Trial Outcomes & Findings for Dasatinib in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT00474812)
NCT ID: NCT00474812
Last Updated: 2015-05-05
Results Overview
From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
assessed up to 24 months
Results posted on
2015-05-05
Participant Flow
Patients were recruited from Cleveland, Ohio area hospitals, Case Medical Center University Hospitals and MetroHealth Medical Center.
Participant milestones
| Measure |
Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
No Initiation of treatment
|
2
|
Baseline Characteristics
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib Treatment
n=51 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed up to 24 monthsPopulation: Intent to treat.
From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months
Outcome measures
| Measure |
Dasatinib Treatment
n=51 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Median Overall Survival
|
4.7 months
Interval 2.8 to 6.9
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients that reached first scans at 2 months
Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.
Outcome measures
| Measure |
Dasatinib Treatment
n=34 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee
Progressive disease
|
24 participants
|
|
Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee
Stable Disease
|
10 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Intent to treat
Number of months patients were free of disease progression, defined as \< 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.
Outcome measures
| Measure |
Dasatinib Treatment
n=51 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
2.1 months
Interval 1.6 to 3.2
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants who were ambulatory at baseline
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Outcome measures
| Measure |
Dasatinib Treatment
n=17 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Gait Speed
|
4.1 meters per second
Standard Error 0.32
|
SECONDARY outcome
Timeframe: at 8 weeksPopulation: Participants who were ambulatory at 8 weeks
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Outcome measures
| Measure |
Dasatinib Treatment
n=10 Participants
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Gait Speed
|
4.6 meters per second
Standard Error 0.64
|
Adverse Events
Dasatinib Treatment
Serious events: 21 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib Treatment
n=51 participants at risk
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Cardiac disorders
Cardiac Troponin Increase
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Death not associated with CTCAE term - Death NOS (not otherwise specified)
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Fever
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Infections and infestations
Infections and infestations - Other, NOS
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Nervous system disorders
Nervous system disorders - Other, NOS
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Pain
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Cardiac disorders
Pericardial Effusion
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Infections and infestations
Sepsis
|
3.9%
2/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.9%
2/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Vascular disorders
Thromboembolic event
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
2/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
Other adverse events
| Measure |
Dasatinib Treatment
n=51 participants at risk
Patients receive oral dasatinib twice daily on days 1-28.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
34/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Agitation
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Alanine aminotransferase increased
|
52.9%
27/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
34/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Blood and lymphatic system disorders
Anemia
|
70.6%
36/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
34/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Anxiety
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Aspartate aminotransferase increased
|
68.6%
35/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.5%
13/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Blood bilirubin increased
|
21.6%
11/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Chills
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Confusion
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Constipation
|
45.1%
23/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Creatinine increased
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
29.4%
15/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Depression
|
21.6%
11/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Diarrhea
|
39.2%
20/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Nervous system disorders
Dizziness
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Nervous system disorders
Dysgeusia
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Dysphagia
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
9/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Edema face
|
17.6%
9/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Edema limbs
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Fatigue
|
76.5%
39/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
General disorders
Fever
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, NOS
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
23.5%
12/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Nervous system disorders
Headache
|
15.7%
8/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Vascular disorders
Hot flashes
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
51.0%
26/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Vascular disorders
Hypertension
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
60.8%
31/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
49.0%
25/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.3%
18/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.8%
31/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
INR increased
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Psychiatric disorders
Insomnia
|
35.3%
18/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Lymphocyte count decreased
|
51.0%
26/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
4/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Nausea
|
64.7%
33/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
5/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.6%
10/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Platelet count decreased
|
31.4%
16/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.7%
7/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.6%
11/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Vascular disorders
Thromboembolic event
|
5.9%
3/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Gastrointestinal disorders
Vomiting
|
49.0%
25/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
Weight loss
|
35.3%
18/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
|
Investigations
White blood cell decreased
|
23.5%
12/51 • Adverse Events that occur during treatment or within 30 Days of the last dose. The time frames for patients was 0-23 months.
|
Additional Information
Charles Nock MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-3862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60