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A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

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ClinicalTrials.gov Identifier: NCT01030783
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Renal Cell Carcinoma
Interventions Drug: tivozanib (AV-951)
Drug: Sorafenib
Enrollment 517
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Period Title: Overall Study
Started 260 257
Completed 211 231
Not Completed 49 26
Arm/Group Title Tivozanib (AV-951) Sorafenib Total
Hide Arm/Group Description tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 260 257 517
Hide Baseline Analysis Population Description
All randomized subjects
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 260 participants 257 participants 517 participants
59
(23 to 83)
59
(23 to 85)
59
(23 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 257 participants 517 participants
Female
75
  28.8%
68
  26.5%
143
  27.7%
Male
185
  71.2%
189
  73.5%
374
  72.3%
1.Primary Outcome
Title Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib
Hide Description Progression-Free Survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.0 criteria is defined 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.
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 260 257
Median (95% Confidence Interval)
Unit of Measure: Months
11.9
(9.3 to 14.7)
9.1
(7.3 to 9.5)
2.Secondary Outcome
Title Overall Survival (OS) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Hide Description Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive. Subjects lacking data beyond randomization will have their survival times censored on the date of randomization.
Time Frame Date of randomization to date of death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 260 257
Median (95% Confidence Interval)
Unit of Measure: Months
28.2
(22.5 to 33.0)
30.8
(28.4 to 33.3)
3.Secondary Outcome
Title Objective Response Rate (ORR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Hide Description Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.0).
Time Frame Every 8 weeks from date of randomization until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 260 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.1
(27.4 to 39.2)
23.3
(18.3 to 29.0)
4.Secondary Outcome
Title Duration of Response (DR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Hide Description Duration of response (DR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.0 or to death due to any cause.
Time Frame Assessed every 8 weeks from date of randomization until date of progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 86 58
Median (95% Confidence Interval)
Unit of Measure: Months
15.0 [1] 
(12.9 to NA)
12.9 [1] 
(11.0 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event.
5.Secondary Outcome
Title Safety and Tolerability of Tivozanib and Sorafenib
Hide Description Dose reductions and interruptions were allowed for subjects taking tivozanib or sorafenib. Any modification of study drug administration, and the reason for such action, was clearly noted on the subject's eCRF.
Time Frame From start of treatment therapy to completion of treatment therapy, an average of 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 259 257
Measure Type: Count of Participants
Unit of Measure: Participants
Reasons for Dose Interruptions - Adverse Event
50
  19.3%
92
  35.8%
Reasons for Dose Reductions - Adverse Event
36
  13.9%
111
  43.2%
6.Secondary Outcome
Title To Compare Kidney-specific Symptoms and Health Outcome Measurements in Subjects Randomized to Treatment With Tivozanib or Sorafenib
Hide Description The Disease Related Symptom Scale of the Functional Assessment of Cancer Therapy - Advanced Kidney Cancer Symptom Index (FKSI-DRS) measured kidney specific symptoms on a 0-36 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The Functional Assessment of Cancer Therapy-General (FACT-G) measured general wellbeing scored on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The European Quality of Life-5 Dimensions (EQ-5D) measured patient health related quality of life scored on a 0-1 scale, with 0 being worse health state and 1 being perfect health state. The European Quality of Life-5 Dimensions Visual Analog Scales (EQ-5D VAS) measured patient health related quality of life on a visual analog scale from 0 to 100, with 0 being the worst and 100 being the best. These scales were self-administered by patients at the start of the visit.
Time Frame At Day 1 of each 28 day cycle throughout the course of the study, for an average of 11 months per subject
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, excluding questionnaires that were not analyzable
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 257 250
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
FACT-G Total Score Number Analyzed 257 participants 248 participants
74.16  (0.785) 73.05  (0.802)
FKSI-DRS Score Number Analyzed 256 participants 248 participants
28.71  (0.227) 28.58  (0.233)
EQ-5D Weighted Health State Index Number Analyzed 256 participants 250 participants
0.67  (0.014) 0.66  (0.014)
EQ-5D VAS Number Analyzed 257 participants 250 participants
71.50  (0.826) 68.49  (0.841)
7.Secondary Outcome
Title Pharmacokinetics (Serum Concentrations) of Tivozanib
Hide Description Samples for tivozanib serum concentrations will be collected at the following time points: Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28. The serum concentrations of tivozanib were tabulated for individual subjects and summarized by nominal time using standard descriptive statistics (concentrations presented in ng/mL).
Time Frame Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had taken at least 1 dose of tivozanib and who had at least one measurable concentration value.
Arm/Group Title Tivozanib (AV-951)
Hide Arm/Group Description:
tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Overall Number of Participants Analyzed 254
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Cycle 1, Day 1 Number Analyzed 249 participants
0
(0.0 to 0.0)
Cycle 1, Day 15 Number Analyzed 250 participants
69.05
(65.0 to 73.1)
Cycle 2, Day 1 Number Analyzed 254 participants
30.87
(28.0 to 33.7)
Cycle 2, Day 22-28 Number Analyzed 244 participants
54.37
(49.8 to 59.0)
Time Frame From first dose to last dose plus 30 days, approximately 1 year on average
Adverse Event Reporting Description Safety Population
 
Arm/Group Title Tivozanib (AV-951) Sorafenib
Hide Arm/Group Description tivozanib (AV-951): Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. Sorafenib: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
All-Cause Mortality
Tivozanib (AV-951) Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tivozanib (AV-951) Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   74/259 (28.57%)   56/257 (21.79%) 
Blood and lymphatic system disorders     
Anaemia  4/259 (1.54%)  4/257 (1.56%) 
Thrombocytopenia  1/259 (0.39%)  0/257 (0.00%) 
Neutropenia  0/259 (0.00%)  1/257 (0.39%) 
Polycythaemia  0/259 (0.00%)  1/257 (0.39%) 
Cardiac disorders     
Acute myocardial infarction  2/259 (0.77%)  2/257 (0.78%) 
Myocardial infarction  2/259 (0.77%)  4/257 (1.56%) 
Arteriosclerosis coronary artery  1/259 (0.39%)  1/257 (0.39%) 
Cardiac arrest  1/259 (0.39%)  0/257 (0.00%) 
Cardiac failure acute  1/259 (0.39%)  1/257 (0.39%) 
Cardiopulmonary failure  1/259 (0.39%)  0/257 (0.00%) 
Angina unstable  0/259 (0.00%)  1/257 (0.39%) 
Cardiac failure  0/259 (0.00%)  1/257 (0.39%) 
Coronary artery insufficiency  0/259 (0.00%)  1/257 (0.39%) 
Left ventricular dysfunction  0/259 (0.00%)  1/257 (0.39%) 
Myocardial ischaemia  0/259 (0.00%)  1/257 (0.39%) 
Sick sinus syndrome  0/259 (0.00%)  1/257 (0.39%) 
Endocrine disorders     
Hyperthyroidism  1/259 (0.39%)  0/257 (0.00%) 
Hypothyroidism  1/259 (0.39%)  0/257 (0.00%) 
Eye disorders     
Cataract  1/259 (0.39%)  0/257 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  2/259 (0.77%)  0/257 (0.00%) 
Constipation  0/259 (0.00%)  2/257 (0.78%) 
Haemorrhoidal haemorrhage  1/259 (0.39%)  0/257 (0.00%) 
Intestinal obstruction  1/259 (0.39%)  1/257 (0.39%) 
Pancreatitis acute  1/259 (0.39%)  1/257 (0.39%) 
Periproctitis  1/259 (0.39%)  0/257 (0.00%) 
Small intestinal haemorrhage  1/259 (0.39%)  0/257 (0.00%) 
Vomiting  1/259 (0.39%)  0/257 (0.00%) 
Gastric ulcer  0/259 (0.00%)  1/257 (0.39%) 
Large intestine perforation  0/259 (0.00%)  1/257 (0.39%) 
Nausea  0/259 (0.00%)  1/257 (0.39%) 
Salivary gland mass  0/259 (0.00%)  1/257 (0.39%) 
Haematemesis  1/259 (0.39%)  0/257 (0.00%) 
General disorders     
Fatigue  3/259 (1.16%)  1/257 (0.39%) 
Death  2/259 (0.77%)  0/257 (0.00%) 
Pyrexia  2/259 (0.77%)  0/257 (0.00%) 
Non-cardiac chest pain  1/259 (0.39%)  1/257 (0.39%) 
Hepatobiliary disorders     
Cholecystitis acute  0/259 (0.00%)  3/257 (1.17%) 
Bile duct stone  1/259 (0.39%)  0/257 (0.00%) 
Cholelithiasis  0/259 (0.00%)  1/257 (0.39%) 
Jaundice  0/259 (0.00%)  1/257 (0.39%) 
Infections and infestations     
Pneumonia  1/259 (0.39%)  3/257 (1.17%) 
Abdominal abscess  1/259 (0.39%)  0/257 (0.00%) 
Abscess soft tissue  1/259 (0.39%)  0/257 (0.00%) 
Parotitis  1/259 (0.39%)  0/257 (0.00%) 
Pneumonia viral  1/259 (0.39%)  0/257 (0.00%) 
Urinary tract infection  1/259 (0.39%)  1/257 (0.39%) 
Device related infection  0/259 (0.00%)  1/257 (0.39%) 
Diverticulitis  0/259 (0.00%)  1/257 (0.39%) 
Gastroenteritis  0/259 (0.00%)  1/257 (0.39%) 
Lung abscess  0/259 (0.00%)  1/257 (0.39%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1/259 (0.39%)  0/257 (0.00%) 
Overdose  1/259 (0.39%)  0/257 (0.00%) 
Ankle fracture  0/259 (0.00%)  1/257 (0.39%) 
Femur fracture  0/259 (0.00%)  1/257 (0.39%) 
Post procedural haemorrhage  0/259 (0.00%)  1/257 (0.39%) 
Investigations     
Amylase increased  1/259 (0.39%)  0/257 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia  1/259 (0.39%)  0/257 (0.00%) 
Cachexia  0/259 (0.00%)  1/257 (0.39%) 
Musculoskeletal and connective tissue disorders     
Pathological fracture  2/259 (0.77%)  0/257 (0.00%) 
Bone pain  0/259 (0.00%)  2/257 (0.78%) 
Muscular weakness  1/259 (0.39%)  0/257 (0.00%) 
Back pain  0/259 (0.00%)  1/257 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression  9/259 (3.47%)  2/257 (0.78%) 
Hepatic neoplasm malignant  1/259 (0.39%)  0/257 (0.00%) 
Malignant urinary tract neoplasm  1/259 (0.39%)  0/257 (0.00%) 
Metastases to central nervous system  1/259 (0.39%)  1/257 (0.39%) 
Metastatic pain  1/259 (0.39%)  0/257 (0.00%) 
Renal cancer  1/259 (0.39%)  0/257 (0.00%) 
Metastases to ovary  0/259 (0.00%)  1/257 (0.39%) 
Squamous cell carcinoma  0/259 (0.00%)  1/257 (0.39%) 
Nervous system disorders     
Cerebrovascular accident  4/259 (1.54%)  3/257 (1.17%) 
Ischaemic stroke  3/259 (1.16%)  0/257 (0.00%) 
Transient ischaemic attack  2/259 (0.77%)  0/257 (0.00%) 
Cerebral ischaemia  1/259 (0.39%)  0/257 (0.00%) 
Coma  1/259 (0.39%)  0/257 (0.00%) 
Encephalopathy  1/259 (0.39%)  0/257 (0.00%) 
Grand mal convulsion  1/259 (0.39%)  1/257 (0.39%) 
Haemorrhage intracranial  1/259 (0.39%)  0/257 (0.00%) 
Haemorrhagic stroke  1/259 (0.39%)  0/257 (0.00%) 
Hemiparesis  1/259 (0.39%)  0/257 (0.00%) 
Loss of consciousness  1/259 (0.39%)  0/257 (0.00%) 
Metabolic encephalopathy  1/259 (0.39%)  0/257 (0.00%) 
Spinal cord compression  1/259 (0.39%)  0/257 (0.00%) 
Renal and urinary disorders     
Calculus ureteric  1/259 (0.39%)  0/257 (0.00%) 
Renal failure  1/259 (0.39%)  0/257 (0.00%) 
Renal failure acute  1/259 (0.39%)  1/257 (0.39%) 
Renal failure chronic  1/259 (0.39%)  0/257 (0.00%) 
Urinary retention  1/259 (0.39%)  0/257 (0.00%) 
Renal colic  0/259 (0.00%)  1/257 (0.39%) 
Reproductive system and breast disorders     
Pelvic fluid collection  1/259 (0.39%)  0/257 (0.00%) 
Postmenopausal haemorrhage  1/259 (0.39%)  0/257 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  3/259 (1.16%)  2/257 (0.78%) 
Dyspnoea  2/259 (0.77%)  3/257 (1.17%) 
Pulmonary oedema  2/259 (0.77%)  0/257 (0.00%) 
Epistaxis  0/259 (0.00%)  2/257 (0.78%) 
Pleural effusion  0/259 (0.00%)  4/257 (1.56%) 
Pleurisy  0/259 (0.00%)  2/257 (0.78%) 
Acute respiratory distress syndrome  0/259 (0.00%)  1/257 (0.39%) 
Pulmonary artery thrombosis  0/259 (0.00%)  1/257 (0.39%) 
Respiratory failure  0/259 (0.00%)  1/257 (0.39%) 
Skin and subcutaneous tissue disorders     
Dermatitis bullous  1/259 (0.39%)  0/257 (0.00%) 
Skin exfoliation  0/259 (0.00%)  1/257 (0.39%) 
Vascular disorders     
Hypertension  3/259 (1.16%)  2/257 (0.78%) 
Aortic aneurysm rupture  1/259 (0.39%)  0/257 (0.00%) 
Hypertensive crisis  1/259 (0.39%)  0/257 (0.00%) 
Peripheral ischaemia  0/259 (0.00%)  1/257 (0.39%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tivozanib (AV-951) Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   238/259 (91.89%)   249/257 (96.89%) 
Blood and lymphatic system disorders     
Anaemia  15/259 (5.79%)  15/257 (5.84%) 
Endocrine disorders     
Hypothyroidism  14/259 (5.41%)  5/257 (1.95%) 
Gastrointestinal disorders     
Diarrhoea  63/259 (24.32%)  85/257 (33.07%) 
Nausea  34/259 (13.13%)  19/257 (7.39%) 
Stomatitis  30/259 (11.58%)  23/257 (8.95%) 
Vomiting  20/259 (7.72%)  12/257 (4.67%) 
Abdominal pain upper  18/259 (6.95%)  17/257 (6.61%) 
Abdominal pain  16/259 (6.18%)  10/257 (3.89%) 
Constipation  12/259 (4.63%)  13/257 (5.06%) 
General disorders     
Fatigue  53/259 (20.46%)  41/257 (15.95%) 
Asthenia  44/259 (16.99%)  44/257 (17.12%) 
Pyrexia  11/259 (4.25%)  13/257 (5.06%) 
Investigations     
Weight decreased  49/259 (18.92%)  54/257 (21.01%) 
Blood thyroid stimulating hormone increased  14/259 (5.41%)  6/257 (2.33%) 
Lipase increased  12/259 (4.63%)  24/257 (9.34%) 
Blood phosphorus decreased  5/259 (1.93%)  16/257 (6.23%) 
Metabolism and nutrition disorders     
Decreased appetite  28/259 (10.81%)  24/257 (9.34%) 
Musculoskeletal and connective tissue disorders     
Back pain  38/259 (14.67%)  21/257 (8.17%) 
Arthralgia  19/259 (7.34%)  11/257 (4.28%) 
Pain in extremity  14/259 (5.41%)  6/257 (2.33%) 
Nervous system disorders     
Headache  23/259 (8.88%)  11/257 (4.28%) 
Renal and urinary disorders     
Proteinuria  24/259 (9.27%)  21/257 (8.17%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  55/259 (21.24%)  12/257 (4.67%) 
Dyspnoea  31/259 (11.97%)  22/257 (8.56%) 
Cough  23/259 (8.88%)  18/257 (7.00%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  36/259 (13.90%)  139/257 (54.09%) 
Alopecia  6/259 (2.32%)  55/257 (21.40%) 
Rash erythematous  6/259 (2.32%)  16/257 (6.23%) 
Dry skin  5/259 (1.93%)  13/257 (5.06%) 
Rash papular  3/259 (1.16%)  16/257 (6.23%) 
Vascular disorders     
Hypertension  116/259 (44.79%)  91/257 (35.41%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: AVEO Pharmaceuticals, Inc.
Phone: 617-588-1960
EMail: Clinical@aveooncology.com
Layout table for additonal information
Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01030783    
Other Study ID Numbers: AV-951-09-301
First Submitted: December 9, 2009
First Posted: December 11, 2009
Results First Submitted: April 30, 2019
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019