- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536208
Biological Effect of Warfarin on Pancreatic Cancer
Study Overview
Detailed Description
There is emerging evidence from pre-clinical models that Axl activation is critical for the tumorigenesis and metastasis of pancreatic cancer. Warfarin is a readily available drug in the clinical setting and could be easily, safely, and quickly used in patients in combination with known cytotoxic chemotherapies to improve overall survival.
Oral warfarin has been well tolerated in both prophylaxis for catheter-associated thrombosis and in advanced pancreatic cancer patients.
The aim of this trial is to confirm the preclinical evidence that warfarin affects AXL pathway in patients with pancreatic cancer. This will validate the effect of escalating doses of warfarin on circulating biomarkers of AXL.
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390-9179
- University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Warfarin
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
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5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine change in AXL pathway
Time Frame: 30 days
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Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess adverse events
Time Frame: 30 days
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Assess the adverse events (per CTCAE v4.0 criteria) associated with the addition of warfarin in patients with pancreatic cancer receiving chemotherapy.
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30 days
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Effect of warfarin on tissue markers
Time Frame: 30 days
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Evaluate the effect of warfarin on tissue markers of the AXL pathways measured by western blot analysis in tumor tissue and expression levels of EMY markers following warfarin therapy.
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30 days
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Antitumor effect
Time Frame: 30 days
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Antitumor effects will be observed by change in CA9-19 levels pre and post warfarin.
therapy.
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30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad S Beg, MD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 022018-090
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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