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

NCT ID: NCT02921022

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Pancreatic Cancer; Advanced Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Nab-paclitaxel

Intervention Type: DRUG

PEGPH20

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Nab-paclitaxel

Intervention Type: DRUG

PEGPH20

Intervention Type: DRUG

Interventions

Gemcitabine

Intervention Type: DRUG

Nab-paclitaxel

Intervention Type: DRUG

PEGPH20

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Halozyme Therapeutics

INDUSTRY

Sponsor Role: collaborator

Miami Cancer Institute

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Yu, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Miami Cancer Institute

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Countries

United States

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

16-1066

Identifier Type: -

Identifier Source: org_study_id