Trial Outcomes & Findings for Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies (NCT NCT00241358)
NCT ID: NCT00241358
Last Updated: 2017-06-06
Results Overview
-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Day 1-3
Results posted on
2017-06-06
Participant Flow
The study was opened to participant enrollment on 05/14/2004 and closed to participant enrollment on 01/26/2009.
Participant milestones
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
46
|
21
|
|
Overall Study
COMPLETED
|
25
|
45
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Overall Study
Determined to be not ineligible
|
0
|
1
|
1
|
Baseline Characteristics
Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
n=25 Participants
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
n=46 Participants
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
n=21 Participants
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
53 years
n=7 Participants
|
51 years
n=5 Participants
|
52 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
46 participants
n=7 Participants
|
21 participants
n=5 Participants
|
92 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1-3-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
n=25 Participants
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
n=20 Participants
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)
|
22 Participants
|
—
|
19 Participants
|
PRIMARY outcome
Timeframe: By Day 100 after transplantPopulation: Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
n=38 Participants
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)
|
—
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: Day +21Population: Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
n=38 Participants
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
|
—
|
37 Participants
|
—
|
SECONDARY outcome
Timeframe: Between Day +100 and +365 post-transplantPopulation: Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.
-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
n=28 Participants
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)
|
—
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 100 days after transplantPopulation: Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
n=38 Participants
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
|
—
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 48-72 hours after last dose of AMD3100Population: -Quality of life questionnaires were not collected from the recipients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)-Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
n=25 Participants
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
n=20 Participants
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
Proportion of Donors Who Experience Infusional Toxicity (Donor Only)
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 24 hours after dose of IV AMD3100Population: Pharmacokinetics were not performed on 2 patients who were considered replacement patients.
-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
n=19 Participants
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax
|
—
|
—
|
1058 ng/ml
Interval 214.0 to 2150.0
|
SECONDARY outcome
Timeframe: 0 to 24 hours after dose of IV AMD3100Population: Pharmacokinetics were not performed on 2 patients who were considered replacement patients.
-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
Outcome measures
| Measure |
Subcutaneous (SC) Treatment Plan - Donor
* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
Recipients
* Conditioning Regimen
* Cyclophosphamide 60mg/kg/day on Days -3 and -2
* TBI 550cGy on Day -1
* GVHD prophylaxis
\*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
|
Intravenous (IV) Treatment Plan - Donor
n=19 Participants
* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
|
|---|---|---|---|
|
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity
|
—
|
—
|
5150 ng*hr/mL
Interval 1243.0 to 11019.0
|
Adverse Events
Donors
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Recipients
Serious events: 12 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donors
n=46 participants at risk
AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
|
Recipients
n=46 participants at risk
Stem Cell Transplantation Day 0
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46
|
4.3%
2/46
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/46
|
4.3%
2/46
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/46
|
2.2%
1/46
|
|
Infections and infestations
C. Difficile infection
|
0.00%
0/46
|
2.2%
1/46
|
|
Nervous system disorders
Confusion
|
0.00%
0/46
|
4.3%
2/46
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Death due to disease progression
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/46
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/46
|
4.3%
2/46
|
|
General disorders
Edema - extremities
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/46
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Erythemous rash
|
0.00%
0/46
|
2.2%
1/46
|
|
Eye disorders
Eye pain
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Fever
|
2.2%
1/46
|
4.3%
2/46
|
|
General disorders
Generalized weakness
|
0.00%
0/46
|
2.2%
1/46
|
|
Nervous system disorders
Headache
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Vascular disorders
Hypotension
|
0.00%
0/46
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/46
|
2.2%
1/46
|
|
Investigations
Increased bilirubin
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Increased creatinine
|
0.00%
0/46
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Iron deficiency
|
2.2%
1/46
|
0.00%
0/46
|
|
Gastrointestinal disorders
Mouth pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46
|
6.5%
3/46
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46
|
0.00%
0/46
|
|
Investigations
Pancytopenia
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/46
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/46
|
6.5%
3/46
|
|
Infections and infestations
Sepsis
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.2%
1/46
|
0.00%
0/46
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/46
|
2.2%
1/46
|
|
Nervous system disorders
Vasovagal reaction
|
2.2%
1/46
|
0.00%
0/46
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46
|
4.3%
2/46
|
|
Investigations
Weight loss
|
0.00%
0/46
|
4.3%
2/46
|
Other adverse events
| Measure |
Donors
n=46 participants at risk
AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
|
Recipients
n=46 participants at risk
Stem Cell Transplantation Day 0
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46
|
8.7%
4/46
|
|
General disorders
Anasarca
|
0.00%
0/46
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/46
|
15.2%
7/46
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/46
|
6.5%
3/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/46
|
8.7%
4/46
|
|
Infections and infestations
Bacteremia
|
0.00%
0/46
|
6.5%
3/46
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/46
|
4.3%
2/46
|
|
Cardiac disorders
Bradycardia
|
6.5%
3/46
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
0.00%
0/46
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.2%
1/46
|
2.2%
1/46
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Chills
|
6.5%
3/46
|
0.00%
0/46
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Cold sensation
|
4.3%
2/46
|
0.00%
0/46
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/46
|
13.0%
6/46
|
|
Psychiatric disorders
Confusion
|
0.00%
0/46
|
4.3%
2/46
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46
|
15.2%
7/46
|
|
Gastrointestinal disorders
Cramping
|
6.5%
3/46
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
10/46
|
34.8%
16/46
|
|
Gastrointestinal disorders
Distension/abdominal bloating
|
8.7%
4/46
|
4.3%
2/46
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46
|
4.3%
2/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/46
|
4.3%
2/46
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Edema/larynx
|
0.00%
0/46
|
2.2%
1/46
|
|
Nervous system disorders
Extrapyramidal involuntary movement
|
4.3%
2/46
|
6.5%
3/46
|
|
Musculoskeletal and connective tissue disorders
Extremity walking (gait/walking)
|
0.00%
0/46
|
6.5%
3/46
|
|
General disorders
Facial edema (head and neck)
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Fatigue
|
8.7%
4/46
|
37.0%
17/46
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/46
|
41.3%
19/46
|
|
Nervous system disorders
Feet tremor
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Fever
|
0.00%
0/46
|
13.0%
6/46
|
|
Gastrointestinal disorders
Fistula, GI
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Flatulence
|
17.4%
8/46
|
0.00%
0/46
|
|
Infections and infestations
Foliculitis
|
2.2%
1/46
|
6.5%
3/46
|
|
Infections and infestations
G-tube site infection
|
0.00%
0/46
|
2.2%
1/46
|
|
General disorders
Generalized weakness
|
0.00%
0/46
|
8.7%
4/46
|
|
Nervous system disorders
Hand tremor
|
0.00%
0/46
|
13.0%
6/46
|
|
Nervous system disorders
Headache
|
4.3%
2/46
|
15.2%
7/46
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptisis
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
2.2%
1/46
|
2.2%
1/46
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/46
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/46
|
10.9%
5/46
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/46
|
4.3%
2/46
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Vascular disorders
Hypertension
|
4.3%
2/46
|
4.3%
2/46
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/46
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/46
|
4.3%
2/46
|
|
Vascular disorders
Hypotension
|
6.5%
3/46
|
0.00%
0/46
|
|
General disorders
Hypothermia
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/46
|
4.3%
2/46
|
|
General disorders
Injection site reaction
|
19.6%
9/46
|
0.00%
0/46
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46
|
4.3%
2/46
|
|
Infections and infestations
Interstitial pneumonia
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.2%
1/46
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/46
|
4.3%
2/46
|
|
Nervous system disorders
Lightheadedness
|
28.3%
13/46
|
0.00%
0/46
|
|
General disorders
Lower extremities edema
|
0.00%
0/46
|
8.7%
4/46
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/46
|
4.3%
2/46
|
|
Psychiatric disorders
Mood alteration
|
2.2%
1/46
|
10.9%
5/46
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/46
|
39.1%
18/46
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46
|
34.8%
16/46
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46
|
0.00%
0/46
|
|
Cardiac disorders
Non-specific ST abnormality
|
2.2%
1/46
|
0.00%
0/46
|
|
Ear and labyrinth disorders
Otitis, middle ear
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal reactions
|
0.00%
0/46
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Petequiae
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/46
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.2%
1/46
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/46
|
30.4%
14/46
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/46
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/46
|
6.5%
3/46
|
|
Nervous system disorders
Seizure
|
0.00%
0/46
|
6.5%
3/46
|
|
Nervous system disorders
Sensory neuropathy
|
32.6%
15/46
|
6.5%
3/46
|
|
Musculoskeletal and connective tissue disorders
Shoulder blade pain
|
8.7%
4/46
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Infections and infestations
Sinusitis
|
2.2%
1/46
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Spine pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Nervous system disorders
Spine pain
|
2.2%
1/46
|
0.00%
0/46
|
|
General disorders
Sweating (diaphoresis)
|
10.9%
5/46
|
0.00%
0/46
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/46
|
10.9%
5/46
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/46
|
6.5%
3/46
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/46
|
2.2%
1/46
|
|
Vascular disorders
Thrombosis/embolism (DVT)
|
4.3%
2/46
|
6.5%
3/46
|
|
Cardiac disorders
U wave
|
2.2%
1/46
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/46
|
4.3%
2/46
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/46
|
4.3%
2/46
|
|
Renal and urinary disorders
Urinary color change
|
0.00%
0/46
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/46
|
6.5%
3/46
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46
|
8.7%
4/46
|
|
Cardiac disorders
Vasovagal episode
|
4.3%
2/46
|
0.00%
0/46
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/46
|
2.2%
1/46
|
|
Infections and infestations
Viremia
|
0.00%
0/46
|
6.5%
3/46
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/46
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46
|
34.8%
16/46
|
|
General disorders
Warm sensation
|
10.9%
5/46
|
0.00%
0/46
|
|
Eye disorders
Watery eye (tearing)
|
0.00%
0/46
|
4.3%
2/46
|
Additional Information
John F. DiPersio, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-454-8603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place