Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC (TAURUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673386
Recruitment Status : Terminated (Sponsor)
First Posted : August 28, 2012
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Metastatic Renal Cell Carcinoma
Interventions Drug: Tivozanib
Drug: Sunitinib
Enrollment 58
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Tivozanib First, Then Sunitinib Sunitinib First, Then Tivosanib
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 27 31
Completed 2 [1] 4 [2]
Not Completed 25 27
Reason Not Completed
Study terminated by sponsor             16             22
Adverse Event             5             2
Progressive disease             4             1
Withdrawal by Subject             0             2
[1]
Of 2 subjects, 1 subject discontinued tivozanib early, completed planned treatment with sunitinib.
[2]
Of 4 subjects, 3 subjects discontinued sunitinib early, completed planned treatment with tivozanib.
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  44.8%
>=65 years
32
  55.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants
65.5
(38 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
10
  17.2%
Male
48
  82.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.7%
White
56
  96.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Subjects With AEs and SAEs
Hide Description Number of subjects with serious and non-serious adverse events.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events).
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 38 41
Measure Type: Count of Participants
Unit of Measure: Participants
At least one AE
35
  92.1%
40
  97.6%
At least one treatment-related AE
33
  86.8%
38
  92.7%
At least one serious AE (SAE)
6
  15.8%
7
  17.1%
At least one treatment-related SAE
1
   2.6%
3
   7.3%
At least one AE leading to drug withdrawal
3
   7.9%
8
  19.5%
At least one AE with outcome of death
2
   5.3%
1
   2.4%
3.Secondary Outcome
Title Number of Subjects With Dose Reductions
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Subjects With Dose Interruptions
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Subjects With Grade 3/4 Hematology Abnormalities
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Subjects With Grade 3/4 Chemistry Abnormalities
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Subjects With Grade 3/4 Coagulation Abnormalities
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Subjects With Grade 3/4 Urinalysis Abnormalities
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
Hide Description The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Time Frame Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description:
Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.
Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description Serious treatment-emergent adverse events and treatment-emergent adverse events in Safety (SAF) Population was reported.
 
Arm/Group Title Tivozanib Sunitinib
Hide Arm/Group Description Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2. Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.
All-Cause Mortality
Tivozanib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tivozanib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   6/38 (15.79%)   7/41 (17.07%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/38 (0.00%)  1/41 (2.44%) 
Thrombocytopenia * 1  0/38 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders     
Nausea * 1  0/38 (0.00%)  2/41 (4.88%) 
Vomiting * 1  0/38 (0.00%)  2/41 (4.88%) 
Gastric ulcer haemorrhage * 1  0/38 (0.00%)  1/41 (2.44%) 
Rectal haemorrhage * 1  0/38 (0.00%)  1/41 (2.44%) 
Oesophagitis * 1  1/38 (2.63%)  0/41 (0.00%) 
General disorders     
Fatigue * 1  0/38 (0.00%)  1/41 (2.44%) 
Pyrexia * 1  0/38 (0.00%)  1/41 (2.44%) 
Asthenia * 1  2/38 (5.26%)  0/41 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  1/38 (2.63%)  0/41 (0.00%) 
Infections and infestations     
Subcutaneous abscess * 1  1/38 (2.63%)  0/41 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/38 (2.63%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders     
Flank pain * 1  1/38 (2.63%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain neoplasm * 1  0/38 (0.00%)  1/41 (2.44%) 
Neoplasm progression * 1  1/38 (2.63%)  0/41 (0.00%) 
Nervous system disorders     
Headache * 1  0/38 (0.00%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/38 (2.63%)  2/41 (4.88%) 
Pulmonary embolism * 1  1/38 (2.63%)  0/41 (0.00%) 
Atelectasis * 1  0/38 (0.00%)  1/41 (2.44%) 
Pleural effusion * 1  0/38 (0.00%)  1/41 (2.44%) 
Respiratory failure * 1  0/38 (0.00%)  1/41 (2.44%) 
Vascular disorders     
Hypotension * 1  0/38 (0.00%)  1/41 (2.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Tivozanib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   35/38 (92.11%)   40/41 (97.56%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/38 (2.63%)  4/41 (9.76%) 
Thrombocytopenia * 1  0/38 (0.00%)  6/41 (14.63%) 
Neutropenia * 1  0/38 (0.00%)  2/41 (4.88%) 
Eye disorders     
Eyelid oedema * 1  0/38 (0.00%)  3/41 (7.32%) 
Gastrointestinal disorders     
Diarrhoea * 1  17/38 (44.74%)  15/41 (36.59%) 
Stomatitis * 1  8/38 (21.05%)  9/41 (21.95%) 
Constipation * 1  5/38 (13.16%)  3/41 (7.32%) 
Gingival pain * 1  2/38 (5.26%)  0/41 (0.00%) 
Nausea * 1  5/38 (13.16%)  14/41 (34.15%) 
Vomiting * 1  3/38 (7.89%)  8/41 (19.51%) 
Abdominal pain upper * 1  2/38 (5.26%)  5/41 (12.20%) 
Dry mouth * 1  2/38 (5.26%)  2/41 (4.88%) 
Dyspepsia * 1  2/38 (5.26%)  10/41 (24.39%) 
Flatulence * 1  1/38 (2.63%)  5/41 (12.20%) 
Oral pain * 1  1/38 (2.63%)  2/41 (4.88%) 
Abdominal pain * 1  1/38 (2.63%)  3/41 (7.32%) 
Rectal haemorrhage * 1  0/38 (0.00%)  3/41 (7.32%) 
Gastrooesophageal reflux disease * 1  0/38 (0.00%)  2/41 (4.88%) 
Oral dysaesthesia * 1  0/38 (0.00%)  2/41 (4.88%) 
General disorders     
Fatigue * 1  14/38 (36.84%)  18/41 (43.90%) 
Asthenia * 1  7/38 (18.42%)  9/41 (21.95%) 
Oedema peripheral * 1  3/38 (7.89%)  5/41 (12.20%) 
Pyrexia * 1  2/38 (5.26%)  5/41 (12.20%) 
Chills * 1  0/38 (0.00%)  3/41 (7.32%) 
Hepatobiliary disorders     
Jaundice * 1  0/38 (0.00%)  4/41 (9.76%) 
Infections and infestations     
Nasopharyngitis * 1  2/38 (5.26%)  0/41 (0.00%) 
Tooth infection * 1  2/38 (5.26%)  1/41 (2.44%) 
Upper respiratory tract infection * 1  2/38 (5.26%)  0/41 (0.00%) 
Urinary tract infection * 1  2/38 (5.26%)  2/41 (4.88%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/38 (0.00%)  2/41 (4.88%) 
Investigations     
Weight decreased * 1  4/38 (10.53%)  0/41 (0.00%) 
Blood creatinine increased * 1  1/38 (2.63%)  3/41 (7.32%) 
Lipase increased * 1  0/38 (0.00%)  5/41 (12.20%) 
Amylase increased * 1  0/38 (0.00%)  3/41 (7.32%) 
Platelet count decreased * 1  0/38 (0.00%)  3/41 (7.32%) 
White blood cell count decreased * 1  0/38 (0.00%)  2/41 (4.88%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  7/38 (18.42%)  11/41 (26.83%) 
Dehydration * 1  2/38 (5.26%)  1/41 (2.44%) 
Hyponatraemia * 1  1/38 (2.63%)  2/41 (4.88%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  3/38 (7.89%)  2/41 (4.88%) 
Arthralgia * 1  2/38 (5.26%)  0/41 (0.00%) 
Back pain * 1  2/38 (5.26%)  6/41 (14.63%) 
Musculoskeletal pain * 1  2/38 (5.26%)  0/41 (0.00%) 
Musculoskeletal stiffness * 1  2/38 (5.26%)  0/41 (0.00%) 
Muscle spasms * 1  1/38 (2.63%)  2/41 (4.88%) 
Myalgia * 1  0/38 (0.00%)  4/41 (9.76%) 
Nervous system disorders     
Headache * 1  5/38 (13.16%)  1/41 (2.44%) 
Dysgeusia * 1  4/38 (10.53%)  17/41 (41.46%) 
Dizziness * 1  3/38 (7.89%)  3/41 (7.32%) 
Neuropathy peripheral * 1  0/38 (0.00%)  2/41 (4.88%) 
Paraesthesia * 1  1/38 (2.63%)  2/41 (4.88%) 
Psychiatric disorders     
Insomnia * 1  2/38 (5.26%)  1/41 (2.44%) 
Renal and urinary disorders     
Proteinuria * 1  1/38 (2.63%)  3/41 (7.32%) 
Haematuria * 1  1/38 (2.63%)  2/41 (4.88%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia * 1  14/38 (36.84%)  5/41 (12.20%) 
Dyspnoea * 1  5/38 (13.16%)  7/41 (17.07%) 
Cough * 1  6/38 (15.79%)  4/41 (9.76%) 
Oropharyngeal pain * 1  2/38 (5.26%)  0/41 (0.00%) 
Epistaxis * 1  0/38 (0.00%)  6/41 (14.63%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  7/38 (18.42%)  10/41 (24.39%) 
Pruritus * 1  3/38 (7.89%)  2/41 (4.88%) 
Rash * 1  3/38 (7.89%)  4/41 (9.76%) 
Hair colour changes * 1  1/38 (2.63%)  6/41 (14.63%) 
Yellow skin * 1  0/38 (0.00%)  4/41 (9.76%) 
Alopecia * 1  1/38 (2.63%)  3/41 (7.32%) 
Dry skin * 1  0/38 (0.00%)  3/41 (7.32%) 
Skin discolouration * 1  0/38 (0.00%)  3/41 (7.32%) 
Vascular disorders     
Hypertension * 1  19/38 (50.00%)  12/41 (29.27%) 
Hypotension * 1  3/38 (7.89%)  4/41 (9.76%) 
Deep vein thrombosis * 1  0/38 (0.00%)  2/41 (4.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.
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: 857-400-0101
EMail: Clinical@aveooncology.com
Layout table for additonal information
Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01673386    
Other Study ID Numbers: AV-951-12-205
First Submitted: August 23, 2012
First Posted: August 28, 2012
Results First Submitted: July 7, 2020
Results First Posted: October 27, 2020
Last Update Posted: October 27, 2020