Trial Outcomes & Findings for Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer (NCT NCT00126568)
NCT ID: NCT00126568
Last Updated: 2018-01-19
Results Overview
Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, x-ray) or as \>10 mm with spiral CT scan.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
at 6 months after treatment
Results posted on
2018-01-19
Participant Flow
Subjects recruited from June 2005 to April 2011 from medical clinics
Participant milestones
| Measure |
BAY 43-9006
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
BAY 43-9006
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
BAY 43-9006
n=20 Participants
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 months after treatmentPopulation: All patients that received at least one cycle of treatment
Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, x-ray) or as \>10 mm with spiral CT scan.
Outcome measures
| Measure |
BAY 43-9006
n=18 Participants
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Number of Patients With Response to Treatment Measured by RECIST Criteria
Stable Disease
|
5 participants
|
|
Number of Patients With Response to Treatment Measured by RECIST Criteria
Progressive Disease
|
11 participants
|
|
Number of Patients With Response to Treatment Measured by RECIST Criteria
Partial Response
|
2 participants
|
SECONDARY outcome
Timeframe: 27 monthsPopulation: All patients on study
Outcome measures
| Measure |
BAY 43-9006
n=20 Participants
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.
|
1.9 months
Interval 1.3 to 3.6
|
SECONDARY outcome
Timeframe: 27 monthsPopulation: All patients on study.
Outcome measures
| Measure |
BAY 43-9006
n=20 Participants
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.
|
3.9 months
Interval 2.2 to 7.1
|
SECONDARY outcome
Timeframe: 27 monthsPopulation: Any participant that received treatment was analyzed for adverse events. Detailed information is reported in the Adverse Events data table.
The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.
Outcome measures
| Measure |
BAY 43-9006
n=20 Participants
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006
|
20 Participants
|
Adverse Events
BAY 43-9006
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAY 43-9006
n=20 participants at risk
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
General disorders
Death not associated with CTCAE term - Death NOS(not otherwise specified)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS(not otherwise specified)
|
15.0%
3/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.0%
2/20 • Number of events 7 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Edema: limb
|
5.0%
1/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with unknown ANC(Absolute neutrophil count) - Lung (pneumonia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS(not otherwise specified)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Eye disorders
Pain - Eye
|
5.0%
1/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Perforation, GI - Appendix
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
Other adverse events
| Measure |
BAY 43-9006
n=20 participants at risk
BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
|
|---|---|
|
Metabolism and nutrition disorders
ALT(Alanine transaminase), SGPT (serum glutamic pyruvic transaminase)
|
15.0%
3/20 • Number of events 8 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
AST(aspartate aminotransferase), SGOT(serum glutamic oxaloacetic transaminase)
|
20.0%
4/20 • Number of events 7 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
40.0%
8/20 • Number of events 22 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.0%
4/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Anorexia
|
30.0%
6/20 • Number of events 6 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.0%
1/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
40.0%
8/20 • Number of events 34 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Cervical spine-range of motion
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • Number of events 8 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
10.0%
2/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.0%
9/20 • Number of events 10 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Creatinine
|
20.0%
4/20 • Number of events 6 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
10.0%
2/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Diarrhea
|
45.0%
9/20 • Number of events 20 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.0%
6/20 • Number of events 7 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
35.0%
7/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
30.0%
6/20 • Number of events 12 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Edema: limb
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
70.0%
14/20 • Number of events 18 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Fever (in the absence of neutropenia)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
25.0%
5/20 • Number of events 6 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
50.0%
10/20 • Number of events 28 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
10.0%
2/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.0%
5/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.0%
14/20 • Number of events 33 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Lower GI NOS(not otherwise specified)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS(not otherwise specified)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Larynx
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS(not otherwise specified)
|
10.0%
2/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Cardiac disorders
Hypertension
|
20.0%
4/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
10.0%
2/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Pharynx
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with normal ANC(Absolute Neutrophil) or Grade 1 or 2 neutrophils - Upper aerodigestive NOS
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Upper airway NOS
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Urinary tract NOS
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Infections and infestations
Infection with normal ANC(Absolute Neutrophil Count) or Grade 1 or 2 neutrophils - Vagina
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Leukocytes (total White Blood Count)
|
35.0%
7/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
80.0%
16/20 • Number of events 77 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
15.0%
3/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Nervous system disorders
Mood alteration - Depression
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
35.0%
7/20 • Number of events 7 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.0%
1/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 11 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Nervous system disorders
Neuropathy: sensory
|
40.0%
8/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC(absolute neutrophil count)/AGC(absolute granulocyte count)
|
10.0%
2/20 • Number of events 8 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway - Trachea
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
15.0%
3/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain
|
15.0%
3/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Abdomen NOS (not otherwise specified)
|
5.0%
1/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Back
|
30.0%
6/20 • Number of events 7 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Chest/thorax NOS (not otherwise specified)
|
40.0%
8/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Extremity-limb
|
10.0%
2/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Face
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Head/headache
|
20.0%
4/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
10.0%
2/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
15.0%
3/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Neck
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Oral cavity
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Pelvis
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Scrotum
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Stomach
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Throat/pharynx/larynx
|
20.0%
4/20 • Number of events 4 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Pain - Tumor pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Eye disorders
Pain-Eye
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Perforation, GI - Appendix
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
25.0%
5/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Blood and lymphatic system disorders
Platelets
|
20.0%
4/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
25.0%
5/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
15.0%
3/20 • Number of events 23 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.0%
3/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
10/20 • Number of events 23 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Radiation
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
30.0%
6/20 • Number of events 13 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Rigors/chills
|
10.0%
2/20 • Number of events 3 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
55.0%
11/20 • Number of events 22 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
5.0%
1/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI - Pharynx
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
30.0%
6/20 • Number of events 9 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
General disorders
Sweating (diaphoresis)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
25.0%
5/20 • Number of events 5 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Eye disorders
Vision-flashing lights/floaters
|
5.0%
1/20 • Number of events 1 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
40.0%
8/20 • Number of events 11 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 10 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
|
Investigations
Weight loss
|
45.0%
9/20 • Number of events 15 • Adverse events were collected weekly for the duration that the patients started on treatment to end of study.
|
Additional Information
Dr. Panayiotis Savvides
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-5946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60