Trial Outcomes & Findings for Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer (NCT NCT00390325)
NCT ID: NCT00390325
Last Updated: 2024-02-06
Results Overview
Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 4 weeks after last dose of sorafenib tosylate
Results posted on
2024-02-06
Participant Flow
November 2006 and January 2008
Participant milestones
| Measure |
Arm A (Hereditary MTC)
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
16
|
|
Overall Study
COMPLETED
|
5
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Hereditary MTC)
n=5 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
n=16 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 patients
n=5 Participants
|
13 patients
n=7 Participants
|
18 patients
n=5 Participants
|
|
Race/Ethnicity, Customized
Nonwhite
|
0 patients
n=5 Participants
|
3 patients
n=7 Participants
|
3 patients
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: 1 patient was not evaluable for RECIST evaluation in Arm B
Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=5 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
n=15 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: 1 patient was not evaluable in Arm B
Identifying the number of patients with decreased calcitonin levels
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=5 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
n=15 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Number of Patients With Decreased Calcitonin Levels
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: 1 patient was not evaluable in Arm B
Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=5 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
n=15 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Patient With Decreased Carcinoembryonic Antigen (CEA) Levels
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: kep \[exchange rate constant\]
Median decrease in exchange rate Kep in index lesions
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=10 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep)
|
79 percentage change
Interval 25.0 to 96.0
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: Due to low tumor cellularity in the samples obtained, such evaluation was not possible
Identify the number of patients with degree of Ras-MAPK signaling inhibition
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylatePopulation: No data available
Correlated with clinical response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylateIdentify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=9 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET)
Baseline
|
3.73 maximum SUV
Interval 2.84 to 4.63
|
—
|
|
Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET)
8 week follow up
|
2.94 maximum SUV
Interval 2.24 to 3.88
|
—
|
SECONDARY outcome
Timeframe: Up to 4 weeks after last dose of sorafenib tosylateToxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=21 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Diarrhea
|
10 Participants
|
—
|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Oral cavity pain
|
13 Participants
|
—
|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Alopecia
|
16 Participants
|
—
|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Hypertension
|
10 Participants
|
—
|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
HFSR
|
14 Participants
|
—
|
|
Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Pulmonary Embolism
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePercent of patients with RET mutations
Outcome measures
| Measure |
Arm A (Hereditary MTC)
n=5 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
Arm B (Sporadic MTC)
n=12 Participants
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|---|
|
Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Due to low tumor cellularity in the samples obtained, such evaluation was not possible
Changes will be correlated with toxicity and clinical response to therapy.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Serious events: 5 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
n=21 participants at risk
Arm A:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Arm B:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Perforation, GI-small bowel
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Renal and urinary disorders
Renal Failure
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Vascular disorders
Thrombosis/Thrombus/embois
|
4.8%
1/21 • Number of events 1 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
Other adverse events
| Measure |
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
n=21 participants at risk
Arm A:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Arm B:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
|
|---|---|
|
General disorders
Weight loss
|
47.6%
10/21 • Number of events 10 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Anorexia
|
38.1%
8/21 • Number of events 8 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
General disorders
Fatigue
|
33.3%
7/21 • Number of events 7 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Taste Changes
|
19.0%
4/21 • Number of events 4 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Diarrhea
|
81.0%
17/21 • Number of events 17 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Oral Cavity Pain
|
61.9%
13/21 • Number of events 13 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Mucositis
|
47.6%
10/21 • Number of events 10 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Flatulence
|
38.1%
8/21 • Number of events 8 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
28.6%
6/21 • Number of events 6 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Abdominal bloating
|
19.0%
4/21 • Number of events 4 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
General disorders
Nausea
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Gastrointestinal disorders
Heartburn
|
9.5%
2/21 • Number of events 2 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
HFSR
|
90.5%
19/21 • Number of events 19 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
76.2%
16/21 • Number of events 16 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
14/21 • Number of events 14 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
47.6%
10/21 • Number of events 10 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Dry skin/scalp
|
47.6%
10/21 • Number of events 10 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Skin lesions/sores
|
38.1%
8/21 • Number of events 8 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Scalp pruritis
|
33.3%
7/21 • Number of events 7 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Vascular disorders
Hypertension
|
52.4%
11/21 • Number of events 11 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Vascular disorders
Flushing
|
42.9%
9/21 • Number of events 9 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle pain or cramping
|
52.4%
11/21 • Number of events 11 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
42.9%
9/21 • Number of events 9 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Scalp pain
|
33.3%
7/21 • Number of events 7 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Infections and infestations
Infection
|
28.6%
6/21 • Number of events 6 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
Leukopenia
|
52.4%
11/21 • Number of events 11 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
Neutropenia
|
33.3%
7/21 • Number of events 7 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
Lymphopenia
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Injury, poisoning and procedural complications
Thrombocytopenia
|
52.4%
11/21 • Number of events 11 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Blood and lymphatic system disorders
Anemia
|
38.1%
8/21 • Number of events 8 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
AST
|
42.9%
9/21 • Number of events 9 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
LDH
|
61.9%
13/21 • Number of events 13 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
ALT
|
38.1%
8/21 • Number of events 8 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
Bilirubin
|
19.0%
4/21 • Number of events 4 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Investigations
Alkaline phosphatase
|
14.3%
3/21 • Number of events 3 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
57.1%
12/21 • Number of events 12 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
57.1%
12/21 • Number of events 12 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
12/21 • Number of events 12 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.0%
4/21 • Number of events 4 • All patients will be evaluable for toxicity from the time of their first treatment with sorafenib (BAY 43-9006) until off study, up to 4 weeks after last dose of sorafenib tosylate", "through study completion, an average of 1 year.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
|
Additional Information
Manisha Shah, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8629
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60