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Trial record 13 of 15 for:    Trebananib | Recruiting, Active, not recruiting, Completed Studies | Cancer | Phase 2

Amgen 386 for Recurrent Glioblastoma

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: NCT01290263
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : May 25, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
David Reardon, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Drug: Amgen 386
Drug: Bevacizumab
Enrollment 48
Recruitment Details As of August 1, 2013, Cohort A was closed to new accrual following early interim analysis of first 10 participants enrolled on study showed insufficient efficacy per design.
Pre-assignment Details  
Arm/Group Title Cohort A: AMG 386 30 mg/kg Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab All Cohort B Participants: AMG 386 + Bevacizumab
Hide Arm/Group Description Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity. Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg.

Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity. Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 11 3 7 27 37
Completed 0 0 0 0 0
Not Completed 11 3 7 27 37
Reason Not Completed
Adverse Event             0             0             0             1             1
Lack of Efficacy             8             2             7             24             33
Withdrawal by Subject             3             1             0             1             2
Participant Non-Compliance             0             0             0             1             1
Arm/Group Title Cohort B: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg Total
Hide Arm/Group Description All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity. All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 37 11 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 11 participants 48 participants
63
(37 to 86)
62
(29 to 78)
62
(29 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 11 participants 48 participants
Female
11
  29.7%
5
  45.5%
16
  33.3%
Male
26
  70.3%
6
  54.5%
32
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 11 participants 48 participants
Hispanic or Latino
0
   0.0%
1
   9.1%
1
   2.1%
Not Hispanic or Latino
35
  94.6%
10
  90.9%
45
  93.8%
Unknown or Not Reported
2
   5.4%
0
   0.0%
2
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 11 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
35
  94.6%
10
  90.9%
45
  93.8%
More than one race
1
   2.7%
1
   9.1%
2
   4.2%
Unknown or Not Reported
1
   2.7%
0
   0.0%
1
   2.1%
Number of Prior Relapses  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 11 participants 48 participants
1 23 8 31
2 14 2 16
3 0 1 1
1.Primary Outcome
Title 6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]
Hide Description PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Cohort B Participants: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Hide Arm/Group Description:
All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.243
(0.12 to 0.38)
0
(0 to 0)
2.Primary Outcome
Title AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]
Hide Description The MTD of weekly AMG 386 intravenously (IV) in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Time Frame Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All phase I Cohort B participants who received at least one dose of the study drug were evaluable for MTD. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.
Arm/Group Title Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab
Hide Arm/Group Description:
Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg.

Overall Number of Participants Analyzed 3 7
Measure Type: Number
Unit of Measure: mg/kg intravenously on days 1 and 15
30 30
3.Primary Outcome
Title AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]
Hide Description A DLT is defined as an adverse event that (a) is related to the AMG 386 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 28 days of the study treatment, and (c) meets any of the following criteria: >= grade 3 thrombocytopenia; grade 4 neutropenia lasting > 7 days; grade 4 anemia lasting > 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5x10^9/L; clinically significant grade 3 non-hematologic toxicity despite maximal medical therapy lasting > 7 days, with the exception of grade 3 proteinuria which was considered a DLT if lasting > 14 days; grade 3 non-hematologic toxicity resulting in study drug discontinuation; grade 4 non-hematologic toxicity; >= grade 1 new CNS hemorrhage; >= grade 2 non-CNS hemorrhage.
Time Frame Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All phase I Cohort B participants who completed 28 days on study treatment were evaluable. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.
Arm/Group Title Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab
Hide Arm/Group Description:
Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg.

Overall Number of Participants Analyzed 3 7
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Best Radiographic Response [Cohort A and Cohort B]
Hide Description Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD, stable non-enhancing lesions, and stable clinically.
Time Frame Disease was assessed radiographically for response every 8 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were evaluable for response.
Arm/Group Title All Cohort B Participants: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Hide Arm/Group Description:
All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 11
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0
Partial Response 4 0
Stable Disease 20 1
Progressive Disease 10 8
Unknown 3 2
5.Secondary Outcome
Title Overall Survival (OS) [Cohort A and Cohort B]
Hide Description OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.
Time Frame Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were followed for OS.
Arm/Group Title All Cohort B Participants: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Hide Arm/Group Description:
All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 11
Median (Full Range)
Unit of Measure: days
285
(225 to 442)
341
(138 to 554)
6.Secondary Outcome
Title Progression-Free Survival (PFS) [Cohort A and Cohort B]
Hide Description PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Time Frame Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug were evaluable for PFS.
Arm/Group Title All Cohort B Participants: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Hide Arm/Group Description:
All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 11
Median (Full Range)
Unit of Measure: days
108
(56 to 166)
21
(5 to 36)
Time Frame Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
 
Arm/Group Title Cohort B: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Hide Arm/Group Description All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity. All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
All-Cause Mortality
Cohort B: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort B: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/37 (13.51%)      0/11 (0.00%)    
Blood and lymphatic system disorders     
Platelet count decreased  1 [1]  1/37 (2.70%)  1 0/11 (0.00%)  0
General disorders     
Edema Limbs  1 [2]  1/37 (2.70%)  1 0/11 (0.00%)  0
Fatigue  1 [3]  1/37 (2.70%)  1 0/11 (0.00%)  0
Fatigue  1 [4]  1/37 (2.70%)  1 0/11 (0.00%)  0
Investigations     
Neutrophil Count Decreased  1 [5]  1/37 (2.70%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv4
[1]
Grade 4 Platelet count decreased
[2]
Grade 3 Edema Limbs
[3]
Grade 3 Fatigue
[4]
Grade 2 Fatigue
[5]
Grade 4 Neutrophil Count Decreased
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort B: AMG 386 + Bevacizumab Cohort A: AMG 386 30 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/37 (81.08%)      8/11 (72.73%)    
Blood and lymphatic system disorders     
Anemia  1 [1]  2/37 (5.41%)  2 0/11 (0.00%)  0
Cardiac disorders     
Atrial Flutter  1 [2]  1/37 (2.70%)  1 0/11 (0.00%)  0
Pericardial Effusion  1 [3]  1/37 (2.70%)  1 0/11 (0.00%)  0
Eye disorders     
Blurred Vision  1 [4]  0/37 (0.00%)  0 1/11 (9.09%)  1
Blurred Vision  1 [5]  1/37 (2.70%)  1 0/11 (0.00%)  0
Other - Conjunctival Hemorrhage  1 [6]  1/37 (2.70%)  1 0/11 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1 [7]  1/37 (2.70%)  1 1/11 (9.09%)  1
Abdominal Pain  1 [8]  0/37 (0.00%)  0 1/11 (9.09%)  1
Constipation  1 [9]  0/37 (0.00%)  0 2/11 (18.18%)  2
Constipation  1 [10]  1/37 (2.70%)  1 0/11 (0.00%)  0
Diarrhea  1 [11]  0/37 (0.00%)  0 1/11 (9.09%)  1
Diarrhea  1 [12]  1/37 (2.70%)  1 0/11 (0.00%)  0
Dry Mouth  1 [13]  0/37 (0.00%)  0 1/11 (9.09%)  1
Hemorrhoids  1 [14]  1/37 (2.70%)  1 0/11 (0.00%)  0
Nausea  1 [15]  3/37 (8.11%)  3 2/11 (18.18%)  2
Stomach Pain  1 [16]  1/37 (2.70%)  1 0/11 (0.00%)  0
Other - Indigestion/heartburn  1 [17]  0/37 (0.00%)  0 1/11 (9.09%)  1
General disorders     
Edema Face  1 [18]  1/37 (2.70%)  1 0/11 (0.00%)  0
Edema Limbs  1 [19]  3/37 (8.11%)  3 1/11 (9.09%)  1
Edema Limbs  1 [20]  2/37 (5.41%)  2 0/11 (0.00%)  0
Fatigue  1 [21]  3/37 (8.11%)  3 0/11 (0.00%)  0
Fatigue  1 [22]  3/37 (8.11%)  3 2/11 (18.18%)  2
Infusion Related Reaction  1 [23]  1/37 (2.70%)  1 0/11 (0.00%)  0
Infusion Site Reaction  1 [24]  1/37 (2.70%)  1 0/11 (0.00%)  0
Localized Edema  1 [25]  1/37 (2.70%)  1 0/11 (0.00%)  0
Gait Disturbance  1 [26]  0/37 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications     
Bruising  1 [27]  1/37 (2.70%)  1 0/11 (0.00%)  0
Vascular Access Complication  1 [28]  1/37 (2.70%)  1 0/11 (0.00%)  0
Investigations     
Alanine Aminotransferase Increased  1 [29]  2/37 (5.41%)  2 0/11 (0.00%)  0
Alkaline Phosphatase Increased  1 [30]  1/37 (2.70%)  1 0/11 (0.00%)  0
Aspartate Aminotransferase Increased  1 [31]  2/37 (5.41%)  2 0/11 (0.00%)  0
Blood Bilirubin Increased  1 [32]  1/37 (2.70%)  1 0/11 (0.00%)  0
Cardiac Troponin I Increased  1 [33]  1/37 (2.70%)  1 0/11 (0.00%)  0
Neutrophil Count Decreased  1 [34]  1/37 (2.70%)  1 0/11 (0.00%)  0
Neutrophil Count Decreased  1 [35]  1/37 (2.70%)  1 0/11 (0.00%)  0
Platelet Count Decreased  1 [36]  4/37 (10.81%)  4 0/11 (0.00%)  0
Platelet Count Decreased  1 [37]  1/37 (2.70%)  1 0/11 (0.00%)  0
White Blood Cell Decreased  1 [38]  1/37 (2.70%)  1 0/11 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1 [39]  1/37 (2.70%)  1 0/11 (0.00%)  0
Hyperglycemia  1 [40]  2/37 (5.41%)  2 0/11 (0.00%)  0
Hypokalemia  1 [41]  2/37 (5.41%)  2 0/11 (0.00%)  0
Hyponatremia  1 [42]  2/37 (5.41%)  2 1/11 (9.09%)  1
Hypophosphatemia  1 [43]  1/37 (2.70%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1 [44]  2/37 (5.41%)  2 0/11 (0.00%)  0
Generalized Muscle Weakness  1 [45]  1/37 (2.70%)  1 1/11 (9.09%)  1
Muscle Weakness Lower Limb  1 [46]  0/37 (0.00%)  0 1/11 (9.09%)  1
Myalgia  1 [47]  1/37 (2.70%)  1 0/11 (0.00%)  0
Nervous system disorders     
Dizziness  1 [48]  1/37 (2.70%)  1 0/11 (0.00%)  0
Headache  1 [49]  2/37 (5.41%)  2 1/11 (9.09%)  1
Intracranial Hemorrhage  1 [50]  1/37 (2.70%)  1 0/11 (0.00%)  0
Presyncope  1 [51]  1/37 (2.70%)  1 0/11 (0.00%)  0
Psychiatric disorders     
Confusion  1 [52]  1/37 (2.70%)  1 0/11 (0.00%)  0
Insomnia  1 [53]  1/37 (2.70%)  1 0/11 (0.00%)  0
Insomnia  1 [54]  0/37 (0.00%)  0 1/11 (9.09%)  1
Renal and urinary disorders     
Hematuria  1 [55]  3/37 (8.11%)  3 0/11 (0.00%)  0
Proteinuria  1 [56]  1/37 (2.70%)  1 0/11 (0.00%)  0
Proteinuria  1 [57]  1/37 (2.70%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1 [58]  3/37 (8.11%)  3 0/11 (0.00%)  0
Hoarseness  1 [59]  6/37 (16.22%)  6 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1 [60]  2/37 (5.41%)  2 0/11 (0.00%)  0
Rash Maculo-papular  1 [61]  1/37 (2.70%)  1 0/11 (0.00%)  0
Skin Ulceration  1 [62]  1/37 (2.70%)  1 0/11 (0.00%)  0
Other - Livedo Reticularis  1 [63]  1/37 (2.70%)  1 0/11 (0.00%)  0
Vascular disorders     
Hypertension  1 [64]  2/37 (5.41%)  2 0/11 (0.00%)  0
Hypertension  1 [65]  10/37 (27.03%)  10 0/11 (0.00%)  0
Hypertension  1 [66]  3/37 (8.11%)  3 0/11 (0.00%)  0
Thromboembolic Event  1 [67]  2/37 (5.41%)  2 0/11 (0.00%)  0
Thromboembolic Event  1 [68]  1/37 (2.70%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv4
[1]
Grade 2 Anemia
[2]
Grade 2 Atrial Flutter
[3]
Grade 2 Pericardial Effusion
[4]
Grade 1 Blurred Vision
[5]
Grade 2 Blurred Vision
[6]
Grade 1 Other - Conjunctival Hemorrhage
[7]
Grade 1 Abdominal Pain
[8]
Grade 2 Abdominal Pain
[9]
Grade 1 Constipation
[10]
Grade 2 Constipation
[11]
Grade 1 Diarrhea
[12]
Grade 2 Diarrhea
[13]
Grade 1 Dry Mouth
[14]
Grade 1 Hemorrhoids
[15]
Grade 1 Nausea
[16]
Grade 1 Stomach Pain
[17]
Grade 2 Other - Indigestion/heartburn
[18]
Grade 1 Edema Face
[19]
Grade 1 Edema Limbs
[20]
Grade 2 Edema Limbs
[21]
Grade 1 Fatigue
[22]
Grade 2 Fatigue
[23]
Grade 2 Infusion Related Reaction
[24]
Grade 1 Infusion Site Reaction
[25]
Grade 2 Localized Edema
[26]
Grade 1 Gait Disturbance
[27]
Grade 1 Bruising
[28]
Grade 2 Vascular Access Complication
[29]
Grade 1 Alanine Aminotransferase Increased
[30]
Grade 1 Alkaline Phosphatase Increased
[31]
Grade 1 Aspartate Aminotransferase Increased
[32]
Grade 1 Blood Bilirubin Increased
[33]
Grade 3 Cardiac Troponin I Increased
[34]
Grade 1 Neutrophil Count Decreased
[35]
Grade 2 Neutrophil Count Decreased
[36]
Grade 1 Platelet Count Decreased
[37]
Grade 4 Platelet Count Decreased
[38]
Grade 1 White Blood Cell Decreased
[39]
Grade 1 Anorexia
[40]
Grade 1 Hyperglycemia
[41]
Grade 1 Hypokalemia
[42]
Grade 1 Hyponatremia
[43]
Grade 3 Hypophosphatemia
[44]
Grade 1 Arthralgia
[45]
Grade 1 Generalized Muscle Weakness
[46]
Grade 2 Muscle Weakness Lower Limb
[47]
Grade 1 Myalgia
[48]
Grade 1 Dizziness
[49]
Grade 1 Headache
[50]
Grade 1 Intracranial Hemorrhage
[51]
Grade 1 Presyncope
[52]
Grade 1 Confusion
[53]
Grade 1 Insomnia
[54]
Grade 2 Insomnia
[55]
Grade 1 Hematuria
[56]
Grade 1 Proteinuria
[57]
Grade 2 Proteinuria
[58]
Grade 1 Epistaxis
[59]
Grade 1 Hoarseness
[60]
Grade 1 Alopecia
[61]
Grade 1 Rash Maculo-papular
[62]
Grade 1 Skin Ulceration
[63]
Grade 1 Other - Livedo Reticularis
[64]
Grade 1 Hypertension
[65]
Grade 2 Hypertension
[66]
Grade 3 Hypertension
[67]
Grade 2 Thromboembolic Event
[68]
Grade 3 Thromboembolic Event
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
Name/Title: David A. Reardon, MD
Organization: Dana-Farber Cancer Institute
Phone: 617-632-2166
Responsible Party: David Reardon, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01290263     History of Changes
Other Study ID Numbers: 12-185
First Submitted: January 9, 2011
First Posted: February 4, 2011
Results First Submitted: January 17, 2017
Results First Posted: May 25, 2017
Last Update Posted: July 2, 2017