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Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00390325
Recruitment Status : Active, not recruiting
First Posted : October 19, 2006
Results First Posted : December 21, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hereditary Thyroid Gland Medullary Carcinoma
Locally Advanced Thyroid Gland Medullary Carcinoma
Multiple Endocrine Neoplasia Type 2A
Multiple Endocrine Neoplasia Type 2B
Recurrent Thyroid Gland Medullary Carcinoma
Sporadic Thyroid Gland Medullary Carcinoma
Stage III Thyroid Gland Medullary Carcinoma AJCC v7
Stage IV Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7
Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7
Intervention Drug: Sorafenib Tosylate
Enrollment 21
Recruitment Details November 2006 and January 2008
Pre-assignment Details  
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis. Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Period Title: Overall Study
Started 5 16
Completed 5 16
Not Completed 0 0
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC) Total
Hide Arm/Group Description Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis. Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis. Total of all reporting groups
Overall Number of Baseline Participants 5 16 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 16 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  40.0%
6
  37.5%
8
  38.1%
>=65 years
3
  60.0%
10
  62.5%
13
  61.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 16 participants 21 participants
Female
0
   0.0%
11
  68.8%
11
  52.4%
Male
5
 100.0%
5
  31.3%
10
  47.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 5 participants 16 participants 21 participants
White 5 13 18
Nonwhite 0 3 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 16 participants 21 participants
5 16 21
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was not evaluable for RECIST evaluation in Arm B
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Overall Number of Participants Analyzed 5 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
  20.0%
1
   6.7%
2.Secondary Outcome
Title Number of Patients With Decreased Calcitonin Levels
Hide Description Identifying the number of patients with decreased calcitonin levels
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was not evaluable in Arm B
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 5 15
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
11
  73.3%
3.Secondary Outcome
Title Patient With Decreased Carcinoembryonic Antigen (CEA) Levels
Hide Description Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was not evaluable in Arm B
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 5 15
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
8
  53.3%
4.Secondary Outcome
Title Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep)
Hide Description Median decrease in exchange rate Kep in index lesions
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
kep [exchange rate constant]
Arm/Group Title Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: percentage change
79
(25 to 96)
5.Secondary Outcome
Title Degree of Ras-MAPK Signaling Inhibition in the Tumor
Hide Description Identify the number of patients with degree of Ras-MAPK signaling inhibition
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
Due to low tumor cellularity in the samples obtained, such evaluation was not possible
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor
Hide Description Correlated with clinical response.
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
No data available
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
MTC in setting of inherited syndromes (MEN-2A, 2B or FMTC) plus Measurable disease Plus No prior ZD6474 or AMG 706
MTC in setting of sporadic ds plus Measurable disease Plus No prior ZD6474 or AMG 706
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET)
Hide Description Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: maximum SUV
Baseline
3.73
(2.84 to 4.63)
8 week follow up
2.94
(2.24 to 3.88)
8.Secondary Outcome
Title Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame Up to 4 weeks after last dose of sorafenib tosylate
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Diarrhea
10
  47.6%
Oral cavity pain
13
  61.9%
Alopecia
16
  76.2%
Hypertension
10
  47.6%
HFSR
14
  66.7%
Pulmonary Embolism
5
  23.8%
9.Secondary Outcome
Title Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor
Hide Description Percent of patients with RET mutations
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Overall Number of Participants Analyzed 5 12
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
10
  83.3%
10.Secondary Outcome
Title Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity
Hide Description Changes will be correlated with toxicity and clinical response to therapy.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Due to low tumor cellularity in the samples obtained, such evaluation was not possible
Arm/Group Title Arm A (Hereditary MTC) Arm B (Sporadic MTC)
Hide Arm/Group Description:
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Sorafenib (BAY 43-9006) was administered at the dose of 400 mg orally twice a day on a continuous basis.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting
 
Arm/Group Title Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Hide Arm/Group Description

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.

All-Cause Mortality
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Affected / at Risk (%)
Total   1/21 (4.76%)    
Hide Serious Adverse Events
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Affected / at Risk (%) # Events
Total   5/21 (23.81%)    
Cardiac disorders   
Cardiac ischemia/infarction  1  1/21 (4.76%)  1
Gastrointestinal disorders   
Perforation, GI-small bowel  1  1/21 (4.76%)  1
Infections and infestations   
Infection  1 [1]  1/21 (4.76%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  1/21 (4.76%)  1
Renal and urinary disorders   
Renal Failure  1  1/21 (4.76%)  1
Vascular disorders   
Thrombosis/Thrombus/embois  1  1/21 (4.76%)  1
1
Term from vocabulary, CTCAE version 3.0
Indicates events were collected by systematic assessment
[1]
Infection with normal ANC or Grade 1 or 2 neutrophils-Colon
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Hereditary MTC) and Arm B (Sporadic MTC)
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  8/21 (38.10%)  8
Gastrointestinal disorders   
Anorexia  1  8/21 (38.10%)  8
Taste Changes  1  4/21 (19.05%)  4
Diarrhea  1  17/21 (80.95%)  17
Oral Cavity Pain  1  13/21 (61.90%)  13
Mucositis  1  10/21 (47.62%)  10
Flatulence  1  8/21 (38.10%)  8
Abdominal pain or cramping  1  6/21 (28.57%)  6
Abdominal bloating  1  4/21 (19.05%)  4
Heartburn  1  2/21 (9.52%)  2
General disorders   
Weight loss  1  10/21 (47.62%)  10
Fatigue  1  7/21 (33.33%)  7
Nausea  1  3/21 (14.29%)  3
Infections and infestations   
Infection  1  6/21 (28.57%)  6
Injury, poisoning and procedural complications   
Thrombocytopenia  1  11/21 (52.38%)  11
Investigations   
Leukopenia  1  11/21 (52.38%)  11
Neutropenia  1  7/21 (33.33%)  7
Lymphopenia  1  3/21 (14.29%)  3
AST  1  9/21 (42.86%)  9
LDH  1  13/21 (61.90%)  13
ALT  1  8/21 (38.10%)  8
Bilirubin  1  4/21 (19.05%)  4
Alkaline phosphatase  1  3/21 (14.29%)  3
Metabolism and nutrition disorders   
Hypophosphatemia  1  12/21 (57.14%)  12
Hypocalcemia  1  12/21 (57.14%)  12
Hyponatremia  1  12/21 (57.14%)  12
Hyperglycemia  1  4/21 (19.05%)  4
Musculoskeletal and connective tissue disorders   
Muscle pain or cramping  1  11/21 (52.38%)  11
Joint pain  1  9/21 (42.86%)  9
Scalp pain  1  7/21 (33.33%)  7
Nervous system disorders   
Dizziness  1  3/21 (14.29%)  3
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  3/21 (14.29%)  3
Hoarseness  1  3/21 (14.29%)  3
Skin and subcutaneous tissue disorders   
HFSR  1 [1]  19/21 (90.48%)  19
Alopecia  1  16/21 (76.19%)  16
Rash  1  14/21 (66.67%)  14
Nail Changes  1  10/21 (47.62%)  10
Dry skin/scalp  1  10/21 (47.62%)  10
Skin lesions/sores  1 [2]  8/21 (38.10%)  8
Scalp pruritis  1  7/21 (33.33%)  7
Photosensitivity  1  3/21 (14.29%)  3
Vascular disorders   
Hypertension  1  11/21 (52.38%)  11
Flushing  1  9/21 (42.86%)  9
1
Term from vocabulary, CTCAE version 3.0
Indicates events were collected by systematic assessment
[1]
hand-foot-skin reaction
[2]
non HFSR
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Manisha Shah, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8629
EMail: Manisha.Shah@osumc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390325    
Obsolete Identifiers: NCT01645631
Other Study ID Numbers: NCI-2009-00196
NCI-2009-00196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006C0050
NCI-7609
CDR0000507441
OSU 06054 / IRB 2006C0050
7609 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
7609 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: May 8, 2018
Results First Posted: December 21, 2018
Last Update Posted: November 12, 2020