Trial Outcomes & Findings for Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma (NCT NCT00245102)
NCT ID: NCT00245102
Last Updated: 2014-05-23
Results Overview
A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2014-05-23
Participant Flow
Protocol Open to Accrual 09/09/2005 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 03/22/2011 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Angiosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
MPNST
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Leiomyosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Undifferentiated Pleomorphic Sarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Fibrosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Other Histology
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
16
|
46
|
13
|
5
|
23
|
|
Overall Study
COMPLETED
|
37
|
12
|
39
|
10
|
5
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
7
|
3
|
0
|
4
|
Reasons for withdrawal
| Measure |
Angiosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
MPNST
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Leiomyosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Undifferentiated Pleomorphic Sarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Fibrosarcoma
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Other Histology
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
Not Treated
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
2
|
5
|
1
|
0
|
2
|
|
Overall Study
Decline in performance
|
0
|
2
|
0
|
1
|
0
|
2
|
|
Overall Study
Participant needed surgery
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Clinical progression
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
Baseline characteristics by cohort
| Measure |
Angiosarcoma
n=44 Participants
Sorafenib 400 mg PO BID
|
MPNST
n=16 Participants
Sorafenib 400 mg PO BID
|
Leiomyosarcoma
n=46 Participants
Sorafenib 400 mg PO BID
|
Undifferentiated Pleomorphic Sarcoma
n=13 Participants
Sorafenib 400 mg PO BID
|
Fibrosarcoma
n=5 Participants
Sorafenib 400 mg PO BID
|
Other Histology
n=23 Participants
Sorafenib 400 mg PO BID
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
103 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 50.91168825 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 34.64823228 • n=7 Participants
|
56 years
STANDARD_DEVIATION 33.9411255 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 31.81980515 • n=4 Participants
|
43.5 years
STANDARD_DEVIATION 10.60660172 • n=21 Participants
|
44 years
STANDARD_DEVIATION 31.11269837 • n=8 Participants
|
54 years
STANDARD_DEVIATION 50.91168825 • n=8 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
94 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
15 participants
n=7 Participants
|
46 participants
n=5 Participants
|
13 participants
n=4 Participants
|
5 participants
n=21 Participants
|
23 participants
n=8 Participants
|
146 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksA 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
Outcome measures
| Measure |
Angiosarcoma
n=37 Participants
Sorafenib 400 mg PO BID
|
MPNST
n=12 Participants
Sorafenib 400 mg PO BID
|
Leiomyosarcoma
n=39 Participants
Sorafenib 400 mg PO BID
|
Undifferentiated Pleomorphic Sarcoma
n=10 Participants
Sorafenib 400 mg PO BID
|
Fibrosarcoma
n=5 Participants
Sorafenib 400 mg PO BID
|
Other Histology
n=19 Participants
Sorafenib 400 mg PO BID
|
|---|---|---|---|---|---|---|
|
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
Partial Response
|
4 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
Complete Response
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Angiosarcoma
Serious events: 13 serious events
Other events: 36 other events
Deaths: 0 deaths
MPNST
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Leiomyosarcoma
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Undifferentiated Pleomorphic Sarcoma
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Fibrosarcoma
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Other Histology
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Angiosarcoma
n=44 participants at risk
Sorafenib 400 mg PO BID
|
MPNST
n=16 participants at risk
Sorafenib 400 mg PO BID
|
Leiomyosarcoma
n=46 participants at risk
Sorafenib 400 mg PO BID
|
Undifferentiated Pleomorphic Sarcoma
n=13 participants at risk
Sorafenib 400 mg PO BID
|
Fibrosarcoma
n=5 participants at risk
Sorafenib 400 mg PO BID
|
Other Histology
n=23 participants at risk
Sorafenib 400 mg PO BID
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.3%
1/44 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Cardiac disorders
Cardiac disorder
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Psychiatric disorders
Confusion
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
General disorders
Death-Disease progression
|
100.0%
1/1 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Lymphocyte count decreased
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
General disorders
Non-cardiac chest pain
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/44 • Number of events 1
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
General disorders
Fatigue
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/44
|
0.00%
0/16
|
4.3%
2/46 • Number of events 2
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Blood Bilirubin increased
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased (Anemia)
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Vascular disorders
Thrombosis
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/5
|
0.00%
0/23
|
|
Eye disorders
Vision-flashing lights
|
0.00%
0/44
|
0.00%
0/16
|
2.2%
1/46 • Number of events 1
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
General disorders
General symptom, other-Failure to thrive
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
General disorders
Death, NOS
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Respiratory tract (NOS)
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, bleeding other-Chest wall
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Infections and infestations
Bladder infection
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
Other adverse events
| Measure |
Angiosarcoma
n=44 participants at risk
Sorafenib 400 mg PO BID
|
MPNST
n=16 participants at risk
Sorafenib 400 mg PO BID
|
Leiomyosarcoma
n=46 participants at risk
Sorafenib 400 mg PO BID
|
Undifferentiated Pleomorphic Sarcoma
n=13 participants at risk
Sorafenib 400 mg PO BID
|
Fibrosarcoma
n=5 participants at risk
Sorafenib 400 mg PO BID
|
Other Histology
n=23 participants at risk
Sorafenib 400 mg PO BID
|
|---|---|---|---|---|---|---|
|
General disorders
Edema limbs
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
3/44 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
10.9%
5/46 • Number of events 5
|
15.4%
2/13 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
3/44 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.4%
5/44 • Number of events 5
|
31.2%
5/16 • Number of events 5
|
4.3%
2/46 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
4.5%
2/44 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44 • Number of events 3
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Fatigue
|
25.0%
11/44 • Number of events 11
|
0.00%
0/16
|
8.7%
4/46 • Number of events 4
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
17.4%
4/23 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.5%
2/44 • Number of events 2
|
18.8%
3/16 • Number of events 3
|
15.2%
7/46 • Number of events 7
|
23.1%
3/13 • Number of events 3
|
0.00%
0/5
|
8.7%
2/23 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
22.7%
10/44 • Number of events 10
|
18.8%
3/16 • Number of events 3
|
4.3%
2/46 • Number of events 24
|
23.1%
3/13 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
17.4%
4/23 • Number of events 4
|
|
Vascular disorders
Hypertension
|
18.2%
8/44 • Number of events 8
|
0.00%
0/16
|
8.7%
4/46 • Number of events 4
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
8.7%
2/23 • Number of events 2
|
|
Investigations
INR increased
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
White blood cell decreased
|
4.5%
2/44 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
13.0%
6/46 • Number of events 6
|
15.4%
2/13 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
17.4%
4/23 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
15.9%
7/44 • Number of events 7
|
12.5%
2/16 • Number of events 2
|
15.2%
7/46 • Number of events 7
|
30.8%
4/13 • Number of events 4
|
20.0%
1/5 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
3/44 • Number of events 3
|
0.00%
0/16
|
8.7%
4/46 • Number of events 4
|
15.4%
2/13 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
12/44 • Number of events 12
|
6.2%
1/16 • Number of events 1
|
15.2%
7/46 • Number of events 7
|
15.4%
2/13 • Number of events 2
|
0.00%
0/5
|
39.1%
9/23 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
2/44 • Number of events 2
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
3/44 • Number of events 3
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.7%
10/44 • Number of events 10
|
0.00%
0/16
|
26.1%
12/46 • Number of events 12
|
15.4%
2/13 • Number of events 2
|
60.0%
3/5 • Number of events 3
|
13.0%
3/23 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
34.1%
15/44 • Number of events 15
|
31.2%
5/16 • Number of events 5
|
37.0%
17/46 • Number of events 17
|
15.4%
2/13 • Number of events 2
|
60.0%
3/5 • Number of events 3
|
26.1%
6/23 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Number of events 3
|
0.00%
0/16
|
4.3%
2/46 • Number of events 2
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/44
|
18.8%
3/16 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Weight loss
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
0.00%
0/44
|
6.2%
1/16 • Number of events 1
|
0.00%
0/46
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/44
|
0.00%
0/16
|
6.5%
3/46 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Fever
|
0.00%
0/44
|
0.00%
0/16
|
6.5%
3/46 • Number of events 3
|
0.00%
0/13
|
0.00%
0/5
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
15.4%
2/13 • Number of events 2
|
0.00%
0/5
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
7.7%
1/13 • Number of events 1
|
0.00%
0/5
|
0.00%
0/23
|
|
Investigations
Platelet count decreased
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decrease
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/44
|
0.00%
0/16
|
0.00%
0/46
|
0.00%
0/13
|
20.0%
1/5 • Number of events 1
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60