Pancreatic CancerEarly Phase 1NCT03536208
Biological Effect of Warfarin on Pancreatic Cancer
A Early Phase 1 study testing Warfarin in people with Pancreatic Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9179
About this study
This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma.
Read the 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
- Being tested
- Warfarin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine change in AXL pathway
Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 30 days
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.
Measured: 30 days
Antitumor effect
Antitumor effects will be observed by change in CA9-19 levels pre and post warfarin. therapy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start15 May 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: no accrual for over 12 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Beg, University of Texas Southwestern Medical Center
- Investigators
- Muhammad S Beg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536208
- Sponsor's protocol ID
- STU 022018-090
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2018
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Effect of Warfarin on Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03536208
- Acronym / sponsor ID
- STU 022018-090
- Conditions
- Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no accrual for over 12 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Experimental | Drug: WarfarinPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg. | Drug | Warfarin |
Primary outcome
Determine change in AXL pathway
Time frame: 30 days
Determine change in circulating biomarkers of AXL pathways (including phosphogas6, soluble AXL).
3 secondary outcomes
Assess adverse events
Time frame: 30 days
Effect of warfarin on tissue markers
Time frame: 30 days
Antitumor effect
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad S Beg, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Warfarin in people with Pancreatic Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine change in AXL pathway (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.