Biological Effect of Warfarin on Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Biological Effect of Warfarin on Pancreatic Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03536208
• Other study ID #: STU 022018-090
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: May 15, 2019
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Warfarin
5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine change in AXL pathway	Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).	30 days
Secondary	Assess adverse events	Assess the adverse events (per CTCAE v4.0 criteria) associated with the addition of warfarin in patients with pancreatic cancer receiving chemotherapy.	30 days
Secondary	Effect of warfarin on tissue markers	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.	30 days
Secondary	Antitumor effect	Antitumor effects will be observed by change in CA9-19 levels pre and post warfarin. therapy.	30 days