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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Warfarin||Early Phase 1|
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 :||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)|
|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|
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
5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.
- Determine change in AXL pathway [ Time Frame: 30 days ]Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).
- 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.
- 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.
- Antitumor effect [ Time Frame: 30 days ]Antitumor effects will be observed by change in CA9-19 levels pre and post warfarin. therapy.
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
|Contact: Simmons Cancer Center CRO Office||214-648-7097||ResearchRegistry@UTSouthwestern.edu|
|Contact: Kimberli Crane, CCRP||214-648-7029||Kimberli.Crane@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-9179|
|Contact: Kimberli Crane 214-648-7029 firstname.lastname@example.org|
|Principal Investigator: Muhammad Beg, MD|
|Principal Investigator:||Muhammad S Beg, MD||University of Texas Southwestern Medical Center|