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

Pancreatic Ductal Adenocarcinoma Clinical Trial

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04134468
• Other study ID #: UPCC10219
• Secondary ID: IRB833642
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: November 11, 2022

Study information

• Verified date: January 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 11, 2022
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• Pegvorhyaluronidase alfa
IV infusion
• Abraxane
IV infusion
• Gemcitabine
IV infusion

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	Halozyme Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lesion size	Change in lesion size	baseline and 4 months
Secondary	Proportion of patients achieving a complete R0 surgical resection	Proportion of patients achieving a complete R0 surgical resection	at time of surgery