Clinical Trials /

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

NCT04134468

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: UPCC10219
  • SECONDARY ID: IRB833642
  • NCT ID: NCT04134468

Conditions

  • Pancreatic Ductal Adenocarcinoma

Interventions

DrugSynonymsArms
Pegvorhyaluronidase alfaPEGPH20Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
AbraxanePegvorhyaluronidase alfa plus Abraxane and Gemcitabine
GemcitabinePegvorhyaluronidase alfa plus Abraxane and Gemcitabine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pegvorhyaluronidase alfa plus Abraxane and GemcitabineExperimentalPegvorhyaluronidase 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.
  • Pegvorhyaluronidase alfa
  • Abraxane
  • Gemcitabine

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in lesion size
Time Frame:baseline and 4 months
Safety Issue:
Description:Change in lesion size

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

November 15, 2019