Trial Outcomes & Findings for Dasatinib in Treating Patients With Stage IV Pancreatic Cancer (NCT NCT00544908)

Last Updated: 2015-10-05

Results Overview

Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Four months.

Results posted on

2015-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Dasatinib Dasatinib 70 mg po bid (1 cycle=28 days)
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=7 Participants Dasatinib 70 mg po bid (1 cycle=28 days)
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Four months.

Outcome measures

Outcome measures
Measure	Dasatinib n=7 Participants Dasatinib 70 mg po bid (1 cycle=28 days)
Progression-free Survival (PFS) Rate at 4 Months	0 percentage of participants

SECONDARY outcome

Timeframe: After every two cycles, up to 5 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Dasatinib n=7 Participants Dasatinib 70 mg po bid (1 cycle=28 days)
Response Rate	0 percentage of participants

Adverse Events

Dasatinib

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=7 participants at risk Dasatinib 70 mg po bid (1 cycle=28 days)
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Dehydration	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.

Other adverse events

Other adverse events
Measure	Dasatinib n=7 participants at risk Dasatinib 70 mg po bid (1 cycle=28 days)
Blood and lymphatic system disorders Hemoglobin decreased	71.4% 5/7 • Number of events 6 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Cardiac disorders Sinus bradycardia	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Eye disorders Vitreous hemorrhage	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Abdominal distension	28.6% 2/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Abdominal pain	71.4% 5/7 • Number of events 5 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 3 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Dry mouth	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Gastritis	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Ileus	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Nausea	42.9% 3/7 • Number of events 3 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Gastrointestinal disorders Vomiting	57.1% 4/7 • Number of events 4 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
General disorders Disease progression	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
General disorders Edema limbs	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
General disorders Fatigue	57.1% 4/7 • Number of events 5 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
General disorders Flu-like symptoms	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
General disorders Irritability	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Alanine aminotransferase increased	42.9% 3/7 • Number of events 4 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Alkaline phosphatase increased	57.1% 4/7 • Number of events 5 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Aspartate aminotransferase increased	57.1% 4/7 • Number of events 5 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Bilirubin increased	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Creatinine increased	57.1% 4/7 • Number of events 4 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Lymphocyte count decreased	28.6% 2/7 • Number of events 3 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Investigations Weight loss	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Acidosis	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Anorexia	42.9% 3/7 • Number of events 4 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Blood glucose increased	28.6% 2/7 • Number of events 3 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Dehydration	57.1% 4/7 • Number of events 4 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum albumin decreased	28.6% 2/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum calcium decreased	28.6% 2/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum magnesium increased	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum phosphate decreased	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum potassium decreased	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Metabolism and nutrition disorders Serum sodium decreased	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Musculoskeletal and connective tissue disorders Muscle weakness	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Nervous system disorders Dizziness	28.6% 2/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Psychiatric disorders Confusion	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Renal and urinary disorders Bladder hemorrhage	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Reproductive system and breast disorders Erectile dysfunction	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 2/7 • Number of events 2 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Skin and subcutaneous tissue disorders Decubitus ulcer	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Skin and subcutaneous tissue disorders Petechiae	14.3% 1/7 • Number of events 1 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.
Vascular disorders Hypotension	42.9% 3/7 • Number of events 3 • "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. Adverse events recorded over a period of 13 months.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place