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Pancreas CancerPhase 1PAP-UPNCT04191928

Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy

A Phase 1 study testing Apixaban in people with Pancreas Cancer and DVT, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study investigators will examine the absorption characteristics of apixaban, a direct-acting oral anticoagulation, in patients who have underwent a particular kind of surgery (pancreaticoduodenectomy) which involves resection of the duodenum. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pancreas Cancer, DVT, Pulmonary Embolism
What is being tested?
Apixaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
3 Mar 2020to 1 Sep 2021
Phase
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a male or female between ages 18-65 (inclusive) at the screening visit
  • May have a history of pharmacologically well-controlled hypertension or non-insulin dependent diabetes
  • Have a body mass index (BMI) ≥ 19 and ≤ 33 (inclusive)
  • BMI = (weight (kg))/(height (m2))
  • Have a history of pancreaticoduodenectomy
  • If female, subject can be of childbearing potential and must demonstrate a urine β-hCG level consistent with the non-gravid state at the screening visit and agree to use (and/or have their partner use) an acceptable method of birth control beginning at the screening visit throughout the trial (including washout intervals between treatment periods) and until 2 weeks after the last dose of trial drug in the last treatment period. Acceptable methods of birth control: intrauterine device ("IUD" with or without local hormone release, oral contraceptive pills, diaphragm, cervical cap, spermicides, contraceptive sponge, and /or condoms). Abstinence is an alternative life style and subjects practicing abstinence may be included in the trial.
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  • Can be of non-childbearing potential which is defined as: a female who is postmenopausal without menses for at least 1 year and an FSH value in the postmenopausal range upon screening evaluation and/or a female who is status post hysterectomy, oophorectomy or tubal ligation.
  • Have serum creatinine level < 1.5 mg/dL
  • Have a prothrombin time (PT) and activated partial thromboplastin time (PTT) level below the upper limit of normal
  • Have platelet count within normal limits
  • Be willing to refrain from the use of anticoagulants and antiplatelet medications including aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) during the entire period of study participation
  • Be willing to comply with trial restrictions

Who cannot join

  • The subject will be excluded from participating in the trial if the subject:
  • Has a history of clinically significant medical condition that based upon the judgment of the investigator makes participation inappropriate
  • Has a history of a major bleeding event (defined as: (i) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or (ii) a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells) within 6 months prior to screening visit
  • Has had major surgery within 6 months prior to screening visit
  • Is actively taking any the following list of medications/supplements and cannot hold these medications for <5 half-lives prior to the study:
  • CYP3A4 Moderate/Strong Inhibitors:
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  • Selective Serotonin Reuptake Inhibitors (SSRI) Amiodarone, Dronedarone Diltiazem Cimetidine Aprepitant Protease Inhibitors CYP3A4 Inducers Rifampin Phenytoin Carbemazepine Ritonavir St. John's Wort Enzalutamide Efavirenz Teriflunomide Bosentan Modafinil Mitotane Other Pancreatic Enzyme Replacement (Creon, Pancrelipase, Viokase)
  • Has a history of illicit drug abuse within six months prior to screening visit
  • Is an active smoker (last exposure <2 weeks prior to study screening)
  • Pregnant or lactating
  • Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day and cannot refrain from alcohol for the duration of the trial
  • Has a history of significant multiple and/or severe allergies (e.g. food, drug), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Has known anaphylactic or severe systemic reactions to any components of apixaban or contraindication to the administration of apixaban
  • Has moderate or severe hepatic disease or other clinically relevant bleeding risk
  • Use of any drugs or products which at the discretion of the investigator would increase bleeding risk
  • Is considered inappropriate for participation by the investigator for any reason

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University Clinical Research Unit

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: An Exploratory Study of the Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy

Study investigators will examine the absorption characteristics of apixaban, a direct-acting oral anticoagulation, in patients who have underwent a particular kind of surgery (pancreaticoduodenectomy) which involves resection of the duodenum.

Read the detailed description

This study will examine apixaban pharmacokinetic exposure (AUC(0-24)) and maximum concentration (Cmax) when administered as a single oral dose in patients who have undergone pancreaticoduodenectomy (PD) compared to historical controls. This is a phase one, single dose pharmacokinetic study in stable patients who have undergone pancreaticoduodenectomy. Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This study aims to compare the pharmacokinetics and absorption of oral apixaban in patients who have undergone pancreaticoduodenectomy to that of apixaban in historical controls.

Being tested
Apixaban
Keywords
apixaban, pancreaticoduodenectomy, whipple, pharmacokinetic
Medical subject headings
Pancreatic Neoplasms, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called Eliquis

    Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Study groups in NCT04191928
Study groupRoleWhat they receive
Apixaban dosingExperimentalSubjects to receive single dose of apixaban
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Apixaban Level

    Serum apixaban PK level

    Measured: 0-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start3 Mar 2020
  3. Primary completion25 Jul 2020
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-dose pharmacokinetic study
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04191928
Sponsor's protocol ID
19D.811
Acronym
PAP-UP
Status last verified
Dec 2021
First submitted
6 Dec 2019
Last updated
23 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apixaban in people with Pancreas Cancer and DVT, run by Thomas Jefferson University 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 12 inclusion and 16 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: finished, as of the sponsor's last update on 23 Dec 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Serum Apixaban Level (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04191928.

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 23 Dec 2021.

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