Trial Outcomes & Findings for Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib (NCT NCT00609804)
NCT ID: NCT00609804
Last Updated: 2016-04-08
Results Overview
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
18 months
Results posted on
2016-04-08
Participant Flow
Participant milestones
| Measure |
Sorafenib+Erlotinib
Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib
Baseline characteristics by cohort
| Measure |
Sorafenib+Erlotinib
n=25 Participants
Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 Participants
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
63 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients on study
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Sorafenib+Erlotinib
n=25 Participants
Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 Participants
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.1 months
Interval 1.7 to 3.7
|
1.9 months
Interval 1.7 to 3.6
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients on study
The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Sorafenib+Erlotinib
n=25 Participants
Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 Participants
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
Overall Response Rate
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients on study
Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0
Outcome measures
| Measure |
Sorafenib+Erlotinib
n=25 Participants
Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 Participants
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Anemia
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Fatigue
|
4 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Diarrhea
|
4 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Dehydration
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Rash/Desquamation
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hand-foot skin reaction
|
2 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Dyspnea
|
3 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hyponatremia
|
2 participants
|
3 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hyperglycemia
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Lipase increased
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Anorexia
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Atrial Fibrillation
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Cognitive Disturbance
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Confusion
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Congestive Heart Failure
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Constipation
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Dysphagia
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Extremity - upper (function)
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hypertension
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Cardiac Ischemia/Infarction
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hypokalemia
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hypoxia
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Ileus
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Infection - Pneumonia
|
3 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Infection - Wound
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Malaise
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Nausea
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Obstruction, GI
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pain - abdomen
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pain - chest
|
2 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pain - musculoskeletal
|
1 participants
|
8 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Perforation, GI
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Vomiting
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Dizziness
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Infection - urinary tract NOS
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Neuropathy - cranial
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pain - back
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pain - head/headache
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
COPD exacerbation
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Ocular surgery
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Personality change
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Respiratory failure
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Pulmonary embolism
|
1 participants
|
0 participants
|
Adverse Events
Sorafenib+Erlotinib
Serious events: 11 serious events
Other events: 24 other events
Deaths: 0 deaths
Sorafenib
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib+Erlotinib
n=25 participants at risk
Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 participants at risk
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Cardiac disorders
Cardiac disorders - Other, unspecified
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Psychiatric disorders
Cognitive disturbance
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Cardiac disorders
Heart Failure
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
General disorders
Fatigue
|
8.0%
2/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Gastric perforation
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Ileus
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Psychiatric disorders
Personality change
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • 18 months
|
0.00%
0/28 • 18 months
|
Other adverse events
| Measure |
Sorafenib+Erlotinib
n=25 participants at risk
Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
Sorafenib
n=28 participants at risk
Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
|
|---|---|---|
|
General disorders
Fatigue
|
76.0%
19/25 • 18 months
|
50.0%
14/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
68.0%
17/25 • 18 months
|
53.6%
15/28 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
15/25 • 18 months
|
35.7%
10/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.0%
11/25 • 18 months
|
35.7%
10/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
10/25 • 18 months
|
35.7%
10/28 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25 • 18 months
|
35.7%
10/28 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
28.0%
7/25 • 18 months
|
35.7%
10/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
32.0%
8/25 • 18 months
|
32.1%
9/28 • 18 months
|
|
Investigations
Investigations - Other, unknown
|
40.0%
10/25 • 18 months
|
21.4%
6/28 • 18 months
|
|
Gastrointestinal disorders
abdominal pain
|
40.0%
10/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.0%
9/25 • 18 months
|
21.4%
6/28 • 18 months
|
|
General disorders
Non-cardiac chest pain
|
12.0%
3/25 • 18 months
|
39.3%
11/28 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.0%
7/25 • 18 months
|
21.4%
6/28 • 18 months
|
|
Blood and lymphatic system disorders
anemia
|
28.0%
7/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • 18 months
|
28.6%
8/28 • 18 months
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
3/25 • 18 months
|
25.0%
7/28 • 18 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
12.0%
3/25 • 18 months
|
25.0%
7/28 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • 18 months
|
21.4%
6/28 • 18 months
|
|
Investigations
Creatinine increased
|
20.0%
5/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Investigations
Platelet count decreased
|
24.0%
6/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
7/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Investigations
Weight loss
|
24.0%
6/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Investigations
White blood cell decreased
|
20.0%
5/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
5/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Psychiatric disorders
Insomnia
|
16.0%
4/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.0%
7/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
5/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Vascular disorders
Hypertension
|
16.0%
4/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.0%
4/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • 18 months
|
17.9%
5/28 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.0%
3/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
3/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
General disorders
Fever
|
4.0%
1/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Gastrointestinal disorders
Mucositis
|
8.0%
2/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.0%
2/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25 • 18 months
|
14.3%
4/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
3/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
12.0%
3/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.0%
3/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.0%
2/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Investigations
Lipase increased
|
12.0%
3/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, unknown
|
4.0%
1/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Investigations
Serum amylase increased
|
16.0%
4/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Infections and infestations
Bronchial infection
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Cardiac disorders
Cardiac disorders - Other, tachycardia
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
General disorders
Chills
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Psychiatric disorders
Confusion
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Nervous system disorders
Dysgeusia
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
dyspepsia
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.0%
3/25 • 18 months
|
0.00%
0/28 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Investigations
Investigations - Other, blood urea nitrogen increased
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/25 • 18 months
|
10.7%
3/28 • 18 months
|
|
Nervous system disorders
Nervous system disorders - Other, unknown
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, hemoptysis
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, skin changes
|
8.0%
2/25 • 18 months
|
3.6%
1/28 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
1/25 • 18 months
|
7.1%
2/28 • 18 months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER