Biological Effect of Warfarin on Pancreatic Cancer

NCT ID: NCT03536208

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2022-06-30

Brief Summary

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

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.

Interventions

Warfarin

5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Beg

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad S Beg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 022018-090

Identifier Type: -

Identifier Source: org_study_id