Not provided
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Sponsor
Not provided
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
Not provided
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Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).
This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/QoL.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tivozanib Hydrochloride | Experimental | 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks. |
|
| Sunitinib | Active Comparator | 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tivozanib | Drug |
|
| |
| Sunitinib |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With AEs and SAEs | Number of subjects with serious and non-serious adverse events. | Up to 25 weeks |
| Number of Subjects With Dose Reductions | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Needle, MD | AVEO Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90001 | United States | |||
Not provided
| Label | URL |
|---|---|
| Aveo Pharmaceuticals, Inc. official web page | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All screening assessments were performed within 28 days prior to the first dose of study drug. All subjects were recruited as per the inclusion and exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tivozanib First, Then Sunitinib | Subject randomized to this arm received 1.5 mg oral tivozanib hydrochloride (drug 1) daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib (drug 2) daily on a 4 weeks on/2 weeks off schedule for 12 weeks. |
| FG001 | Sunitinib First, Then Tivosanib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Up to 25 weeks |
| Number of Subjects With Dose Interruptions | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Number of Subjects With Grade 3/4 Hematology Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Number of Subjects With Grade 3/4 Chemistry Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Number of Subjects With Grade 3/4 Coagulation Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Number of Subjects With Grade 3/4 Urinalysis Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Number of Subjects With Grade 3/4 Thyroid Function Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Up to 25 weeks |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
| Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
| Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
| Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
| Albany |
| Georgia |
| 31701 |
| United States |
| Atlanta | Georgia | 30301 | United States |
| Chicago | Illinois | 60007 | United States |
| Indianapolis | Indiana | 46077 | United States |
| Shreveport | Louisiana | 71101 | United States |
| Worcester | Massachusetts | 01601 | United States |
| Minneapolis | Minnesota | 55111 | United States |
| New York | New York | 10001 | United States |
| Columbus | Ohio | 43004 | United States |
| Portland | Oregon | 97035 | United States |
| Charleston | South Carolina | 29401 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| San Antonio | Texas | 78006 | United States |
| Madison | Wisconsin | 53558 | United States |
| Antwerp | Belgium |
| Brussels | Belgium |
| Bordeaux | France |
| Caen | France |
| Lyon | France |
| Paris | France |
| Berlin | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Heidelberg | Germany |
| Munich | Germany |
| Aviano | Italy |
| Pavia | Italy |
| Rome | Italy |
| Barcelona | Spain |
| Madrid | Spain |
| Pamplona | Spain |
| Valencia | Spain |
| Glasgow | Scotland | United Kingdom |
| Swansea | Wales | United Kingdom |
| Cambridge | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
Subject randomized to this arm received 50 mg oral sunitinib (drug 1) daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride (drug 2) daily on a 3 weeks on/1 week off schedule for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects randomized to Arm 1, received 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule for 12 weeks (3 cycles) followed by 50 mg oral sunitinib daily on a 4 week on/2 week off schedule for 12 weeks (2 cycles). Subjects randomized to Arm 2, received 50 mg oral sunitinib daily on a 4 week on/2 weeks off schedule for 12 weeks followed by 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule. |
| 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 | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With AEs and SAEs | Number of subjects with serious and non-serious adverse events. | Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events). | Posted | Count of Participants | Participants | Up to 25 weeks |
|
| ||||||||||||||||||||
| Secondary | Number of Subjects With Dose Reductions | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Dose Interruptions | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Grade 3/4 Hematology Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Grade 3/4 Chemistry Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Grade 3/4 Coagulation Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Grade 3/4 Urinalysis Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Number of Subjects With Grade 3/4 Thyroid Function Abnormalities | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Up to 25 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure. | Posted | Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment |
|
|
Collected from the time of signing the Informed Consent Form until 30 days after permanent treatment discontinuation at Week 25 (2 sequential 12-week treatment periods with a 1-week washout period). The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.
Serious treatment-emergent adverse events and treatment-emergent adverse events in Safety (SAF) Population was reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tivozanib | Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2. | 6 | 38 | 35 | 38 | ||
| EG001 | Sunitinib | Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1. | 7 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C553176 | tivozanib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|