Trial Outcomes & Findings for A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients (NCT NCT00263211)
NCT ID: NCT00263211
Last Updated: 2017-03-15
Results Overview
Measured by number of patients who have detectable circulating tumor cells
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Week 4
Results posted on
2017-03-15
Participant Flow
This study opened for enrollment in January 6, 2006 and closed enrollment in May 25, 2010
Participant milestones
| Measure |
Plavix and Aspirin
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
Observation by treating physician
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Plavix and Aspirin
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
Observation by treating physician
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
Baseline Characteristics
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Plavix and Aspirin
n=24 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 Participants
Observation by treating physician
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
55.79 years
STANDARD_DEVIATION 12.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline
|
12 participants
n=5 Participants
|
18 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 Positivity (HER2+)
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Estrogen Receptor Positivity (ER+)
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Number of Metastatic Sites
1
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Number of Metastatic Sites
2
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Number of Metastatic Sites
≥3
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Number of Previous Metastatic Chemotherapy Regimens
0
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Number of Previous Metastatic Chemotherapy Regimens
1
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Number of Previous Metastatic Chemotherapy Regimens
2
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Number of Previous Metastatic Chemotherapy Regimens
≥3
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Number of Previous Metastatic Endocrine Therapies
0
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Number of Previous Metastatic Endocrine Therapies
1
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Number of Previous Metastatic Endocrine Therapies
≥2
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Number of Participants Concurrently using Trastuzumab
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Number of Participants Concurrently using Bisphosphonate
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Number of Participants who Smoke
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Plavix \& Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.
Measured by number of patients who have detectable circulating tumor cells
Outcome measures
| Measure |
Plavix and Aspirin
n=19 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=23 Participants
Observation by treating physician
|
|---|---|---|
|
Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
|
11 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Maximum of 6 monthsPopulation: Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting
Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.
Outcome measures
| Measure |
Plavix and Aspirin
n=22 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 Participants
Observation by treating physician
|
|---|---|---|
|
Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
Bleeding (possibly related)
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
Back pain (unlikely related)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 1 monthPopulation: Denominator for Plavix \& Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23
Percent of patients with a given number/range of CTCs ( 0, 1-5 \>+ 5) vs. time baseline 2-weeks and 1 month for plavix \& Aspirin arm and observation only
Outcome measures
| Measure |
Plavix and Aspirin
n=22 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 Participants
Observation by treating physician
|
|---|---|---|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Baseline 0 CTCs
|
40.00 percentage of participants
|
22.73 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
2 week 0 CTCs
|
45.00 percentage of participants
|
40.00 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
1 month 0 CTCs
|
41.18 percentage of participants
|
35.00 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Baseline 1-5 CTCs
|
45.00 percentage of participants
|
63.64 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
2 weeks 1-5 CTCs
|
31.58 percentage of participants
|
45.00 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
1 month 1-5 CTCs
|
52.94 percentage of participants
|
55.00 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Baseline >=5 CTS
|
15.00 percentage of participants
|
13.64 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
2 weeks >=5 CTCs
|
21.05 percentage of participants
|
15.00 percentage of participants
|
|
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
1 month >=5 CTCs
|
5.88 percentage of participants
|
10.00 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 1 monthPopulation: Denominator for Plavix \& Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23
Mean platelet inhibition vs. time plotted for Plavix \& Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).
Outcome measures
| Measure |
Plavix and Aspirin
n=22 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 Participants
Observation by treating physician
|
|---|---|---|
|
Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
Baseline Aspirin Reaction UnitsARU
|
610.39 Aspirin Reaction Units
Standard Deviation 57.64
|
579.81 Aspirin Reaction Units
Standard Deviation 92.10
|
|
Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
2 weeks ARU
|
435.33 Aspirin Reaction Units
Standard Deviation 56.50
|
578.35 Aspirin Reaction Units
Standard Deviation 151.10
|
|
Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
1 month ARU
|
455.44 Aspirin Reaction Units
Standard Deviation 94.70
|
593.58 Aspirin Reaction Units
Standard Deviation 88.81
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 1 monthPopulation: Mean Platelet inhibition Denominator for Plavix \& Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23
Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups
Outcome measures
| Measure |
Plavix and Aspirin
n=22 Participants
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 Participants
Observation by treating physician
|
|---|---|---|
|
Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
Baseline
|
9.85 percentage of platelet inhibition
Standard Deviation 16.13
|
13.00 percentage of platelet inhibition
Standard Deviation 21.93
|
|
Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
2 weeks
|
37.35 percentage of platelet inhibition
Standard Deviation 30.38
|
9.05 percentage of platelet inhibition
Standard Deviation 7.96
|
|
Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
1 month
|
35.56 percentage of platelet inhibition
Standard Deviation 30.90
|
7.05 percentage of platelet inhibition
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Maximum of 6 monthsPopulation: This trial was terminated early due to futility, subjects were not followed for progression free-survival.
Outcome measures
Outcome data not reported
Adverse Events
Plavix and Aspirin
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Observation Only
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plavix and Aspirin
n=24 participants at risk
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 participants at risk
Observation by treating physician
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24
|
4.2%
1/24
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/24
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Edema
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Calf Pain
|
4.2%
1/24
|
0.00%
0/24
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24
|
4.2%
1/24
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Mucositis
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Esophagitis
|
4.2%
1/24
|
0.00%
0/24
|
Other adverse events
| Measure |
Plavix and Aspirin
n=24 participants at risk
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
|
Observation Only
n=24 participants at risk
Observation by treating physician
|
|---|---|---|
|
Investigations
ALT
|
16.7%
4/24
|
0.00%
0/24
|
|
Investigations
AST
|
4.2%
1/24
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Albumin, serum low
|
0.00%
0/24
|
4.2%
1/24
|
|
Investigations
Alkaline Phosphate
|
8.3%
2/24
|
8.3%
2/24
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
2/24
|
8.3%
2/24
|
|
Injury, poisoning and procedural complications
Bruising
|
37.5%
9/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Colitis
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
16.7%
4/24
|
16.7%
4/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
6/24
|
25.0%
6/24
|
|
Vascular disorders
Lymphedema
|
0.00%
0/24
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Dermatology other-Pruritus
|
8.3%
2/24
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Dermatology other-bilateral breast inflammation and discoloration and alopecia
|
0.00%
0/24
|
8.3%
2/24
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24
|
8.3%
2/24
|
|
Nervous system disorders
Dizziness
|
25.0%
6/24
|
25.0%
6/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24
|
8.3%
2/24
|
|
General disorders
Edema: Limb
|
20.8%
5/24
|
20.8%
5/24
|
|
General disorders
Edema Head and Neck
|
0.00%
0/24
|
4.2%
1/24
|
|
General disorders
Edema Trunk/genital
|
0.00%
0/24
|
4.2%
1/24
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/24
|
4.2%
1/24
|
|
General disorders
Fatigue
|
33.3%
8/24
|
33.3%
8/24
|
|
General disorders
Fever
|
4.2%
1/24
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/24
|
4.2%
1/24
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
3/24
|
12.5%
3/24
|
|
Vascular disorders
Hematoma
|
4.2%
1/24
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Hemoglobin
|
29.2%
7/24
|
29.2%
7/24
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage Respiratory Nose
|
8.3%
2/24
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Hemorrhage, GU Vagina
|
4.2%
1/24
|
0.00%
0/24
|
|
Vascular disorders
Hot Flashes
|
16.7%
4/24
|
16.7%
4/24
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/24
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
6/24
|
25.0%
6/24
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/24
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/24
|
8.3%
2/24
|
|
Vascular disorders
Hypertension
|
4.2%
1/24
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/24
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
3/24
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.2%
1/24
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/24
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/24
|
4.2%
1/24
|
|
Vascular disorders
Hypotension
|
4.2%
1/24
|
0.00%
0/24
|
|
Infections and infestations
Infection G 1/2 Normal ANC Pulmonary (Neck NOS)
|
4.2%
1/24
|
0.00%
0/24
|
|
Infections and infestations
Infection G 1/2 Normal Pulmonary (upper airway)
|
0.00%
0/24
|
4.2%
1/24
|
|
Infections and infestations
Infection Unknown ANC Auditory /ear (external)
|
4.2%
1/24
|
0.00%
0/24
|
|
Infections and infestations
Infection Unknown ANC Pulmonary (Pharynx)
|
0.00%
0/24
|
4.2%
1/24
|
|
Infections and infestations
Infection Unknown ANC Renal (Urinary tract)
|
4.2%
1/24
|
0.00%
0/24
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24
|
12.5%
3/24
|
|
Musculoskeletal and connective tissue disorders
Joint -function
|
4.2%
1/24
|
0.00%
0/24
|
|
Investigations
Leukocytes
|
25.0%
6/24
|
25.0%
6/24
|
|
General disorders
Lymphatic other swelling
|
0.00%
0/24
|
4.2%
1/24
|
|
Investigations
Lymphopenia
|
20.8%
5/24
|
20.8%
5/24
|
|
Metabolism and nutrition disorders
Metabolic Lab/ Other BUN high
|
0.00%
0/24
|
12.5%
3/24
|
|
Metabolism and nutrition disorders
Plasma protein low
|
12.5%
3/24
|
0.00%
0/24
|
|
Psychiatric disorders
Mood Alteration-Anxiety
|
0.00%
0/24
|
4.2%
1/24
|
|
Gastrointestinal disorders
Nausea
|
33.3%
8/24
|
37.5%
9/24
|
|
Nervous system disorders
Neuropathy -cranial motor face
|
0.00%
0/24
|
4.2%
1/24
|
|
Nervous system disorders
Neuropathy -motor
|
4.2%
1/24
|
0.00%
0/24
|
|
Nervous system disorders
Neuropathy Sensory
|
25.0%
6/24
|
25.0%
6/24
|
|
Investigations
Neutrophils
|
12.5%
3/24
|
12.5%
3/24
|
|
Investigations
PTT
|
0.00%
0/24
|
8.3%
2/24
|
|
Nervous system disorders
Pain Neuralgia/Neuropathy
|
0.00%
0/24
|
8.3%
2/24
|
|
Gastrointestinal disorders
Pain GI (Abdomen NOS)
|
8.3%
2/24
|
8.3%
2/24
|
|
Gastrointestinal disorders
Pain GI (stomach)
|
0.00%
0/24
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
4/24
|
16.7%
4/24
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/24
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
20.8%
5/24
|
20.8%
5/24
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
8.3%
2/24
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/24
|
4.2%
1/24
|
|
Nervous system disorders
Headache
|
33.3%
8/24
|
33.3%
8/24
|
|
Musculoskeletal and connective tissue disorders
Hip and Jaw Pain
|
8.3%
2/24
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Pain Pulmonary (Chest Thorax NOS)
|
0.00%
0/24
|
4.2%
1/24
|
|
Investigations
Platelets
|
4.2%
1/24
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash acne/acneiforme
|
4.2%
1/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash dermatitis assoc. with reaction : chemo
|
4.2%
1/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
0.00%
0/24
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Rash erythema multiforme
|
0.00%
0/24
|
4.2%
1/24
|
|
Renal and urinary disorders
Renal (Slight blood in urine/hematuria)
|
8.3%
2/24
|
0.00%
0/24
|
|
General disorders
Rigors/chills
|
0.00%
0/24
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Persistent vaginal herpes
|
4.2%
1/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown decubitus ulcer
|
4.2%
1/24
|
0.00%
0/24
|
|
General disorders
Sweating
|
0.00%
0/24
|
12.5%
3/24
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
1/24
|
0.00%
0/24
|
|
Renal and urinary disorders
Urine color change
|
8.3%
2/24
|
8.3%
2/24
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24
|
16.7%
4/24
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/24
|
12.5%
3/24
|
|
Gastrointestinal disorders
Liver Pain
|
0.00%
0/24
|
4.2%
1/24
|
Additional Information
Katherine Weilbacher, M.D,
Department of Medicine Div. of Oncology, Washington University School of Medicine St. Louis MO
Phone: Fax: 314-454-8973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place