Count of Participants | Participants | 12 months from study entry |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Peak Plasma Concentration (Tmax) of Tivozanib in a Subset of Subjects | 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. | 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. | Posted | Mean | Standard Deviation | hours | 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 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration During a Dosing Interval at Steady State (Cmax) | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration Versus Time Curve From Zero to the Last Quantifiable Sampling Point [AUC(0→24)] | 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. | 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. | Posted | Mean | Standard Deviation | h*ng/mL | 28 weeks from study entry |
|
|
1 year
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety (SAF) Population was reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Period: Tivozanib (AV-951) | Subjects were enrolled into the initial, 16-week, open-label period and received tivozanib at a dose of 1.5 mg/day (oral administration). Subjects received tivozanib continuously for 3 weeks followed by 1 week off study drug (1 cycle = 3 weeks on, 1 week off). | 16 | 272 | 215 | 272 | ||
| EG001 | Double-blind Period: Tivozanib (AV-951) | Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive 1.5 mg/ day of tivozanib for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner. | 2 | 61 | 31 | 61 | ||
| EG002 | Double-blind Period: Placebo | Subjects with < 25% tumor change (growth or shrinkage) at the end of the 16-week open-label period were randomly assigned to receive matching placebo for 12 weeks (3 cycles; 1 cycle = 3 weeks on, 1 week off) in a double-blind manner. | 3 | 57 | 32 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Metatstatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gamma-glutamyl transferase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Combined Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment | Includes hypertension, blood pressure increased, essential hypertension, and hypertensive crisis |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | AVEO Pharmaceuticals, Inc. | 857-400-0101 | Clinical@aveooncology.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C553176 | tivozanib |
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| Unknown or Not Reported |
|
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| Grade 3 or higher adverse events |
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| Treatment-related adverse events |
|
| Discontinuations due to adverse events |
|
| Deaths |
|
|
|
| OG003 | Independent Radiology Reviewer (Placebo) | All assessment were performed by the study Investigator and similarly for IRR. |
|
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| Units | Counts |
|---|---|
| Participants |
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All assessment were performed by the study Investigator and similarly for IRR. |
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