Clinical trial · Interventional
Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
NCT00544908CI-TRIAL-00019334terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity
Summary
Brief summary (as posted)
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib | Drug | Dasatinib | ALIAS |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib
- description
- Dasatinib 70 mg po bid (1 cycle=28 days)
- interventionNames
- Drug: dasatinib
- Other: immunoenzyme technique
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) Rate at 4 Months
- timeFrame
- Four months.
- description
- 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).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically\* confirmed pancreatic cancer * Stage IV disease NOTE: \*If biopsy was performed at an outside facility, the histology must be reviewed and confirmed by the Division of Pathology at the City of Hope PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 3 months * Platelet count ≥ 100,000/μL * Absolute neutrophil count ≥ 1,500/μL * Bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 mg/dL and/or creatinine clearance \> 60 mL/min * PT and PTT ≤ 1.5 times ULN * Able to swallow dasatinib whole * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder * No concurrent medical condition which may increase the risk of toxicity, including any of the following: * Pleural or pericardial effusion of any grade * Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease) * None of the following cardiac conditions: * Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months * Prolonged QTc interval (i.e., QTc \> 450 msec) on electrocardiogram * History of clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) * No hypokalemia or hypomagnesemia that cannot be corrected * No severe infection requiring treatment * Completely recovered from other concurrent illnesses, as deemed by the investigator * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * Recovered from prior major surgery * No prior irradiation to the planned field * No prior chemotherapy for pancreatic cancer * At least 7 days since prior and no concurrent medications that may prolong the QT interval, including any of the following: * Quinidine * Procainamide * Disopyramide * Amiodarone * Sotalol * Ibutilide * Dofetilide * Erythromycin * Clarithromycin * Chlorpromazine * Haloperidol * Mesoridazine * Thioridazine * Pimozide * Cisapride * Bepridil * Droperidol * Methadone * Arsenic * Chloroquine * Domperidone * Halofantrine * Levomethadyl * Pentamidine * Sparfloxacin * Lidoflazine * At least 7 days since prior and no concurrent potent CYP3A4 inhibitors * At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following: * Aspirin or aspirin-containing combinations * Clopidogrel * Dipyridamole * Tirofiban * Dipyridamole * Epoprostenol * Eptifibatide * Cilostazol * Abciximab * Ticlopidine * Cilostazol * No concurrent anticoagulants, including warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin) * Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for flushes of IV lines allowed * No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy * No concurrent Hypericum perforatum (St. Johns wort)
References
Publications (0)
Data not yet available
No reference posted for this study.