Back to resultsMRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegvorhyaluronidase alfa
Abraxane
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent Form
- Capable of giving informed consent.
- Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies
- Aged ≥ 18 years.
- borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.
- ECOG PS of 0 or 1
- Must have adequate organ and hematopoietic function
- Female and Males must use an approved contraceptive method
Exclusion Criteria:
- Received prior therapy for pancreatic adenocarcinoma
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Contraindication to therapeutic anticoagulation or heparin
- Intolerance to dexamethasone
- Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
- Known or suspected brain metastasis
- 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
- A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
- 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
- Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
- Subjects may not receive concomitant anticancer agents or radiation.
- Female subjects who are pregnant or nursing
- Pre-existing peripheral neuropathy > CTCAE Grade 2.
- Known allergy to hyaluronidase
- Current use of megestrol acetate (use within 10 days of Day 1)
- Inability to comply with study and follow-up procedures as judged by the Investigator
Sites / Locations
- Abramson Cancer Center at University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in lesion size
Change in lesion size
Secondary Outcome Measures
Proportion of patients achieving a complete R0 surgical resection
Proportion of patients achieving a complete R0 surgical resection
Full Information
NCT ID
NCT04134468
First Posted
October 18, 2019
Last Updated
January 30, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Halozyme Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT04134468
Brief Title
MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Halozyme halted development of PEGPH20 following Phase 3 failure.
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
February 11, 2021 (Anticipated)
Study Completion Date
November 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Halozyme Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegvorhyaluronidase alfa
Other Intervention Name(s)
PEGPH20
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Abraxane
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Change in lesion size
Description
Change in lesion size
Time Frame
baseline and 4 months
Secondary Outcome Measure Information:
Title
Proportion of patients achieving a complete R0 surgical resection
Description
Proportion of patients achieving a complete R0 surgical resection
Time Frame
at time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent Form
Capable of giving informed consent.
Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies
Aged ≥ 18 years.
borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.
ECOG PS of 0 or 1
Must have adequate organ and hematopoietic function
Female and Males must use an approved contraceptive method
Exclusion Criteria:
Received prior therapy for pancreatic adenocarcinoma
History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
Contraindication to therapeutic anticoagulation or heparin
Intolerance to dexamethasone
Contraindication to MRI or unwillingness to undergo all scheduled MRI exams
Known or suspected brain metastasis
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
A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
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
Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
Subjects may not receive concomitant anticancer agents or radiation.
Female subjects who are pregnant or nursing
Pre-existing peripheral neuropathy > CTCAE Grade 2.
Known allergy to hyaluronidase
Current use of megestrol acetate (use within 10 days of Day 1)
Inability to comply with study and follow-up procedures as judged by the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Karasic, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
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