Clinical trial · Interventional
Biological Effect of Warfarin on Pancreatic Cancer
NCT03536208CI-TRIAL-00050893withdrawnEarly Phase 1ClinicalTrials.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): no accrual for over 12 months
Summary
Brief summary (as posted)
This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Warfarin
- description
- Patients will be assigned to warfarin by mouth daily on an outpatient basis. Dose level will increase after 5 patients enrolled. Dose 1 = 1 mg warfarin; Dose 2 = 2 mg warfarin; Dose 3 = 2.5 mg warfarin; Dose 4 = 4 mg warfarin and Dose 5 = 5 mg warfarin
- interventionNames
- Drug: Warfarin
Primary outcomes (1)
- measure
- Determine change in AXL pathway
- timeFrame
- 30 days
- description
- Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).
Secondary outcomes (3)
- measure
- Assess adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically-confirmed, localized or metastatic adenocarcinoma of the pancreas. Diagnostic biopsy must be obtained at the study institution prior to enrollment. Pathology material must be available for review. * Patient must have measurable disease per RECIST criteria * Started most recent systemic therapy regimen within 15 days of enrollment (any line of therapy is allowed). * Ability to tolerate, swallow and absorb oral medications. * Ability to understand and the willingness to sign a written informed consent. * Age \> 18 years * Negative blood pregnancy test within seven days of study entry for WOCBP * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: * Active radiation therapy, or planned radiation therapy during study period * Subjects may not be receiving any other investigational agents. * Pregnant, nursing or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be potentially teratogenic. * Underlying condition which may increase the risk of complications from warfarin therapy. These can include: Known major bleeding diathesis: * Coagulopathy * Significant GI bleed within 6 months, * Clinically significant hematuria or hemoptysis, * Thrombolytic therapy within one month of study entry, * Active peptic ulcer disease with bleeding. - Significant infection or other coexistent medical condition that would preclude protocol therapy including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.