MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma

UPCC 10219: Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer

This research study is being conducted to determine the effects of PEGPH20 plus chemotherapy treatment on the MRI characteristics of locally advanced pancreatic cancer patient tumors. Subjects will received Gemcitabine, Abraxane and PEGPH20.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Gemcitabine; Drug: Pegvorhyaluronidase alfa; Drug: Abraxane

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center at University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed Informed Consent Form
2. Capable of giving informed consent.
3. Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies
4. Aged ≥ 18 years.
5. borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.
6. ECOG PS of 0 or 1
7. Must have adequate organ and hematopoietic function
8. Female and Males must use an approved contraceptive method

Exclusion Criteria:

1. Received prior therapy for pancreatic adenocarcinoma
2. History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
3. Contraindication to therapeutic anticoagulation or heparin
4. Intolerance to dexamethasone
5. Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
6. Known or suspected brain metastasis
7. Significant cardiovascular disease such as current New York Heart Associate Class III/IV heart failure, myocardial infarction or stroke within 6 months prior to enrollment
8. A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
9. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint
10. Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
11. Subjects may not receive concomitant anticancer agents or radiation.
12. Female subjects who are pregnant or nursing
13. Pre-existing peripheral neuropathy > CTCAE Grade 2.
14. Known allergy to hyaluronidase
15. Current use of megestrol acetate (use within 10 days of Day 1)
16. Inability to comply with study and follow-up procedures as judged by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine; Pegvorhyaluronidase alfa 3ug/kg IV twice weekly during Cycle 1 and then weekly on days of chemotherapy during Cycles 2-4. Abraxane 125mg/m2 IV and Gemcitabine 1000mg/m2 IV on Day 1, 8, 15 of Cycles 1-4. All cycles will be 28 days.	Drug: Gemcitabine; IV infusion; Drug: Pegvorhyaluronidase alfa; IV infusion; Other Names: PEGPH20; Drug: Abraxane; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lesion size	Change in lesion size	baseline and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving a complete R0 surgical resection	Proportion of patients achieving a complete R0 surgical resection	at time of surgery

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: Halozyme Therapeutics
• Investigators: Principal Investigator: Thomas Karasic, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): February 11, 2021
• Study Completion (Anticipated): November 11, 2022

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Albumin-Bound Paclitaxel
• Other Study ID Numbers: UPCC10219; IRB833642 (Other Identifier: Abramson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No