Biological Effect of Warfarin on Pancreatic Cancer

NCT03536208 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: STU 022018-090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Determine change in AXL pathway

  Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).

  30 days

Secondary Outcomes (3)

• Assess adverse events

  30 days

• Effect of warfarin on tissue markers

  30 days

• Antitumor effect

  30 days

Study Arms (1)

Warfarin

EXPERIMENTAL

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

Interventions

Warfarin DRUG

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

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Active radiation therapy, or planned radiation therapy during study period
• Subjects may not be receiving any other investigational agents.
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9179, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Muhammad S Beg, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 24, 2018
• Study Start: May 15, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

US (1)