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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.
 
ClinicalTrials.gov 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Recruitment Status : Withdrawn (Halozyme halted development of PEGPH20 following Phase 3 failure.)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
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04134468


Locations
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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
Investigators
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Principal Investigator: Thomas Karasic, MD Abramson Cancer Center at Penn Medicine
More Information
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Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov 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

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