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Trial record 3 of 733 for:    warfarin

Biological Effect of Warfarin on Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03536208
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Warfarin Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: patients will be assigned to warfarin by mouth daily on an outpatient basis. The first 5 patients enrolled will be assigned to the 1 mg QD dose level, the next 5 patients enrolled will be assigned to the 2 mg QD dose level, and so forth until all dose levels enrolled 5 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biological Effect of Warfarin on Pancreatic Cancer
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Determine change in AXL pathway [ Time Frame: 30 days ]
    Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).


Secondary Outcome Measures :
  1. Assess adverse events [ Time Frame: 30 days ]
    Assess the adverse events (per CTCAE v4.0 criteria) associated with the addition of warfarin in patients with pancreatic cancer receiving chemotherapy.

  2. Effect of warfarin on tissue markers [ Time Frame: 30 days ]
    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.

  3. Antitumor effect [ Time Frame: 30 days ]
    Antitumor effects will be observed by change in CA9-19 levels pre and post warfarin. therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536208


Contacts
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Contact: Simmons Cancer Center CRO Office 214-648-7097 ResearchRegistry@UTSouthwestern.edu
Contact: Kimberli Crane, CCRP 214-648-7029 Kimberli.Crane@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9179
Contact: Kimberli Crane    214-648-7029    kimberli.crane@utsouthwestern.edu   
Principal Investigator: Muhammad Beg, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Muhammad S Beg, MD University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03536208     History of Changes
Other Study ID Numbers: STU 022018-090
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Warfarin
Anticoagulants