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A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00090545
Recruitment Status : Completed
First Posted : August 27, 2004
Results First Posted : September 28, 2012
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
William Dahut Jr., M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: BAY 43-9006
Enrollment 46

Recruitment Details  
Pre-assignment Details  
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 22 24
Completed 0 0
Not Completed 22 24
Reason Not Completed
Disease progression on study             21             17
Refused further treatment             1             4
Death             0             1
Adverse Event             0             2
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 22 24 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  59.1%
10
  41.7%
23
  50.0%
>=65 years
9
  40.9%
14
  58.3%
23
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 24 participants 46 participants
64.8  (7.04) 68.08  (10.17) 66.52  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
22
 100.0%
24
 100.0%
46
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Hispanic or Latino
1
   4.5%
1
   4.2%
2
   4.3%
Not Hispanic or Latino
21
  95.5%
23
  95.8%
44
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.5%
5
  20.8%
6
  13.0%
White
21
  95.5%
19
  79.2%
40
  87.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 24 participants 46 participants
22
 100.0%
24
 100.0%
46
 100.0%
1.Primary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 24
Median (95% Confidence Interval)
Unit of Measure: months
1.83
(1.77 to 3.65)
3.7
(1.8 to 4.9)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Time Frame Date treatment consent signed to date off study, approximately 49 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 24
Measure Type: Count of Participants
Unit of Measure: Participants
22
 100.0%
23
  95.8%
3.Secondary Outcome
Title Median Overall Survival
Hide Description Time from treatment start date until date of death or date last known alive.
Time Frame Time from treatment start date until date of death or date last known alive, approximately 18.3 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 24
Median (95% Confidence Interval)
Unit of Measure: Months
18
(1 to 42)
18.3
(1 to 42)
4.Secondary Outcome
Title Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description 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.
Time Frame Every 2 cycles (1 cycle = 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For stage 1, not all patients were analyzed for RECIST. Some patients came off study for rising prostatic specific antigen (PSA) only.
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 24
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
1
   4.2%
Progressive Disease
8
 100.0%
13
  54.2%
Stable Disease
0
   0.0%
10
  41.7%
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)
Hide Description Plasma concentration-time profile for sorafenib.
Time Frame 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 24
Mean (Full Range)
Unit of Measure: mg/L
1.28
(0.88 to 1.87)
2.57
(1.9 to 3.5)
6.Secondary Outcome
Title Geometric Mean for Exposure Area Under the Curve (AUC) 0-12
Hide Description Geometric mean exposure for sorafenib.
Time Frame 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L.h
9.76
(6.76 to 14.09)
18.63
(13.1 to 26.4)
7.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)
Hide Description Time to maximum concentration for sorafenib.
Time Frame 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 24
Median (Full Range)
Unit of Measure: hours
0.68
(0.68 to 6.43)
8
(2 to 12.2)
Time Frame Date treatment consent signed to date off study, approximately 49 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First Stage - Disease Progression Second Stage - Increased Accrual
Hide Arm/Group Description

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.

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.

All-Cause Mortality
First Stage - Disease Progression Second Stage - Increased Accrual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      1/24 (4.17%)    
Show Serious Adverse Events Hide Serious Adverse Events
First Stage - Disease Progression Second Stage - Increased Accrual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      6/24 (25.00%)    
Gastrointestinal disorders     
Constipation  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Dehydration  1  0/22 (0.00%)  0 1/24 (4.17%)  1
General disorders     
Death not associated with CTCAE term::Death NOS  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Infections and infestations     
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Investigations     
Hemoglobin  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders     
Pain::Back  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Bone  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Joint  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Muscle  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders     
CNS cerebrovascular ischemia  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Head/headache  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Vascular disorders     
Hypertension  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Hypotension  1  1/22 (4.55%)  1 0/24 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
First Stage - Disease Progression Second Stage - Increased Accrual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      23/24 (95.83%)    
Cardiac disorders     
Conduction abnormality/atrioventricular heart block::AV Block-First degree  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pericarditis  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Peripheral arterial ischemia  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Supraventricular and nodal arrhythmia::Sinus bradycardia  1  1/22 (4.55%)  2 0/24 (0.00%)  0
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Ear and labyrinth disorders     
Auditory/Ear - Other (Specify,congestion L. ear)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Endocrine disorders     
Thyroid function, low (hypothyroidism)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Eye disorders     
Vision-blurred vision  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Gastrointestinal disorders     
Constipation  1  0/22 (0.00%)  0 2/24 (8.33%)  3
Diarrhea  1  6/22 (27.27%)  13 13/24 (54.17%)  16
Distension/bloating, abdominal  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Dry mouth/salivary gland (xerostomia)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Dysphagia (difficulty swallowing)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Flatulence  1  2/22 (9.09%)  2 2/24 (8.33%)  3
Gastrointestinal - Other (Specify, soft stool x1 a day)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Heartburn/dyspepsia  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Hemorrhage, GI::Oral cavity  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Hemorrhage, GI::Rectum  1  1/22 (4.55%)  1 2/24 (8.33%)  2
Mucositis/stomatitis (functional/symptomatic)::Oral cavity  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Mucositis/stomatitis (functional/symptomatic)::Stomach  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Nausea  1  6/22 (27.27%)  9 5/24 (20.83%)  6
Pain::Abdomen NOS  1  2/22 (9.09%)  2 0/24 (0.00%)  0
Pain::Oral cavity  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Oral-gums  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Taste alteration (dysgeusia)  1  1/22 (4.55%)  1 2/24 (8.33%)  2
Vomiting  1  3/22 (13.64%)  4 1/24 (4.17%)  1
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  6/22 (27.27%)  7 18/24 (75.00%)  22
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Pain::Face  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Pain NOS  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Rigors/chills  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Infections and infestations     
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Injury, poisoning and procedural complications     
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Investigations     
Alkaline phosphatase  1  5/22 (22.73%)  6 7/24 (29.17%)  7
Amylase  1  2/22 (9.09%)  2 1/24 (4.17%)  1
Bilirubin (hyperbilirubinemia)  1  2/22 (9.09%)  3 3/24 (12.50%)  4
Cholesterol, serum-high (hypercholesteremia)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Hemoglobin  1  2/22 (9.09%)  4 7/24 (29.17%)  8
Leukocytes (total WBC)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Lipase  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Lymphopenia  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Neutrophils/granulocytes (ANC/AGC)  1  0/22 (0.00%)  0 2/24 (8.33%)  2
PTT (Partial Thromboplastin Time)  1  2/22 (9.09%)  3 1/24 (4.17%)  1
Platelets  1  0/22 (0.00%)  0 3/24 (12.50%)  3
Weight loss  1  6/22 (27.27%)  6 9/24 (37.50%)  10
Metabolism and nutrition disorders     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/22 (4.55%)  1 10/24 (41.67%)  11
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  5/22 (22.73%)  5 11/24 (45.83%)  13
Albumin, serum-low (hypoalbuminemia)  1  5/22 (22.73%)  6 10/24 (41.67%)  10
Anorexia  1  4/22 (18.18%)  4 12/24 (50.00%)  13
Calcium, serum-high (hypercalcemia)  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Calcium, serum-low (hypocalcemia)  1  3/22 (13.64%)  3 0/24 (0.00%)  0
Glucose, serum-high (hyperglycemia)  1  2/22 (9.09%)  4 3/24 (12.50%)  3
Glucose, serum-low (hypoglycemia)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Magnesium, serum-high (hypermagnesemia)  1  3/22 (13.64%)  3 3/24 (12.50%)  3
Magnesium, serum-low (hypomagnesemia)  1  2/22 (9.09%)  2 2/24 (8.33%)  2
Phosphate, serum-low (hypophosphatemia)  1  6/22 (27.27%)  7 10/24 (41.67%)  11
Potassium, serum-high (hyperkalemia)  1  1/22 (4.55%)  1 2/24 (8.33%)  2
Potassium, serum-low (hypokalemia)  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Sodium, serum-low (hyponatremia)  1  3/22 (13.64%)  7 3/24 (12.50%)  4
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Osteonecrosis (avascular necrosis)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Back  1  3/22 (13.64%)  5 2/24 (8.33%)  3
Pain::Bone  1  0/22 (0.00%)  0 3/24 (12.50%)  3
Pain::Chest wall  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Pain::Extremity-limb  1  3/22 (13.64%)  3 2/24 (8.33%)  4
Pain::Joint  1  2/22 (9.09%)  2 7/24 (29.17%)  7
Pain::Muscle  1  3/22 (13.64%)  3 3/24 (12.50%)  4
Nervous system disorders     
Ataxia (incoordination)  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Extrapyramidal/involuntary movement/restlessness  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Memory impairment  1  1/22 (4.55%)  1 1/24 (4.17%)  1
Neuropathy: sensory  1  3/22 (13.64%)  3 2/24 (8.33%)  2
Pain::Head/headache  1  0/22 (0.00%)  0 2/24 (8.33%)  3
Pain::Neuralgia/peripheral nerve  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Psychiatric disorders     
Insomnia  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Mood alteration::Anxiety  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Mood alteration::Depression  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Renal and urinary disorders     
Incontinence, urinary  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Pain::Kidney  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Urinary frequency/urgency  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Urinary retention (including neurogenic bladder)  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Reproductive system and breast disorders     
Pain::Pelvis  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Pain::Scrotum  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/22 (9.09%)  2 2/24 (8.33%)  2
Dyspnea (shortness of breath)  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Hemorrhage, pulmonary/upper respiratory::Nose  1  0/22 (0.00%)  0 3/24 (12.50%)  4
Nasal cavity/paranasal sinus reactions  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Pain::Throat/pharynx/larynx  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Pulmonary/Upper Respiratory - Other (Specify, phlegm (upper respiratory); upper respiratory))  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  1/22 (4.55%)  1 3/24 (12.50%)  3
Skin and subcutaneous tissue disorders     
Atrophy, skin  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Dermatology/Skin - Other (Specify, keratoid canthomas; skin dryness)  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Dry skin  1  4/22 (18.18%)  4 1/24 (4.17%)  1
Hair loss/alopecia (scalp or body)  1  2/22 (9.09%)  2 5/24 (20.83%)  5
Nail changes  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Pruritus/itching  1  5/22 (22.73%)  5 3/24 (12.50%)  3
Rash/desquamation  1  7/22 (31.82%)  12 20/24 (83.33%)  24
Rash: acne/acneiform  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Rash: hand-foot skin reaction  1  2/22 (9.09%)  5 14/24 (58.33%)  26
Sweating (diaphoresis)  1  0/22 (0.00%)  0 2/24 (8.33%)  2
Vascular disorders     
Flushing  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Hot flashes/flushes  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Hypertension  1  3/22 (13.64%)  5 7/24 (29.17%)  8
Hypotension  1  0/22 (0.00%)  0 1/24 (4.17%)  1
Thrombosis/embolism (vascular access-related)  1  0/22 (0.00%)  0 2/24 (8.33%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: William Dahut, M.D.
Organization: National Cancer Institute, National Institues of Health
Phone: 301-435-8183
Other Publications:
Responsible Party: William Dahut Jr., M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00090545     History of Changes
Obsolete Identifiers: NCT00093431
Other Study ID Numbers: 040262
04-C-0262
First Submitted: August 27, 2004
First Posted: August 27, 2004
Results First Submitted: July 23, 2012
Results First Posted: September 28, 2012
Last Update Posted: June 14, 2018