Trial Outcomes & Findings for Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma (NCT NCT00509041)
NCT ID: NCT00509041
Last Updated: 2016-08-11
Results Overview
Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
24 weeks
Results posted on
2016-08-11
Participant Flow
Between September 2007 to August 2009, 46 participants were recruited.
Three (3) participants withdrew from the study before treatment initiation; therefore 43 participants were eligible for evaluation
Participant milestones
| Measure |
Dasatinib
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Dasatinib
n=43 Participants
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
|
ECOG Performance Score
0 - Fully Active
|
19 participants
n=5 Participants
|
|
ECOG Performance Score
1 - Ambulatory, restricted strenuous activity
|
24 participants
n=5 Participants
|
|
Site of origin
Pleura
|
36 participants
n=5 Participants
|
|
Site of origin
Peritoneum
|
6 participants
n=5 Participants
|
|
Site of origin
Other
|
1 participants
n=5 Participants
|
|
Histology
Epithelial
|
33 participants
n=5 Participants
|
|
Histology
Biphasic
|
5 participants
n=5 Participants
|
|
Histology
Sarcomatoid
|
2 participants
n=5 Participants
|
|
Histology
Not reported
|
3 participants
n=5 Participants
|
|
Prior chemotherapy
Yes
|
43 participants
n=5 Participants
|
|
Prior chemotherapy
No
|
0 participants
n=5 Participants
|
|
Prior radiation
Yes
|
6 participants
n=5 Participants
|
|
Prior radiation
No
|
37 participants
n=5 Participants
|
|
Prior surgery
Yes
|
23 participants
n=5 Participants
|
|
Prior surgery
No
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPercentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
24 Week Progression Free Survival
|
23 percentage of participants
Interval 13.5 to 40.0
|
SECONDARY outcome
Timeframe: Duration of study until progression (up to 3 years)Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Number of Participants With Overall Tumor Response
Complete Response
|
0 participants
|
|
Number of Participants With Overall Tumor Response
Partial Response
|
2 participants
|
SECONDARY outcome
Timeframe: Time from registration to death (up to 3 years)Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Overall Survival
|
26.1 weeks
Interval 18.6 to 36.7
|
SECONDARY outcome
Timeframe: Time from registration to progression or death (up to 3 years)Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Dasatinib
n=43 Participants
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Progression Free Survival
|
9.1 weeks
Interval 7.4 to 16.9
|
Adverse Events
Dasatinib
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib
n=43 participants at risk
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
18.6%
8/43 • Number of events 11
|
|
Cardiac disorders
Pericardial effusion
|
4.7%
2/43 • Number of events 2
|
|
Eye disorders
Watering eyes
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
7/43 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.3%
7/43 • Number of events 8
|
|
Gastrointestinal disorders
Peritoneal pain
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
4/43 • Number of events 4
|
|
General disorders
Chest pain
|
7.0%
3/43 • Number of events 3
|
|
General disorders
Chills
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Disease progression
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Edema limbs
|
7.0%
3/43 • Number of events 3
|
|
General disorders
Fatigue
|
23.3%
10/43 • Number of events 13
|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Injection site reaction
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Localized edema
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Sudden death
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
7.0%
3/43 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
2/43 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 3
|
|
Investigations
Creatinine increased
|
7.0%
3/43 • Number of events 3
|
|
Investigations
INR increased
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
7.0%
3/43 • Number of events 4
|
|
Investigations
Weight loss
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
14.0%
6/43 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
2/43 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
16.3%
7/43 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
14.0%
6/43 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.7%
2/43 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.7%
2/43 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
14.0%
6/43 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
3/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
2/43 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
4.7%
2/43 • Number of events 2
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
2.3%
1/43 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.6%
5/43 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.3%
4/43 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.3%
1/43 • Number of events 1
|
Other adverse events
| Measure |
Dasatinib
n=43 participants at risk
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
55.8%
24/43 • Number of events 64
|
|
Cardiac disorders
Pericardial effusion
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
4/43 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.3%
4/43 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
32.6%
14/43 • Number of events 19
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.6%
11/43 • Number of events 19
|
|
Gastrointestinal disorders
Stomach pain
|
2.3%
1/43 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
6/43 • Number of events 9
|
|
General disorders
Chest pain
|
7.0%
3/43 • Number of events 5
|
|
General disorders
Chills
|
7.0%
3/43 • Number of events 3
|
|
General disorders
Disease progression
|
4.7%
2/43 • Number of events 2
|
|
General disorders
Edema limbs
|
4.7%
2/43 • Number of events 7
|
|
General disorders
Fatigue
|
55.8%
24/43 • Number of events 57
|
|
General disorders
Fever
|
9.3%
4/43 • Number of events 5
|
|
General disorders
Injection site reaction
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Localized edema
|
2.3%
1/43 • Number of events 2
|
|
General disorders
Pain
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Visceral edema
|
2.3%
1/43 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Rhinitis infective
|
2.3%
1/43 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • Number of events 2
|
|
Infections and infestations
Upper aerodigestive tract infection
|
2.3%
1/43 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arterial injury
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
2/43 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 6
|
|
Investigations
Creatinine increased
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
2.3%
1/43 • Number of events 1
|
|
Investigations
INR increased
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
2.3%
1/43 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
14.0%
6/43 • Number of events 9
|
|
Investigations
Platelet count decreased
|
7.0%
3/43 • Number of events 3
|
|
Investigations
Weight loss
|
16.3%
7/43 • Number of events 18
|
|
Metabolism and nutrition disorders
Anorexia
|
25.6%
11/43 • Number of events 13
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
14.0%
6/43 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.6%
5/43 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
4.7%
2/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
23.3%
10/43 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.6%
5/43 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.0%
3/43 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
4.7%
2/43 • Number of events 3
|
|
Nervous system disorders
Headache
|
18.6%
8/43 • Number of events 10
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.0%
3/43 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
7.0%
3/43 • Number of events 3
|
|
Renal and urinary disorders
Urogenital disorder
|
2.3%
1/43 • Number of events 6
|
|
Reproductive system and breast disorders
Breast pain
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.7%
2/43 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
6/43 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.2%
19/43 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.6%
8/43 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
9.3%
4/43 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.7%
2/43 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
4.7%
2/43 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place