Trial Outcomes & Findings for Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer (NCT NCT00126503)
NCT ID: NCT00126503
Last Updated: 2015-01-15
Results Overview
The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with fever \> 101 degrees Fahrenheit, platelet count \< 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) \>= Grade 3.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
at 28 days
Results posted on
2015-01-15
Participant Flow
This Phase I/II study was open 5/2005 through 12/2010.
73 patients consented, 4 of whom were determined to be ineligible.
Participant milestones
| Measure |
Phase I
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
21
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
21
|
Reasons for withdrawal
| Measure |
Phase I
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Overall Study
disease progression
|
23
|
14
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
alternative therapy
|
1
|
1
|
|
Overall Study
other complicating disease
|
4
|
1
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Adverse Event
|
13
|
3
|
|
Overall Study
non-compliant
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
Phase I
n=48 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=21 Participants
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 1 • n=99 Participants
|
58 years
STANDARD_DEVIATION 1 • n=107 Participants
|
62 years
STANDARD_DEVIATION 1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
21 participants
n=107 Participants
|
69 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 28 daysPopulation: Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab
The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with fever \> 101 degrees Fahrenheit, platelet count \< 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) \>= Grade 3.
Outcome measures
| Measure |
Phase I
n=48 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)
|
200 mg
|
—
|
PRIMARY outcome
Timeframe: at 28 daysPopulation: Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab
The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with fever \> 101 degrees Fahrenheit, platelet count \< 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) \>= Grade 3.
Outcome measures
| Measure |
Phase I
n=48 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)
|
5 mg/kg
|
—
|
PRIMARY outcome
Timeframe: Every 8 weeks to date of progressionPopulation: Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.
Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive
Outcome measures
| Measure |
Phase I
n=41 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=17 Participants
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Objective Response
Complete Response
|
0 participants
Interval 5.0 to 48.0
|
0 participants
|
|
Objective Response
Partial Response
|
23 participants
|
3 participants
|
|
Objective Response
Progressive Disease
|
2 participants
|
0 participants
|
|
Objective Response
Stable Disease
|
16 participants
|
14 participants
|
SECONDARY outcome
Timeframe: on-study to date of expired or last date known alivePopulation: All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.
Months from date on-study to expired or last date known alive
Outcome measures
| Measure |
Phase I
n=48 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=21 Participants
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Overall Survival
|
24 months
Interval 1.0 to 73.0
|
25 months
Interval 5.0 to 59.0
|
SECONDARY outcome
Timeframe: on-study to date of progression or last date known alive without progressionPopulation: All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.
Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.
Outcome measures
| Measure |
Phase I
n=48 Participants
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=21 Participants
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Progression-free Survival
|
11 months
Interval 1.0 to 56.0
|
15 months
Interval 1.0 to 49.0
|
Adverse Events
Phase I
Serious events: 17 serious events
Other events: 48 other events
Deaths: 0 deaths
Phase II
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I
n=48 participants at risk
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=21 participants at risk
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
General disorders
Edema-limb
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory-nose
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain-chest wall
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-Other
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Nervous system disorders
Neuropathy - sensory
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Pain-abdomen NOS
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-joint
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Proteinuria
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Somnomolence/depressed level of consciousness
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Hyperuricemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Vascular-other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection with unknown ANC-pancreas
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection with unknown ANC-lung (pneumonia)
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Death not associated with CTCAE term-Disease progression NOS
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia-atrial fibrillation
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection-Other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection with Grade 1 or 2 neutrophils (ANC < 1.0 x 10e9/L)-skin (cellulitis)
|
4.2%
2/48 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Hypertension
|
20.8%
10/48 • Number of events 10
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Wound complication, non-infectious
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI-gallbladder
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Cardiac General-other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-bone (osteomyelitis)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-back
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Perforation, GI-colon
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia-atrial flutter
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Fatigue
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
stricture/stenosis (including anastomotic), GI-jejunum
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Oral mucositis
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
palmar-plantar paresthesia
|
20.8%
10/48 • Number of events 10
|
0.00%
0/21
|
|
Investigations
weight loss
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
Phase I
n=48 participants at risk
Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
|
Phase II
n=21 participants at risk
Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
|
|---|---|---|
|
Immune system disorders
allergic reaction/hypersensivity
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Immune system disorders
allergic rhinitis
|
37.5%
18/48 • Number of events 33
|
47.6%
10/21 • Number of events 10
|
|
Investigations
ALT/SGPT (serum glutamine pyruvic transminase)
|
22.9%
11/48 • Number of events 28
|
19.0%
4/21 • Number of events 9
|
|
Gastrointestinal disorders
Anorexia
|
58.3%
28/48 • Number of events 72
|
47.6%
10/21 • Number of events 11
|
|
Investigations
AST, SGOT (serum glutamine oxaloacetic transminase)
|
22.9%
11/48 • Number of events 30
|
19.0%
4/21 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm-wheezing
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3/4 thromboctyopenia)
|
8.3%
4/48 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
45.8%
22/48 • Number of events 38
|
38.1%
8/21 • Number of events 12
|
|
General disorders
Constitutional symptoms Other
|
6.2%
3/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.6%
19/48 • Number of events 30
|
47.6%
10/21 • Number of events 13
|
|
Metabolism and nutrition disorders
Creatinine
|
18.8%
9/48 • Number of events 24
|
9.5%
2/21 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
3/48 • Number of events 4
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dental-teeth
|
0.00%
0/48
|
9.5%
2/21 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
29.2%
14/48 • Number of events 31
|
28.6%
6/21 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhea
|
68.8%
33/48 • Number of events 171
|
42.9%
9/21 • Number of events 29
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
8.3%
4/48 • Number of events 10
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
22.9%
11/48 • Number of events 19
|
23.8%
5/21 • Number of events 5
|
|
Eye disorders
Dry eye syndrome
|
8.3%
4/48 • Number of events 8
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
10.4%
5/48 • Number of events 8
|
19.0%
4/21 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
16/48 • Number of events 26
|
33.3%
7/21 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
14.6%
7/48 • Number of events 12
|
14.3%
3/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
10/48 • Number of events 16
|
19.0%
4/21 • Number of events 6
|
|
General disorders
Edema head and neck
|
6.2%
3/48 • Number of events 4
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Edema limb
|
14.6%
7/48 • Number of events 13
|
28.6%
6/21 • Number of events 6
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Extemity-lower (gait/walking)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fatigue
|
79.2%
38/48 • Number of events 140
|
61.9%
13/21 • Number of events 37
|
|
General disorders
Fever (in the absence of neutropenia, with neutropenia defined as ANC < 1.0 x 10e9/L
|
6.2%
3/48 • Number of events 3
|
9.5%
2/21 • Number of events 3
|
|
Gastrointestinal disorders
fistula-GI anus
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
37.5%
18/48 • Number of events 32
|
19.0%
4/21 • Number of events 5
|
|
General disorders
Flu-like syndrome
|
6.2%
3/48 • Number of events 6
|
9.5%
2/21 • Number of events 2
|
|
Vascular disorders
Flushing
|
8.3%
4/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
16.7%
8/48 • Number of events 14
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hair loss-scalp or body
|
10.4%
5/48 • Number of events 15
|
28.6%
6/21 • Number of events 6
|
|
Gastrointestinal disorders
Heartburn, dyspepsia
|
43.8%
21/48 • Number of events 41
|
28.6%
6/21 • Number of events 9
|
|
Infections and infestations
Hemoglobin
|
18.8%
9/48 • Number of events 30
|
14.3%
3/21 • Number of events 9
|
|
Gastrointestinal disorders
Hemorrhage, GI-lower GI NOS
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI oral cavity
|
8.3%
4/48 • Number of events 6
|
19.0%
4/21 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhage, GI rectum
|
8.3%
4/48 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage, GU urinary
|
0.00%
0/48
|
19.0%
4/21 • Number of events 4
|
|
Reproductive system and breast disorders
Hemorrhage, GU vaginal
|
0.00%
0/48
|
4.8%
1/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory-nose
|
31.2%
15/48 • Number of events 26
|
42.9%
9/21 • Number of events 13
|
|
Gastrointestinal disorders
Hemorrhoids
|
18.8%
9/48 • Number of events 11
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Hypercalcemia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.9%
11/48 • Number of events 26
|
19.0%
4/21 • Number of events 40
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.4%
5/48 • Number of events 9
|
4.8%
1/21 • Number of events 2
|
|
Vascular disorders
Hypertension
|
41.7%
20/48 • Number of events 54
|
71.4%
15/21 • Number of events 26
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.4%
5/48 • Number of events 8
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
3/48 • Number of events 8
|
9.5%
2/21 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.4%
5/48 • Number of events 8
|
19.0%
4/21 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.9%
11/48 • Number of events 22
|
14.3%
3/21 • Number of events 24
|
|
Infections and infestations
Infection-Other
|
0.00%
0/48
|
9.5%
2/21 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-cellulitis
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
22.9%
11/48 • Number of events 13
|
28.6%
6/21 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 4
|
|
Nervous system disorders
Memory impairment
|
10.4%
5/48 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/laboratory-Other
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Psychiatric disorders
Mood alteration-agitation
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Psychiatric disorders
Mood alteration-anxiety
|
20.8%
10/48 • Number of events 12
|
9.5%
2/21 • Number of events 2
|
|
Psychiatric disorders
Mood alteration-depression
|
20.8%
10/48 • Number of events 11
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis-anus/rectum (functional/symptomatic)
|
6.2%
3/48 • Number of events 13
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis-oral cavity (clinical exam)
|
47.9%
23/48 • Number of events 43
|
42.9%
9/21 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area-upper extremity/whole body/generalized
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-Other
|
10.4%
5/48 • Number of events 7
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.4%
5/48 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
52.1%
25/48 • Number of events 57
|
42.9%
9/21 • Number of events 23
|
|
Nervous system disorders
Neurology-Other
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Nervous system disorders
Neuropathy - sensory
|
31.2%
15/48 • Number of events 42
|
23.8%
5/21 • Number of events 7
|
|
Metabolism and nutrition disorders
Obesity
|
8.3%
4/48 • Number of events 8
|
14.3%
3/21 • Number of events 4
|
|
Eye disorders
Ocular/visual-Other
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pain-abdomen NOS
|
35.4%
17/48 • Number of events 35
|
28.6%
6/21 • Number of events 11
|
|
General disorders
Pain-anus/rectum
|
8.3%
4/48 • Number of events 5
|
0.00%
0/21
|
|
General disorders
Pain-back
|
35.4%
17/48 • Number of events 30
|
38.1%
8/21 • Number of events 17
|
|
General disorders
Pain-bone
|
8.3%
4/48 • Number of events 7
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Pain-chest/thorax
|
12.5%
6/48 • Number of events 6
|
19.0%
4/21 • Number of events 7
|
|
General disorders
Pain-dental/periodontal
|
8.3%
4/48 • Number of events 9
|
0.00%
0/21
|
|
Nervous system disorders
Pain-Head/headache
|
54.2%
26/48 • Number of events 53
|
61.9%
13/21 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain-joint
|
35.4%
17/48 • Number of events 35
|
28.6%
6/21 • Number of events 16
|
|
General disorders
Pain-oral cavity/gums
|
16.7%
8/48 • Number of events 12
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pain-Other/NOS
|
20.8%
10/48 • Number of events 14
|
19.0%
4/21 • Number of events 8
|
|
General disorders
Pain-pelvis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Pain-sinus
|
8.3%
4/48 • Number of events 9
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Pain-stomach
|
12.5%
6/48 • Number of events 10
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pain-throat, pharynx
|
20.8%
10/48 • Number of events 17
|
23.8%
5/21 • Number of events 11
|
|
Investigations
Platelets
|
8.3%
4/48 • Number of events 18
|
4.8%
1/21 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
22.9%
11/48 • Number of events 49
|
42.9%
9/21 • Number of events 56
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.8%
10/48 • Number of events 15
|
23.8%
5/21 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary\upper respiratory-Other
|
16.7%
8/48 • Number of events 13
|
19.0%
4/21 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
37.5%
18/48 • Number of events 30
|
42.9%
9/21 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Rash acne/actiform
|
27.1%
13/48 • Number of events 17
|
14.3%
3/21 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
palmar/plantar paresthesia
|
56.2%
27/48 • Number of events 195
|
81.0%
17/21 • Number of events 41
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Rigor, chills
|
18.8%
9/48 • Number of events 13
|
28.6%
6/21 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Sweating/diphoresis
|
10.4%
5/48 • Number of events 10
|
14.3%
3/21 • Number of events 4
|
|
Nervous system disorders
Syncope/fainting
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
29.2%
14/48 • Number of events 26
|
23.8%
5/21 • Number of events 6
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/48
|
14.3%
3/21 • Number of events 3
|
|
Renal and urinary disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/48
|
14.3%
3/21 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.4%
5/48 • Number of events 7
|
9.5%
2/21 • Number of events 4
|
|
Vascular disorders
Vascular-other
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
16.7%
8/48 • Number of events 9
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.00%
0/48
|
14.3%
3/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
68.8%
33/48 • Number of events 58
|
66.7%
14/21 • Number of events 21
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
16/48 • Number of events 28
|
23.8%
5/21 • Number of events 9
|
|
Investigations
Weight loss
|
54.2%
26/48 • Number of events 67
|
42.9%
9/21 • Number of events 19
|
|
Investigations
Alkaline phosphatase
|
8.3%
4/48 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/48
|
19.0%
4/21 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Bicarbonate, serum-low
|
0.00%
0/48
|
9.5%
2/21 • Number of events 6
|
|
Investigations
Hyperbilirubinemia
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 2
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Chelitis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Endocrine disorders
Endocrine other
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessnes
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/48
|
9.5%
2/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-cellulitis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-soft tissue
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Reproductive system and breast disorders
Pain-breast
|
6.2%
3/48 • Number of events 4
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain-extremity. limb
|
33.3%
16/48 • Number of events 31
|
38.1%
8/21 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain-buttock
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-muscle
|
20.8%
10/48 • Number of events 11
|
14.3%
3/21 • Number of events 3
|
|
General disorders
Pain-neck
|
12.5%
6/48 • Number of events 6
|
14.3%
3/21 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pain-skin
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Hypophosphatemia
|
22.9%
11/48 • Number of events 54
|
23.8%
5/21 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pain-scalp
|
20.8%
10/48 • Number of events 12
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Tumor pain
|
6.2%
3/48 • Number of events 8
|
0.00%
0/21
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
6.2%
3/48 • Number of events 4
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Weight gain
|
8.3%
4/48 • Number of events 5
|
0.00%
0/21
|
|
Psychiatric disorders
Confusion
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Vascular disorders
Hypotension
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Ear and labyrinth disorders
Infection with normal ANC or Grade 1 or 2 neutrophils-external ear
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Infection with normal ANC or Grade 1 or 2 neutrophils-Eye NOS
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection with normal ANC or Grade 1 or 2 neutrophils-lung (pneumonia)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Infection with unknown ANC-stomach
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-wound
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Leak (including anastomatic)-GI-rectum
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Occular surface disease
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Partial prothrombin time (PTT)
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia-atrial tachycardia/paroxysmal atrial tachycardia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Triglyceride, serum-high
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-sinus
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Infection with normal ANC or Grade 1 or 2 neutrophils-upper airway NOS
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Pain-chest wall
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/48
|
14.3%
3/21 • Number of events 4
|
|
Infections and infestations
Mucositis/stomatitis (functional/symptomatic)-Oral cavity
|
0.00%
0/48
|
33.3%
7/21 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis/pumonary infiltrates
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Vessel injury-vein-extremity-limb
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60