Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04134468
Recruitment Status : Withdrawn (Halozyme halted development of PEGPH20 following Phase 3 failure.)
First Posted : October 22, 2019
Last Update Posted : January 31, 2020
Halozyme Therapeutics
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: Pegvorhyaluronidase alfa Drug: Abraxane Drug: Gemcitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : February 11, 2021
Estimated Study Completion Date : November 11, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

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: Pegvorhyaluronidase alfa
IV infusion
Other Name: PEGPH20

Drug: Abraxane
IV infusion

Drug: Gemcitabine
IV infusion

Primary Outcome Measures :
  1. Change in lesion size [ Time Frame: baseline and 4 months ]
    Change in lesion size

Secondary Outcome Measures :
  1. Proportion of patients achieving a complete R0 surgical resection [ Time Frame: at time of surgery ]
    Proportion of patients achieving a complete R0 surgical resection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04134468

Layout table for location information
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
Halozyme Therapeutics
Layout table for investigator information
Principal Investigator: Thomas Karasic, MD Abramson Cancer Center at Penn Medicine
Layout table for additonal information
Responsible Party: Abramson Cancer Center at Penn Medicine Identifier: NCT04134468    
Other Study ID Numbers: UPCC10219
IRB833642 ( Other Identifier: Abramson Cancer Center )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents