Trial Outcomes & Findings for Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery (NCT NCT00459108)

Last Updated: 2018-04-19

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

4 months

Results posted on

2018-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Dasatinib Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Overall Study STARTED	25
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Dasatinib Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Overall Study Withdrawal by Subject	5
Overall Study Adverse Event	3
Overall Study Death	2
Overall Study Progression	1

Baseline Characteristics

Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Response Rate (Complete and Partial Response)	0 percentage of responding patients

PRIMARY outcome

Timeframe: 4 months

Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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

Outcome measures
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Four Month Progression-free Survival (PFS)	40 percentage of participants Interval 21.0 to 58.0

SECONDARY outcome

Timeframe: Until disease progression or death, up to 4 years

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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

Outcome measures
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Median Progression-free Survival	3.7 Months Interval 1.8 to 6.4

SECONDARY outcome

Timeframe: Up to 4 years

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Overall Survival	7.5 Months Interval 2.9 to 13.6

SECONDARY outcome

Timeframe: Up to 4 years

Population: One patient died due to underlying cardiac disease which may have been exacerbated by the dasatanib.

Summarize observed grade 3 and higher toxicities related to dasatanib. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were used for reporting.

Outcome measures

Outcome measures
Measure	Oral Dasatinib n=25 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Safety and Tolerability Grade 3 : Edema:head and neck	1 participants
Safety and Tolerability Grade 3 : Fatigue (asthenia, lethargy, malaise)	8 participants
Safety and Tolerability Grade 4 : Nausea	0 participants
Safety and Tolerability Grade 4 : Pain - Head/headache	0 participants
Safety and Tolerability Grade 4 : Pain - Middle ear	0 participants
Safety and Tolerability Grade 4 : Phosphate, serum-low (hypophosphatemia)	0 participants
Safety and Tolerability Grade 4 : Platelets	0 participants
Safety and Tolerability Grade 4 : Potassium, serum-low (hypokalemia)	0 participants
Safety and Tolerability Grade 4 : Proteinuria	0 participants
Safety and Tolerability Grade 4 : Sodium, serum-low (hyponatremia)	0 participants
Safety and Tolerability Grade 3 : AST, SGOT	2 participants
Safety and Tolerability Grade 3 : Anorexia	2 participants
Safety and Tolerability Grade 3 : Sudden death	0 participants
Safety and Tolerability Grade 3 : Dehydration	2 participants
Safety and Tolerability Grade 3 : Diarrhea	1 participants
Safety and Tolerability Grade 3 : Dizziness	0 participants
Safety and Tolerability Grade 3 : Glucose, serum-high (hyperglycemia)	1 participants
Safety and Tolerability Grade 3 : Hemoglobin	2 participants
Safety and Tolerability Grade 3 : Hemorrhage, GI - Colon	1 participants
Safety and Tolerability Grade 3 : Hemorrhage, GI - Stomach	1 participants
Safety and Tolerability Grade 3 : Infection with normal ANC	1 participants
Safety and Tolerability Grade 3 : Leukocytes (total WBC)	1 participants
Safety and Tolerability Grade 3 : Lymphopenia	2 participants
Safety and Tolerability Grade 3 : Nausea	3 participants
Safety and Tolerability Grade 3 : Pain - Head/headache	2 participants
Safety and Tolerability Grade 3 : Pain - Middle ear	1 participants
Safety and Tolerability Grade 3 : Phosphate, serum-low (hypophosphatemia)	3 participants
Safety and Tolerability Grade 3 : Platelets	1 participants
Safety and Tolerability Grade 3 : Pneumonitis/pulmonary infiltrates	1 participants
Safety and Tolerability Grade 3 : Potassium, serum-low (hypokalemia)	1 participants
Safety and Tolerability Grade 3 : Proteinuria	1 participants
Safety and Tolerability Grade 3 : Sodium, serum-low (hyponatremia)	3 participants
Safety and Tolerability Grade 3 : Thrombotic microangiopathy	1 participants
Safety and Tolerability Grade 3 : Urinary retention	1 participants
Safety and Tolerability Grade 3 : Vomiting	3 participants
Safety and Tolerability Grade 4 : AST, SGOT	0 participants
Safety and Tolerability Grade 4 : Anorexia	0 participants
Safety and Tolerability Grade 4 : Sudden death	0 participants
Safety and Tolerability Grade 4 : Dehydration	0 participants
Safety and Tolerability Grade 4 : Diarrhea	0 participants
Safety and Tolerability Grade 4 : Dizziness	1 participants
Safety and Tolerability Grade 4 : Edema:head and neck	0 participants
Safety and Tolerability Grade 4 : Fatigue (asthenia, lethargy, malaise)	1 participants
Safety and Tolerability Grade 4 : Glucose, serum-high (hyperglycemia)	0 participants
Safety and Tolerability Grade 4 : Hemoglobin	1 participants
Safety and Tolerability Grade 4 : Hemorrhage, GI - Colon	0 participants
Safety and Tolerability Grade 4 : Hemorrhage, GI - Stomach	0 participants
Safety and Tolerability Grade 4 : Infection with normal ANC	0 participants
Safety and Tolerability Grade 4 : Leukocytes (total WBC)	0 participants
Safety and Tolerability Grade 4 : Lymphopenia	0 participants
Safety and Tolerability Grade 4 : Pneumonitis/pulmonary infiltrates	0 participants
Safety and Tolerability Grade 4 : Thrombotic microangiopathy	0 participants
Safety and Tolerability Grade 4 : Urinary retention	0 participants
Safety and Tolerability Grade 4 : Vomiting	0 participants
Safety and Tolerability Grade 5 : AST, SGOT	0 participants
Safety and Tolerability Grade 5 : Anorexia	0 participants
Safety and Tolerability Grade 5 : Sudden death	1 participants
Safety and Tolerability Grade 5 : Dehydration	0 participants
Safety and Tolerability Grade 5 : Diarrhea	0 participants
Safety and Tolerability Grade 5 : Dizziness	0 participants
Safety and Tolerability Grade 5 : Edema:head and neck	0 participants
Safety and Tolerability Grade 5 : Fatigue (asthenia, lethargy, malaise)	0 participants
Safety and Tolerability Grade 5 : Glucose, serum-high (hyperglycemia)	0 participants
Safety and Tolerability Grade 5 : Hemoglobin	0 participants
Safety and Tolerability Grade 5 : Hemorrhage, GI - Colon	0 participants
Safety and Tolerability Grade 5 : Hemorrhage, GI - Stomach	0 participants
Safety and Tolerability Grade 5 : Infection with normal ANC	0 participants
Safety and Tolerability Grade 5 : Leukocytes (total WBC)	0 participants
Safety and Tolerability Grade 5 : Lymphopenia	0 participants
Safety and Tolerability Grade 5 : Nausea	0 participants
Safety and Tolerability Grade 5 : Pain - Head/headache	0 participants
Safety and Tolerability Grade 5 : Pain - Middle ear	0 participants
Safety and Tolerability Grade 5 : Phosphate, serum-low (hypophosphatemia)	0 participants
Safety and Tolerability Grade 5 : Platelets	0 participants
Safety and Tolerability Grade 5 : Pneumonitis/pulmonary infiltrates	0 participants
Safety and Tolerability Grade 5 : Potassium, serum-low (hypokalemia)	0 participants
Safety and Tolerability Grade 5 : Proteinuria	0 participants
Safety and Tolerability Grade 5 : Sodium, serum-low (hyponatremia)	0 participants
Safety and Tolerability Grade 5 : Thrombotic microangiopathy	0 participants
Safety and Tolerability Grade 5 : Urinary retention	0 participants
Safety and Tolerability Grade 5 : Vomiting	0 participants

Adverse Events

Oral Dasatinib

Serious events: 13 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Dasatinib n=25 participants at risk Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Blood and lymphatic system disorders Hemoglobin decreased	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Blood and lymphatic system disorders Thrombotic microangiopathy	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Cardiac disorders Cardiopulmonary arrest	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Ascites	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Colonic hemorrhage	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Esophageal varices hemorrhage	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Gastric hemorrhage	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Death	12.0% 3/25 • Number of events 3 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Disease progression	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Fatigue	16.0% 4/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Fever	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Localized edema	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Sudden death	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Immune system disorders Hypersensitivity	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Injury, poisoning and procedural complications Vascular access complication	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Dehydration	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum calcium decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum phosphate decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum potassium decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Back pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Chest wall pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Joint pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Renal failure	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Reproductive system and breast disorders Prostatic hemorrhage	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.0% 4/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Vascular disorders Hypotension	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Vascular disorders Thrombosis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.

Other adverse events

Other adverse events
Measure	Oral Dasatinib n=25 participants at risk Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. dasatinib: Given orally
Blood and lymphatic system disorders Hemoglobin decreased	64.0% 16/25 • Number of events 43 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Blood and lymphatic system disorders Hemolysis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Ear and labyrinth disorders Ear pain	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Eye disorders Dry eye syndrome	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Eye disorders Eye disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Eye disorders Vision blurred	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Eye disorders Vitreous hemorrhage	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Abdominal distension	12.0% 3/25 • Number of events 5 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Abdominal pain	44.0% 11/25 • Number of events 18 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Ascites	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Constipation	20.0% 5/25 • Number of events 7 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Diarrhea	40.0% 10/25 • Number of events 16 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Dry mouth	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Dyspepsia	12.0% 3/25 • Number of events 3 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Dysphagia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Ear, nose and throat examination abnormal	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Esophageal pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Flatulence	8.0% 2/25 • Number of events 5 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Gastrointestinal disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Mucositis oral	16.0% 4/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Nausea	52.0% 13/25 • Number of events 26 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Salivary gland disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Gastrointestinal disorders Vomiting	32.0% 8/25 • Number of events 16 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Chest pain	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Chills	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Disease progression	64.0% 16/25 • Number of events 16 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Edema limbs	32.0% 8/25 • Number of events 10 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Fatigue	60.0% 15/25 • Number of events 41 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Fever	32.0% 8/25 • Number of events 12 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Localized edema	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
General disorders Pain	24.0% 6/25 • Number of events 9 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Hepatobiliary disorders Hepatic pain	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Immune system disorders Hypersensitivity	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Bronchitis	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Conjunctivitis infective	4.0% 1/25 • Number of events 3 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Infection	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Paranasal sinus infection	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Sinusitis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Infections and infestations Upper respiratory infection	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Activated partial thromboplastin time prolonged	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Alanine aminotransferase increased	56.0% 14/25 • Number of events 35 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Alkaline phosphatase increased	52.0% 13/25 • Number of events 25 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Aspartate aminotransferase increased	60.0% 15/25 • Number of events 40 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Bilirubin increased	24.0% 6/25 • Number of events 11 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Creatinine increased	28.0% 7/25 • Number of events 13 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Leukocyte count decreased	28.0% 7/25 • Number of events 18 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Lipase increased	8.0% 2/25 • Number of events 12 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Lymphocyte count decreased	24.0% 6/25 • Number of events 10 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Neutrophil count decreased	20.0% 5/25 • Number of events 15 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Platelet count decreased	40.0% 10/25 • Number of events 26 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Investigations Weight loss	8.0% 2/25 • Number of events 5 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Anorexia	48.0% 12/25 • Number of events 23 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Blood bicarbonate decreased	24.0% 6/25 • Number of events 15 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Blood glucose increased	36.0% 9/25 • Number of events 27 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Dehydration	20.0% 5/25 • Number of events 6 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum albumin decreased	28.0% 7/25 • Number of events 11 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum calcium decreased	36.0% 9/25 • Number of events 12 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum magnesium increased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum phosphate decreased	32.0% 8/25 • Number of events 14 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum potassium decreased	12.0% 3/25 • Number of events 3 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum potassium increased	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Metabolism and nutrition disorders Serum sodium decreased	48.0% 12/25 • Number of events 23 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Back pain	12.0% 3/25 • Number of events 7 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Buttock pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Chest wall pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Joint pain	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Dizziness	24.0% 6/25 • Number of events 7 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Headache	52.0% 13/25 • Number of events 21 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Peripheral sensory neuropathy	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Sinus pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Nervous system disorders Taste alteration	8.0% 2/25 • Number of events 3 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Psychiatric disorders Confusion	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Psychiatric disorders Depression	16.0% 4/25 • Number of events 5 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Psychiatric disorders Insomnia	16.0% 4/25 • Number of events 6 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Hemoglobin urine positive	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Protein urine positive	16.0% 4/25 • Number of events 13 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Urethral pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Urinary frequency	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Urinary incontinence	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Atelectasis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Cough	24.0% 6/25 • Number of events 13 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Dyspnea	32.0% 8/25 • Number of events 14 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	24.0% 6/25 • Number of events 17 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 1/25 • Number of events 5 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Skin and subcutaneous tissue disorders Dry skin	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Skin and subcutaneous tissue disorders Pruritus	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 5/25 • Number of events 8 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Skin and subcutaneous tissue disorders Rash desquamating	32.0% 8/25 • Number of events 14 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Skin and subcutaneous tissue disorders Sweating	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Vascular disorders Hypertension	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Vascular disorders Hypotension	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.
Vascular disorders Lymphedema	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 3 years, 3 months. "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse event table.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60