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Trial record 4 of 360 for:    "Malignant mesothelioma"

Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

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ClinicalTrials.gov Identifier: NCT00509041
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : January 17, 2013
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Mesothelioma
Intervention Drug: dasatinib
Enrollment 46
Recruitment Details Between September 2007 to August 2009, 46 participants were recruited.
Pre-assignment Details Three (3) participants withdrew from the study before treatment initiation; therefore 43 participants were eligible for evaluation
Arm/Group Title Dasatinib
Hide Arm/Group Description Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title Dasatinib
Hide Arm/Group Description Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
68
(35 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
12
  27.9%
Male
31
  72.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
ECOG Performance Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
0 - Fully Active 19
1 - Ambulatory, restricted strenuous activity 24
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
Site of origin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Pleura 36
Peritoneum 6
Other 1
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Epithelial 33
Biphasic 5
Sarcomatoid 2
Not reported 3
Prior chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Yes 43
No 0
Prior radiation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Yes 6
No 37
Prior surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
Yes 23
No 20
1.Primary Outcome
Title 24 Week Progression Free Survival
Hide Description 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.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(13.5 to 40)
2.Secondary Outcome
Title Number of Participants With Overall Tumor Response
Hide Description

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.

Time Frame Duration of study until progression (up to 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 2
3.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Time from registration to death (up to 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Overall Number of Participants Analyzed 43
Median (95% Confidence Interval)
Unit of Measure: weeks
26.1
(18.6 to 36.7)
4.Secondary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame Time from registration to progression or death (up to 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
Overall Number of Participants Analyzed 43
Median (95% Confidence Interval)
Unit of Measure: weeks
9.1
(7.4 to 16.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dasatinib
Hide Arm/Group Description Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
All-Cause Mortality
Dasatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib
Affected / at Risk (%) # Events
Total   15/43 (34.88%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  8/43 (18.60%)  11
Cardiac disorders   
Pericardial effusion  1  2/43 (4.65%)  2
Eye disorders   
Watering eyes  1  1/43 (2.33%)  1
Gastrointestinal disorders   
Abdominal distension  1  2/43 (4.65%)  2
Abdominal pain  1  2/43 (4.65%)  2
Constipation  1  5/43 (11.63%)  5
Diarrhea  1  7/43 (16.28%)  7
Dry mouth  1  1/43 (2.33%)  1
Dyspepsia  1  1/43 (2.33%)  1
Flatulence  1  1/43 (2.33%)  1
Hemorrhoids  1  1/43 (2.33%)  1
Nausea  1  7/43 (16.28%)  8
Peritoneal pain  1  1/43 (2.33%)  1
Small intestinal obstruction  1  1/43 (2.33%)  1
Vomiting  1  4/43 (9.30%)  4
General disorders   
Chest pain  1  3/43 (6.98%)  3
Chills  1  1/43 (2.33%)  1
Disease progression  1  1/43 (2.33%)  1
Edema limbs  1  3/43 (6.98%)  3
Fatigue  1  10/43 (23.26%)  13
Fever  1  1/43 (2.33%)  1
Injection site reaction  1  1/43 (2.33%)  1
Localized edema  1  1/43 (2.33%)  1
Sudden death  1  1/43 (2.33%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  1/43 (2.33%)  1
Pleural infection  1  1/43 (2.33%)  1
Pneumonia  1  3/43 (6.98%)  3
Sinusitis  1  1/43 (2.33%)  1
Investigations   
Alanine aminotransferase increased  1  2/43 (4.65%)  2
Alkaline phosphatase increased  1  2/43 (4.65%)  2
Aspartate aminotransferase increased  1  3/43 (6.98%)  3
Creatinine increased  1  3/43 (6.98%)  3
INR increased  1  1/43 (2.33%)  1
Leukocyte count decreased  1  1/43 (2.33%)  1
Lymphocyte count decreased  1  3/43 (6.98%)  4
Weight loss  1  4/43 (9.30%)  4
Metabolism and nutrition disorders   
Anorexia  1  6/43 (13.95%)  6
Blood glucose increased  1  4/43 (9.30%)  4
Dehydration  1  2/43 (4.65%)  2
Serum albumin decreased  1  7/43 (16.28%)  8
Serum calcium decreased  1  6/43 (13.95%)  7
Serum glucose decreased  1  1/43 (2.33%)  1
Serum magnesium increased  1  2/43 (4.65%)  2
Serum potassium decreased  1  1/43 (2.33%)  1
Serum potassium increased  1  2/43 (4.65%)  2
Serum sodium decreased  1  6/43 (13.95%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/43 (6.98%)  3
Back pain  1  1/43 (2.33%)  1
Myalgia  1  2/43 (4.65%)  2
Pain in extremity  1  1/43 (2.33%)  1
Nervous system disorders   
Dizziness  1  1/43 (2.33%)  1
Dysgeusia  1  2/43 (4.65%)  2
Headache  1  1/43 (2.33%)  1
Peripheral motor neuropathy  1  2/43 (4.65%)  2
Peripheral sensory neuropathy  1  1/43 (2.33%)  1
Psychiatric disorders   
Confusion  1  1/43 (2.33%)  1
Insomnia  1  1/43 (2.33%)  1
Psychosis  1  2/43 (4.65%)  2
Renal and urinary disorders   
Glomerular filtration rate decreased  1  1/43 (2.33%)  1
Urogenital disorder  1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  1/43 (2.33%)  1
Allergic rhinitis  1  1/43 (2.33%)  1
Cough  1  3/43 (6.98%)  3
Dyspnea  1  5/43 (11.63%)  6
Hypoxia  1  1/43 (2.33%)  1
Pleural effusion  1  4/43 (9.30%)  4
Pleuritic pain  1  1/43 (2.33%)  1
Pneumonitis  1  1/43 (2.33%)  1
Respiratory disorder  1  1/43 (2.33%)  1
Skin and subcutaneous tissue disorders   
Rash desquamating  1  1/43 (2.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dasatinib
Affected / at Risk (%) # Events
Total   35/43 (81.40%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  24/43 (55.81%)  64
Cardiac disorders   
Pericardial effusion  1  1/43 (2.33%)  1
Pericarditis  1  1/43 (2.33%)  1
Ventricular tachycardia  1  1/43 (2.33%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/43 (2.33%)  1
Abdominal pain  1  4/43 (9.30%)  4
Ascites  1  1/43 (2.33%)  1
Constipation  1  4/43 (9.30%)  5
Diarrhea  1  14/43 (32.56%)  19
Dyspepsia  1  3/43 (6.98%)  3
Gastritis  1  1/43 (2.33%)  1
Gastrointestinal disorder  1  1/43 (2.33%)  1
Hemorrhoids  1  1/43 (2.33%)  1
Nausea  1  11/43 (25.58%)  19
Stomach pain  1  1/43 (2.33%)  2
Vomiting  1  6/43 (13.95%)  9
General disorders   
Chest pain  1  3/43 (6.98%)  5
Chills  1  3/43 (6.98%)  3
Disease progression  1  2/43 (4.65%)  2
Edema limbs  1  2/43 (4.65%)  7
Fatigue  1  24/43 (55.81%)  57
Fever  1  4/43 (9.30%)  5
Injection site reaction  1  1/43 (2.33%)  1
Localized edema  1  1/43 (2.33%)  2
Pain  1  1/43 (2.33%)  1
Visceral edema  1  1/43 (2.33%)  1
Immune system disorders   
Hypersensitivity  1  1/43 (2.33%)  1
Infections and infestations   
Gingival infection  1  1/43 (2.33%)  1
Pneumonia  1  1/43 (2.33%)  1
Rhinitis infective  1  1/43 (2.33%)  2
Sinusitis  1  1/43 (2.33%)  2
Upper aerodigestive tract infection  1  1/43 (2.33%)  3
Injury, poisoning and procedural complications   
Arterial injury  1  1/43 (2.33%)  1
Investigations   
Alanine aminotransferase increased  1  2/43 (4.65%)  5
Alkaline phosphatase increased  1  2/43 (4.65%)  6
Aspartate aminotransferase increased  1  3/43 (6.98%)  6
Creatinine increased  1  1/43 (2.33%)  1
Electrocardiogram QTc interval prolonged  1  1/43 (2.33%)  1
INR increased  1  1/43 (2.33%)  1
Leukocyte count decreased  1  1/43 (2.33%)  1
Lymphocyte count decreased  1  6/43 (13.95%)  9
Platelet count decreased  1  3/43 (6.98%)  3
Weight loss  1  7/43 (16.28%)  18
Metabolism and nutrition disorders   
Anorexia  1  11/43 (25.58%)  13
Blood glucose increased  1  6/43 (13.95%)  10
Dehydration  1  1/43 (2.33%)  1
Serum albumin decreased  1  5/43 (11.63%)  6
Serum calcium decreased  1  4/43 (9.30%)  4
Serum calcium increased  1  1/43 (2.33%)  1
Serum glucose decreased  1  1/43 (2.33%)  1
Serum magnesium decreased  1  1/43 (2.33%)  1
Serum magnesium increased  1  1/43 (2.33%)  1
Serum phosphate decreased  1  4/43 (9.30%)  4
Serum potassium decreased  1  2/43 (4.65%)  4
Serum potassium increased  1  1/43 (2.33%)  1
Serum sodium decreased  1  10/43 (23.26%)  10
Serum sodium increased  1  1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/43 (4.65%)  3
Back pain  1  3/43 (6.98%)  4
Bone pain  1  1/43 (2.33%)  1
Chest wall pain  1  5/43 (11.63%)  5
Pain in extremity  1  1/43 (2.33%)  1
Nervous system disorders   
Dizziness  1  3/43 (6.98%)  7
Dysgeusia  1  2/43 (4.65%)  3
Headache  1  8/43 (18.60%)  10
Memory impairment  1  1/43 (2.33%)  1
Neurological disorder NOS  1  1/43 (2.33%)  1
Peripheral sensory neuropathy  1  3/43 (6.98%)  3
Psychiatric disorders   
Anxiety  1  1/43 (2.33%)  1
Confusion  1  1/43 (2.33%)  1
Depression  1  1/43 (2.33%)  1
Insomnia  1  3/43 (6.98%)  3
Renal and urinary disorders   
Urogenital disorder  1  1/43 (2.33%)  6
Reproductive system and breast disorders   
Breast pain  1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/43 (4.65%)  4
Cough  1  6/43 (13.95%)  16
Dyspnea  1  19/43 (44.19%)  40
Epistaxis  1  1/43 (2.33%)  1
Hypoxia  1  2/43 (4.65%)  3
Pleural effusion  1  8/43 (18.60%)  18
Pneumonitis  1  1/43 (2.33%)  2
Respiratory disorder  1  1/43 (2.33%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/43 (2.33%)  1
Pruritus  1  2/43 (4.65%)  2
Rash acneiform  1  2/43 (4.65%)  2
Rash desquamating  1  4/43 (9.30%)  7
Skin disorder  1  2/43 (4.65%)  2
Vascular disorders   
Thrombosis  1  2/43 (4.65%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Arkadiusz Dudek, MD, PhD
Organization: University of Minnesota Masonic Cancer Center
Publications of Results:
Dudek A, Pang H, Kratzke RA, et al.: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM). [Abstract] J Clin Oncol 28 (Suppl 15) A-7037, 2010.
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00509041     History of Changes
Other Study ID Numbers: CALGB-30601
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-30601
CDR0000558362 ( Registry Identifier: NCI Physician Data Query )
First Submitted: July 30, 2007
First Posted: July 31, 2007
Results First Submitted: December 11, 2012
Results First Posted: January 17, 2013
Last Update Posted: August 11, 2016