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

Abramson Cancer Center at Penn Medicine

Status and phase: Withdrawn; Phase 2

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Drug: Gemcitabine; Drug: Pegvorhyaluronidase alfa; Drug: Abraxane

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04134468

IRB833642 (Other Identifier)

UPCC10219

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine

Experimental group

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.

Treatment:

Drug: Gemcitabine

Drug: Pegvorhyaluronidase alfa

Drug: Abraxane