Trial Outcomes & Findings for A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer (NCT NCT00090545)
NCT ID: NCT00090545
Last Updated: 2018-06-14
Results Overview
Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
4 months
Results posted on
2018-06-14
Participant Flow
Participant milestones
| Measure |
First Stage - Disease Progression
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
24
|
Reasons for withdrawal
| Measure |
First Stage - Disease Progression
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Overall Study
Disease progression on study
|
21
|
17
|
|
Overall Study
Refused further treatment
|
1
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
Baseline characteristics by cohort
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 7.04 • n=93 Participants
|
68.08 years
STANDARD_DEVIATION 10.17 • n=4 Participants
|
66.52 years
STANDARD_DEVIATION 8.87 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 monthsDetermine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Progression Free Survival
|
1.83 months
Interval 1.77 to 3.65
|
3.7 months
Interval 1.8 to 4.9
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 49 months.Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Time from treatment start date until date of death or date last known alive, approximately 18.3 months.Time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Median Overall Survival
|
18 Months
Interval 1.0 to 42.0
|
18.3 Months
Interval 1.0 to 42.0
|
SECONDARY outcome
Timeframe: Every 2 cycles (1 cycle = 28 days)Population: For stage 1, not all patients were analyzed for RECIST. Some patients came off study for rising prostatic specific antigen (PSA) only.
Overall response was evaluated by the RECIST. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
First Stage - Disease Progression
n=8 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 Participants
|
0 Participants
|
|
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
0 Participants
|
1 Participants
|
|
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
8 Participants
|
13 Participants
|
|
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dosePlasma concentration-time profile for sorafenib.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)
|
1.28 mg/L
Interval 0.88 to 1.87
|
2.57 mg/L
Interval 1.9 to 3.5
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-doseGeometric mean exposure for sorafenib.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Geometric Mean for Exposure Area Under the Curve (AUC) 0-12
|
9.76 mg/L.h
Interval 6.76 to 14.09
|
18.63 mg/L.h
Interval 13.1 to 26.4
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-doseTime to maximum concentration for sorafenib.
Outcome measures
| Measure |
First Stage - Disease Progression
n=22 Participants
The first stage was to rule out the probability of 4 month progression free survival.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 Participants
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)
|
0.68 hours
Interval 0.68 to 6.43
|
8 hours
Interval 2.0 to 12.2
|
Adverse Events
First Stage - Disease Progression
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Second Stage - Increased Accrual
Serious events: 6 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
First Stage - Disease Progression
n=22 participants at risk
The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 participants at risk
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Hemoglobin
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Pain::Head/headache
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
Other adverse events
| Measure |
First Stage - Disease Progression
n=22 participants at risk
The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
Second Stage - Increased Accrual
n=24 participants at risk
Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.
400 mg BAY 43-9006 orally twice daily in 28 day cycles.
|
|---|---|---|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
4.5%
1/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Weight loss
|
27.3%
6/22 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months.
|
37.5%
9/24 • Number of events 10 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Lipase
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Lymphopenia
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
13.6%
3/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Memory impairment
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Psychiatric disorders
Mood alteration::Anxiety
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Psychiatric disorders
Mood alteration::Depression
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Stomach
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
6/22 • Number of events 9 • Date treatment consent signed to date off study, approximately 49 months.
|
20.8%
5/24 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Neuropathy: sensory
|
13.6%
3/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
9.1%
2/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
13.6%
3/22 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
13.6%
3/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Pain::Face
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Pain::Head/headache
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
29.2%
7/24 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Renal and urinary disorders
Pain::Kidney
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
13.6%
3/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Pain::Neuralgia/peripheral nerve
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Pain::Oral-gums
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Reproductive system and breast disorders
Pain::Scrotum
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Cardiac disorders
Peripheral arterial ischemia
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
27.3%
6/22 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months.
|
41.7%
10/24 • Number of events 11 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Platelets
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
22.7%
5/22 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, phlegm (upper respiratory); upper respiratory))
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
31.8%
7/22 • Number of events 12 • Date treatment consent signed to date off study, approximately 49 months.
|
83.3%
20/24 • Number of events 24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
9.1%
2/22 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
58.3%
14/24 • Number of events 26 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Rigors/chills
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.6%
3/22 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
41.7%
10/24 • Number of events 11 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
22.7%
5/22 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
45.8%
11/24 • Number of events 13 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
22.7%
5/22 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months.
|
41.7%
10/24 • Number of events 10 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Alkaline phosphatase
|
22.7%
5/22 • Number of events 6 • Date treatment consent signed to date off study, approximately 49 months.
|
29.2%
7/24 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Amylase
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
4/22 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
50.0%
12/24 • Number of events 13 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Atrophy, skin
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify,congestion L. ear)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
9.1%
2/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
13.6%
3/22 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block::AV Block-First degree
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, keratoid canthomas; skin dryness)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
6/22 • Number of events 13 • Date treatment consent signed to date off study, approximately 49 months.
|
54.2%
13/24 • Number of events 16 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
4/22 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
27.3%
6/22 • Number of events 7 • Date treatment consent signed to date off study, approximately 49 months.
|
75.0%
18/24 • Number of events 22 • Date treatment consent signed to date off study, approximately 49 months.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, soft stool x1 a day)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
9.1%
2/22 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
9.1%
2/22 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
20.8%
5/24 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Investigations
Hemoglobin
|
9.1%
2/22 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
29.2%
7/24 • Number of events 8 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
12.5%
3/24 • Number of events 4 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Hypertension
|
13.6%
3/22 • Number of events 5 • Date treatment consent signed to date off study, approximately 49 months.
|
29.2%
7/24 • Number of events 8 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Renal and urinary disorders
Incontinence, urinary
|
4.5%
1/22 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 49 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • Date treatment consent signed to date off study, approximately 49 months.
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 49 months.
|
Additional Information
William Dahut, M.D.
National Cancer Institute, National Institues of Health
Phone: 301-435-8183
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place