Trial Outcomes & Findings for Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer (NCT NCT00179309)
NCT ID: NCT00179309
Last Updated: 2014-07-15
Results Overview
Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
19.7 months
Results posted on
2014-07-15
Participant Flow
Crossover was allowed so that patients randomized to B could receive the vaccine upon progression.
Participant milestones
| Measure |
Arm I - PANVAC + Docetaxel
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V: given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
Treatment
STARTED
|
25
|
23
|
|
Treatment
COMPLETED
|
21
|
18
|
|
Treatment
NOT COMPLETED
|
4
|
5
|
|
Crossover
STARTED
|
0
|
3
|
|
Crossover
COMPLETED
|
0
|
3
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I - PANVAC + Docetaxel
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V: given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
Treatment
Toxicity
|
2
|
3
|
|
Treatment
Withdrawal by Subject
|
1
|
2
|
|
Treatment
Allergy
|
1
|
0
|
Baseline Characteristics
Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I - PANVAC + Docetaxel
n=25 Participants
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
n=23 Participants
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Continuous
|
55.52 years
STANDARD_DEVIATION 10.52 • n=93 Participants
|
53.01 years
STANDARD_DEVIATION 12.22 • n=4 Participants
|
54.31 years
STANDARD_DEVIATION 11.21 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
23 participants
n=4 Participants
|
48 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 19.7 monthsTime between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.
Outcome measures
| Measure |
Arm I - PANVAC + Docetaxel
n=25 Participants
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
n=23 Participants
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6.6 Months
Interval 3.7 to 9.4
|
3.8 Months
Interval 2.6 to 8.4
|
SECONDARY outcome
Timeframe: 80 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Arm I - PANVAC + Docetaxel
n=25 Participants
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
n=23 Participants
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
23 Participants
|
23 Participants
|
Adverse Events
Arm I - PANVAC + Docetaxel
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm II - Docetaxel Alone
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - PANVAC + Docetaxel
n=25 participants at risk
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
n=23 participants at risk
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify -stomatitis)
|
0.00%
0/25
|
4.3%
1/23 • Number of events 2
|
|
Nervous system disorders
Nervous system disorders - Other, specify -neuropathy, hands and feet
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Vascular access complication
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Injection site reaction
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Delirium
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • Number of events 2
|
0.00%
0/23
|
Other adverse events
| Measure |
Arm I - PANVAC + Docetaxel
n=25 participants at risk
Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV
|
Arm II - Docetaxel Alone
n=23 participants at risk
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)
|
|---|---|---|
|
General disorders
Fatigue
|
64.0%
16/25 • Number of events 49
|
65.2%
15/23 • Number of events 29
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
5/25 • Number of events 10
|
17.4%
4/23 • Number of events 5
|
|
Investigations
Lymphocyte count decreased
|
44.0%
11/25 • Number of events 49
|
56.5%
13/23 • Number of events 41
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
68.0%
17/25 • Number of events 114
|
13.0%
3/23 • Number of events 7
|
|
Investigations
Alanine aminotransaminase increased
|
28.0%
7/25 • Number of events 15
|
39.1%
9/23 • Number of events 18
|
|
Investigations
Aspartate aminotransaminase increased
|
36.0%
9/25 • Number of events 25
|
39.1%
9/23 • Number of events 19
|
|
Investigations
Alkaline phosphatase increased
|
32.0%
8/25 • Number of events 14
|
17.4%
4/23 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.0%
4/25 • Number of events 4
|
17.4%
4/23 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
4.0%
1/25 • Number of events 2
|
17.4%
4/23 • Number of events 8
|
|
Investigations
CPK increased
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.0%
4/25 • Number of events 5
|
8.7%
2/23 • Number of events 6
|
|
Cardiac disorders
Cardiac disorders - Other, specify (tachycardia)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Cataract
|
8.0%
2/25 • Number of events 3
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Number of events 7
|
34.8%
8/23 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
6/25 • Number of events 10
|
21.7%
5/23 • Number of events 7
|
|
Investigations
Creatinine increased
|
12.0%
3/25 • Number of events 8
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dental caries
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
10/25 • Number of events 23
|
39.1%
9/23 • Number of events 27
|
|
Nervous system disorders
Dizziness
|
16.0%
4/25 • Number of events 16
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
2/25 • Number of events 3
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
8/25 • Number of events 21
|
17.4%
4/23 • Number of events 5
|
|
Blood and lymphatic system disorders
Edema face
|
12.0%
3/25 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema limbs
|
40.0%
10/25 • Number of events 13
|
8.7%
2/23 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
4.0%
1/25 • Number of events 3
|
0.00%
0/23
|
|
Eye disorders
Eyelid function disorder
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Fever
|
20.0%
5/25 • Number of events 5
|
26.1%
6/23 • Number of events 13
|
|
General disorders
Flu-like syndrome
|
12.0%
3/25 • Number of events 3
|
17.4%
4/23 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
48.0%
12/25 • Number of events 45
|
56.5%
13/23 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.0%
15/25 • Number of events 18
|
56.5%
13/23 • Number of events 13
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 5
|
13.0%
3/23 • Number of events 3
|
|
Renal and urinary disorders
Hemoglobinuria
|
8.0%
2/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (stomatitis)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Blurred vision
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/25
|
13.0%
3/23 • Number of events 8
|
|
Infections and infestations
Skin infection
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.0%
3/25 • Number of events 4
|
13.0%
3/23 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.0%
3/25 • Number of events 9
|
0.00%
0/23
|
|
Eye disorders
Dry eye
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • Number of events 7
|
8.7%
2/23 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/25
|
8.7%
2/23 • Number of events 3
|
|
Infections and infestations
Nail infection
|
4.0%
1/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
40.0%
10/25 • Number of events 16
|
30.4%
7/23 • Number of events 21
|
|
Investigations
Neutrophil count decreased
|
40.0%
10/25 • Number of events 39
|
26.1%
6/23 • Number of events 9
|
|
General disorders
Pain
|
24.0%
6/25 • Number of events 9
|
8.7%
2/23 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 2
|
13.0%
3/23 • Number of events 4
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Immune system disorders
Allergic reaction
|
12.0%
3/25 • Number of events 4
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Anemia
|
56.0%
14/25 • Number of events 56
|
43.5%
10/23 • Number of events 43
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • Number of events 6
|
13.0%
3/23 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 6
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify (hemoglobin, decreased)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
1/25 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Cholesterol high
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.0%
7/25 • Number of events 9
|
17.4%
4/23 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.0%
2/25 • Number of events 2
|
13.0%
3/23 • Number of events 9
|
|
Investigations
Platelet count decreased
|
16.0%
4/25 • Number of events 7
|
8.7%
2/23 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
16.0%
4/25 • Number of events 5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.0%
4/25 • Number of events 6
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 2
|
17.4%
4/23 • Number of events 6
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
5/25 • Number of events 8
|
17.4%
4/23 • Number of events 4
|
|
Psychiatric disorders
Psychosis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.0%
6/25 • Number of events 9
|
21.7%
5/23 • Number of events 12
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25 • Number of events 3
|
8.7%
2/23 • Number of events 4
|
|
Gastrointestinal disorders
Dysgeusia
|
32.0%
8/25 • Number of events 9
|
17.4%
4/23 • Number of events 6
|
|
Ear and labyrinth disorders
Tinnitus
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.0%
3/25 • Number of events 3
|
4.3%
1/23 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
8.0%
2/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25 • Number of events 12
|
17.4%
4/23 • Number of events 7
|
|
Eye disorders
Watering eyes
|
48.0%
12/25 • Number of events 15
|
39.1%
9/23 • Number of events 10
|
|
Investigations
Weight loss
|
4.0%
1/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.0%
4/25 • Number of events 8
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Eye disorders - Other, specify (eye disorder: twitch; eye tearing)
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/25
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
24.0%
6/25 • Number of events 7
|
17.4%
4/23 • Number of events 6
|
|
Gastrointestinal disorders
Gingival pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 15
|
13.0%
3/23 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
56.0%
14/25 • Number of events 48
|
43.5%
10/23 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Infusion site extravasation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Investigations - Other, specify (elevated LDH)
|
4.0%
1/25 • Number of events 7
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Metabolism and nutrition disorders - Other, specify
|
4.0%
1/25 • Number of events 5
|
0.00%
0/23
|
|
Investigations
CD4 lymphocytes decreased
|
4.0%
1/25 • Number of events 1
|
4.3%
1/23 • Number of events 4
|
|
Infections and infestations
Paronychia
|
4.0%
1/25 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify (surgical procedure, internal fixation)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Number of events 3
|
13.0%
3/23 • Number of events 4
|
|
Investigations
White blood cell decreased
|
40.0%
10/25 • Number of events 59
|
47.8%
11/23 • Number of events 23
|
|
Infections and infestations
Infections and infestations - Other, specify (left middle finger; port infection)
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
12.0%
3/25 • Number of events 4
|
13.0%
3/23 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
24.0%
6/25 • Number of events 6
|
21.7%
5/23 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Nervous system disorders - Other, specify-neuropathy; neuropathy: toes; Rt finger tip numbness)
|
20.0%
5/25 • Number of events 5
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
8.0%
2/25 • Number of events 3
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodysesthesia syndrome
|
4.0%
1/25 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Paresthesia
|
16.0%
4/25 • Number of events 5
|
21.7%
5/23 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.0%
7/25 • Number of events 14
|
26.1%
6/23 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
2/25 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.0%
6/25 • Number of events 8
|
13.0%
3/23 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
8.0%
2/25 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Tooth infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Vascular disorders - Other, specify (Rt side eye; subconj. hem)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25
|
4.3%
1/23 • Number of events 2
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify (anemia; hemoglobin decreased))
|
0.00%
0/25
|
13.0%
3/23 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Eye disorders - Other, specify (eye tearing; eye tearing, watery eyes; eye redness))
|
0.00%
0/25
|
13.0%
3/23 • Number of events 3
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/25
|
8.7%
2/23 • Number of events 3
|
|
Vascular disorders
Hot flashes
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/25
|
13.0%
3/23 • Number of events 6
|
|
Infections and infestations
Infections and infestations - Other, specify (upper respiratiry infection)
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/25
|
13.0%
3/23 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/25
|
13.0%
3/23 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify (dyspareunia)
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify (rhinorrhea)
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/25
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/25
|
8.7%
2/23 • Number of events 4
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/25
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Weight gain
|
0.00%
0/25
|
4.3%
1/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/25
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
8.0%
2/25 • Number of events 3
|
0.00%
0/23
|
Additional Information
Dr. James Gulley, M.D., Ph.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-2956
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place