Trial Outcomes & Findings for Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00459342)
NCT ID: NCT00459342
Last Updated: 2019-03-05
Results Overview
Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-03-05
Participant Flow
Recruitment Period: March 22, 2007 to April 20, 2009. All recruitment done at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Dasatinib
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dasatinib
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Not eligible
|
1
|
Baseline Characteristics
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib
n=35 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Of the 34 eligible study participants enrolled, four participants were not evaluable for response.
Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
Outcome measures
| Measure |
Dasatinib
n=30 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
Partial Remission
|
1 participants
|
|
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
Stable Disease
|
12 participants
|
|
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
Progressive Disease
|
17 participants
|
PRIMARY outcome
Timeframe: Time from start of treatment to time of progression or death, assessed at 2 monthsPopulation: Four participants were not evaluable for response.
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.
Outcome measures
| Measure |
Dasatinib
n=30 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival (PFS)
|
1.36 months
Interval 0.16 to 17.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from start of treatment to time of progression or death, assessed radiographically every 6 weeksPopulation: Seven patients discontinued dasatinib because of toxicity or unrelated medical problems (i.e., not progression) and are not evaluable for progression.
Outcome measures
| Measure |
Dasatinib
n=27 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Progression (TTP)
|
92 days
Standard Deviation 107
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Dasatinib
n=34 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Epidermal Growth Factor Receptor (EGFR) Mutational Status
EGFR mutant
|
9 participants
|
|
Epidermal Growth Factor Receptor (EGFR) Mutational Status
EGFR wild type
|
22 participants
|
|
Epidermal Growth Factor Receptor (EGFR) Mutational Status
EGFR not tested
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Dasatinib
n=34 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Epidermal Growth Factor Receptor (EGFR) Copy Number
EGFR amplfied
|
3 participants
|
|
Epidermal Growth Factor Receptor (EGFR) Copy Number
EGFR not amplified
|
17 participants
|
|
Epidermal Growth Factor Receptor (EGFR) Copy Number
EGFR copy number unknown
|
14 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Dasatinib
n=34 Participants
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Phospho-Src (pSrc) Expression
pSrc positive
|
10 participants
|
|
Phospho-Src (pSrc) Expression
pSrc negative
|
11 participants
|
|
Phospho-Src (pSrc) Expression
pSrc unknown
|
13 participants
|
Adverse Events
Dasatinib
Serious events: 25 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib
n=35 participants at risk
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
15/35 • Number of events 17 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
17.1%
6/35 • Number of events 6 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
8.6%
3/35 • Number of events 4 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Hypoxia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Death NOS
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Headache
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
Other adverse events
| Measure |
Dasatinib
n=35 participants at risk
Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Abdominal pain
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Immune system disorders
Allergic rhinitis
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Anemia
|
17.1%
6/35 • Number of events 9 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.7%
16/35 • Number of events 17 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Psychiatric disorders
Anxiety
|
17.1%
6/35 • Number of events 7 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Endocrine disorders
Aspartate aminotransferase increased
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Back pain
|
17.1%
6/35 • Number of events 6 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Renal and urinary disorders
Bladder infection
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Injury, poisoning and procedural complications
Burn
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Eye disorders
Conjunctivitis
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Constipation
|
22.9%
8/35 • Number of events 8 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
21/35 • Number of events 25 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Psychiatric disorders
Depression
|
14.3%
5/35 • Number of events 5 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
15/35 • Number of events 17 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Dysgeusia
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
3/35 • Number of events 4 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
21/35 • Number of events 32 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Edema face
|
11.4%
4/35 • Number of events 5 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Edema limbs
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Epistaxis
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Eye disorders
Eye pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Facial pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Fatigue
|
80.0%
28/35 • Number of events 39 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Infections and infestations
Fever
|
8.6%
3/35 • Number of events 5 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Gastritis
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Headache
|
25.7%
9/35 • Number of events 9 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
5/35 • Number of events 5 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Hypertension
|
14.3%
5/35 • Number of events 5 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Endocrine disorders
Hypoalbuminemia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Hypoxia
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Psychiatric disorders
Insomnia
|
20.0%
7/35 • Number of events 8 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
8.6%
3/35 • Number of events 4 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
31.4%
11/35 • Number of events 13 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
21/35 • Number of events 22 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Reproductive system and breast disorders
Nipple deformity
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Non-cardiac chest pain
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
General disorders
Pain
|
25.7%
9/35 • Number of events 10 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
51.4%
18/35 • Number of events 26 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.9%
8/35 • Number of events 9 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - (Other)
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.9%
1/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Stomach pain
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal obstruction
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.9%
1/35 • Number of events 3 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
1/35 • Number of events 1 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Renal and urinary disorders
Urinary tract infection
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Nervous system disorders
Voice alteration
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
7/35 • Number of events 7 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
|
Metabolism and nutrition disorders
Weight loss
|
5.7%
2/35 • Number of events 2 • 29 weeks
Treatment schedule included up to eight (8) possible 21-day (3-week) study cycles with follow up about 4-5 weeks after the last dose of Dasatinib.
|
Additional Information
Faye Johnson, MD / Associate Professor
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60