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

NCT02921022 | Active Not Recruiting

• 1 other identifier: 16-1066
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 10

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

Keywords

Gemcitabine; Nab-paclitaxel; PEGPH20; Rivaroxaban; thromboembolic event (TE); 16-1066

Outcome Measures

Primary Outcomes (1)

• rate of symptomatic TE events

  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

Study Arms (2)

Patients without a prior thromboembolic event (TE)

EXPERIMENTAL

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

Patients with a prior thromboembolic event (TE)

EXPERIMENTAL

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

Interventions

Gemcitabine DRUG

Patients with a prior thromboembolic event (TE); Patients without a prior thromboembolic event (TE)

Nab-paclitaxel DRUG

Patients with a prior thromboembolic event (TE); Patients without a prior thromboembolic event (TE)

PEGPH20 DRUG

Patients with a prior thromboembolic event (TE); Patients without a prior thromboembolic event (TE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Halozyme Therapeutics: collaborator
• Miami Cancer Institute: collaborator

Study Sites (10)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Miami Cancer Institute

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Thromboembolism

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; PEGPH20

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kenneth Yu, MD, MSc

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (10)