Trial Outcomes & Findings for Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC (NCT NCT00787267)
NCT ID: NCT00787267
Last Updated: 2016-06-30
Results Overview
Tumor response rate was defined by RECIST criteria: CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = 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
TERMINATED
PHASE2
37 participants
2 years
2016-06-30
Participant Flow
This study opened to enrollment in November 2008 and closed in October 2011 due to slow accrual. Subjects were enrolled at 3 sites: Duke University Medical Center, Durham VA Medical Center, and the University of Minnesota. All subjects were enrolled in Stage 1, in which prior knowledge of each subject's tumoral Src-activity was not known.
Participant milestones
| Measure |
Dasatinib
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Dasatinib
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Overall Study
Screen failure/Ineligible
|
10
|
|
Overall Study
No Reason Provided
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Dasatinib
n=37 Participants
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Unable to determine the response for 9 subjects.
Tumor response rate was defined by RECIST criteria: CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = 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
Outcome measures
| Measure |
Dasatinib
n=16 Participants
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Tumor Response
Complete Response
|
0 participants
|
|
Tumor Response
Partial Response
|
0 participants
|
|
Tumor Response
Stable Disease
|
5 participants
|
|
Tumor Response
Progression of Disease
|
11 participants
|
SECONDARY outcome
Timeframe: Progression and survival every 6 monthsPopulation: All subjects who received at least one dose of dasatinib were included in the analysis.
Overall survival (OS) is the duration from date of consent to date of death from any cause.
Outcome measures
| Measure |
Dasatinib
n=25 Participants
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Overall Survival
|
3.7 months
Interval 2.3 to 5.9
|
SECONDARY outcome
Timeframe: Duration of dasatinib treatment plus 30 daysPopulation: All subjects who received at least one dose of dasatinib were included in the analysis.
Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.
Outcome measures
| Measure |
Dasatinib
n=25 Participants
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
Grade 3-5 Toxicity Associated With Dasatinib Treatment
|
12 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Assays were not run because no objective tumor response was observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Assays were not run because no objective tumor response was observed.
Outcome measures
Outcome data not reported
Adverse Events
Evalulable Patients That Received Dasatinib
Serious adverse events
| Measure |
Evalulable Patients That Received Dasatinib
n=25 participants at risk
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
General disorders
anorexia
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
decreased hemoglobin
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
decreased leukocytes
|
4.0%
1/25
|
|
General disorders
dehydration
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
24.0%
6/25
|
|
General disorders
fatigue
|
20.0%
5/25
|
|
General disorders
hyponatremia - metabolic/lab
|
4.0%
1/25
|
|
General disorders
muscle weakness (generalized)
|
4.0%
1/25
|
|
Gastrointestinal disorders
nausea
|
8.0%
2/25
|
|
General disorders
neuro-motor (generalized weakness)
|
4.0%
1/25
|
|
General disorders
pericardial effusion
|
4.0%
1/25
|
|
Gastrointestinal disorders
vomiting
|
4.0%
1/25
|
Other adverse events
| Measure |
Evalulable Patients That Received Dasatinib
n=25 participants at risk
Dasatinib: 70 mg PO twice daily until progression.
|
|---|---|
|
General disorders
anorexia
|
24.0%
6/25
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm (wheezing)
|
8.0%
2/25
|
|
Blood and lymphatic system disorders
decreased hemoglobin
|
32.0%
8/25
|
|
Blood and lymphatic system disorders
decreased neutrophils
|
4.0%
1/25
|
|
Gastrointestinal disorders
diarrhea
|
12.0%
3/25
|
|
General disorders
dizziness (lightheadedness)
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.0%
2/25
|
|
General disorders
edema (periorbital/face)
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
elevated AST
|
8.0%
2/25
|
|
Renal and urinary disorders
elevated creatinine
|
4.0%
1/25
|
|
General disorders
elevated LDH
|
4.0%
1/25
|
|
General disorders
fatigue
|
32.0%
8/25
|
|
Gastrointestinal disorders
flatulence
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
hair loss (alopecia)
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
4.0%
1/25
|
|
General disorders
insomnia
|
4.0%
1/25
|
|
General disorders
leukocytosis
|
4.0%
1/25
|
|
General disorders
muscle weakness - lower extremity (leg weakness)
|
4.0%
1/25
|
|
General disorders
muscle weakness (generalized)
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
myalgias (generalized)
|
4.0%
1/25
|
|
Gastrointestinal disorders
nausea
|
24.0%
6/25
|
|
Blood and lymphatic system disorders
neutrophils (neutropenia)
|
4.0%
1/25
|
|
General disorders
pain extremity (legs)
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
pain-joint
|
4.0%
1/25
|
|
General disorders
pedal edema
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion, bilateral
|
4.0%
1/25
|
|
Cardiac disorders
pulmonary edema
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
rash
|
24.0%
6/25
|
|
Renal and urinary disorders
renal/genitourinary other (slow starting urinary stream)
|
4.0%
1/25
|
|
Gastrointestinal disorders
taste alteration
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
ulcers (scrotal)
|
4.0%
1/25
|
|
Gastrointestinal disorders
vomiting
|
8.0%
2/25
|
|
General disorders
weight loss
|
8.0%
2/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place