Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma

July 3, 2023 updated by: Memorial Sloan Kettering Cancer Center

Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma

The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects. PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of hyaluronan from tumors may decrease tumor growth.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Healthcare Cancer Institute @ Hartford Hospital
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Cancer Institute
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
  • Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC.
  • Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
  • For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.
  • Karnofsky Performance Status ≥70%.
  • Life expectancy ≥3 months.
  • Age ≥18 years.
  • A negative serum pregnancy test, if female of reproductive potential.

  • Screening clinical laboratory values as follows, performed within 14 days prior to day 1:

    • Total bilirubin ≤1.5 times upper limit of normal (ULN).
    • Aspartate aminotransferase ([AST]; serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase ([ALT]; serum glutamic pyruvate transaminase [SGPT]) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
    • Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min.
    • Serum albumin ≥3.0 g/dL.
    • Absolute neutrophil count (ANC) ≥1,500 cells/mm3.
    • Platelet count ≥100,000 plt/mm3.
    • Hemoglobin ≥9 g/dL
    • Prothrombin time (PT)/international normalized ratio (INR) within normal limits (±15%) or within therapeutic range if on warfarin.
    • Partial thromboplastin time (PTT) within normal limits (±15%).
  • For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.

Exclusion Criteria:

  • Known central nervous system involvement or brain metastases.
  • New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  • Known, clinically significant carotid artery disease.
  • Known, increased risk of bleeding.
  • Patients with TE event occurring > 6months prior to enrollment and receiving active anticoagulation.
  • Patients with any prior history of arterial thrombosis or symptomatic pulmonary embolism.
  • Patients with current use of megestrol acetate (use with 10 days of Day 1) will be excluded.
  • Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
  • Known active infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
  • Known allergy to hyaluronidase.
  • Patients with prosthetic heart valves
  • Women currently pregnant or breastfeeding.
  • Intolerance of dexamethasone.
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situ.
  • History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).
  • Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
  • Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for the study.
  • Inability to comply with study and follow-up procedures as judged by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients without a prior thromboembolic event (TE)
Patients without a prior TE will be treated with prophylactic dose and schedule of rivaroxaban (10 mg QD), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.
Drug: Gemcitabine
Drug: Nab-paclitaxel
Drug: PEGPH20
Experimental: Patients with a prior thromboembolic event (TE)
Patients with a prior TE will be treated with therapeutic dose and schedule of rivaroxaban (15 mg BID for 21 days for induction if indicated, then 20 mg QD for chronic treatment), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.
Drug: Gemcitabine
Drug: Nab-paclitaxel
Drug: PEGPH20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of symptomatic TE events
Time Frame: 1 year
This includes any grade 2 or grade 3 thromboembolic event as defined by NCI CTCAE v4.0 found on incidental imaging, which would indicate a need for medical intervention.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Halozyme Therapeutics
Miami Cancer Institute

Investigators

  • Principal Investigator: Kenneth Yu, MD, MSc, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimated)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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