Trial Outcomes & Findings for Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage (NCT NCT00589290)
NCT ID: NCT00589290
Last Updated: 2015-09-30
Results Overview
Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
25.5 months
Results posted on
2015-09-30
Participant Flow
This study plans to accrue 1.85 patients per month. The expected accrual is 41 patients (25 thymoma and 16 thymic).
Participant milestones
| Measure |
Belinostat Treatment
1000 mg/m\^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Belinostat Treatment
1000 mg/m\^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage
Baseline characteristics by cohort
| Measure |
Belinostat Treatment
n=41 Participants
1000 mg/m\^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
54.53 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25.5 monthsResponse is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.
Outcome measures
| Measure |
Thymoma Patients
n=25 Participants
Well differentiated neoplasm
|
Thymic Patients
n=16 Participants
Poorly differentiated neoplasm
|
|---|---|---|
|
Number of Participants With a Partial Response
|
2 Participants
Interval 2.3 to 25.9
|
0 Participants
Interval 0.0 to 19.4
|
PRIMARY outcome
Timeframe: 46 monthsPopulation: Unpublished data from Dr. Giaccone's lab does not reveal an association between these parameters and outcomes in patients with thymic malignancies. Hence we do not plan to perform analyses for these outcome measures and there is no known negative clinical implications associated with this.
Utilize a patients tumor tissue to determine if there is any correlation between chromosomal gains or losses in comparative genomic hybridization in thymoma and thymic carcinomas and clinical outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 monthsHere are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Thymoma Patients
n=41 Participants
Well differentiated neoplasm
|
Thymic Patients
Poorly differentiated neoplasm
|
|---|---|---|
|
Number of Participants With Adverse Events
|
41 Participants
|
—
|
Adverse Events
Belinostat Treatment
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belinostat Treatment
n=41 participants at risk
1000 mg/m\^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Infections and infestations-Other, specify infection with normal ANC or Gr 1 or 2 neutrophils:Blood
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Dysphasia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
Other adverse events
| Measure |
Belinostat Treatment
n=41 participants at risk
1000 mg/m\^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
22.0%
9/41 • Number of events 17 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
56.1%
23/41 • Number of events 55 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.2%
5/41 • Number of events 5 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.2%
5/41 • Number of events 9 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.2%
5/41 • Number of events 12 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.7%
13/41 • Number of events 18 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
26.8%
11/41 • Number of events 18 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
5/41 • Number of events 5 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Blood and lymphatic system disorders
Anemia
|
65.9%
27/41 • Number of events 54 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Cardiac disorders
Sinus tachycardia
|
14.6%
6/41 • Number of events 8 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
11/41 • Number of events 14 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Diarrhea
|
14.6%
6/41 • Number of events 7 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Nausea
|
56.1%
23/41 • Number of events 61 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Gastrointestinal disorders
Vomiting
|
31.7%
13/41 • Number of events 22 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Chills
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Edema face
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Edema limbs
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Fatigue
|
36.6%
15/41 • Number of events 21 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Fever
|
22.0%
9/41 • Number of events 12 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Injection site reaction
|
7.3%
3/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Immune system disorders
Allergic reaction
|
19.5%
8/41 • Number of events 10 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Bronchial infection
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Eye infection
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Infections and infestations-Other, specify
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Mucosal infection
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Nail infection
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Sinusitis
|
9.8%
4/41 • Number of events 5 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Upper respiratory infection
|
17.1%
7/41 • Number of events 7 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
26.8%
11/41 • Number of events 15 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Alanine aminotransferase increased
|
19.5%
8/41 • Number of events 10 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Alkaline phosphatase increased
|
19.5%
8/41 • Number of events 11 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Blood bilirubin increased
|
19.5%
8/41 • Number of events 14 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
CPK increased
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Creatinine increased
|
12.2%
5/41 • Number of events 6 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
51.2%
21/41 • Number of events 77 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Lipase increased
|
2.4%
1/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Lymphocyte count decreased
|
48.8%
20/41 • Number of events 92 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Lymphocyte count increased
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Neutrophil count decreased
|
12.2%
5/41 • Number of events 13 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Platelet count decreased
|
14.6%
6/41 • Number of events 31 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Serum amylase increased
|
2.4%
1/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Weight gain
|
7.3%
3/41 • Number of events 7 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Weight loss
|
14.6%
6/41 • Number of events 6 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
White blood cell decreased
|
34.1%
14/41 • Number of events 33 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.8%
11/41 • Number of events 17 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
17.1%
7/41 • Number of events 13 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.8%
4/41 • Number of events 4 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.3%
3/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
5/41 • Number of events 6 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Ataxia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Number of events 7 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Dysgeusia
|
4.9%
2/41 • Number of events 2 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Dysphasia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Memory impairment
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • Number of events 5 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Peripheral sendory neuropathy
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Nervous system disorders
Syncope
|
7.3%
3/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Psychiatric disorders
Anxiety
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Psychiatric disorders
Depression
|
4.9%
2/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Reproductive system and breast disorders
Breast pain
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.3%
3/41 • Number of events 7 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulomonary hemorrhage
|
2.4%
1/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
8/41 • Number of events 10 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.5%
8/41 • Number of events 14 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
3/41 • Number of events 3 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.8%
4/41 • Number of events 4 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.8%
4/41 • Number of events 5 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Flushing
|
7.3%
3/41 • Number of events 4 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Number of events 4 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Hypotension
|
22.0%
9/41 • Number of events 11 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Phlebitis
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Number of events 1 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
|
Investigations
Aspartate aminotransferase increased
|
31.7%
13/41 • Number of events 18 • 2 years, 2 months
CTCAE v3.0 from beginning of study through 12/31/10; CTCAE v4.0 beginning 1/1/11.
|
Additional Information
Arun Rajan, M.D.
National Institutes of Health (NIH), National Cancer Institute (NCI)
Phone: 301-594-5322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place