NCT04134468

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

October 18, 2019

Last Update Submit

January 30, 2020

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Change in lesion size

    Change in lesion size

    baseline and 4 months

Secondary Outcomes (1)

  • Proportion of patients achieving a complete R0 surgical resection

    at time of surgery

Study Arms (1)

Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine

EXPERIMENTAL

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 alfaDrug: AbraxaneDrug: Gemcitabine

Interventions

Pegvorhyaluronidase alfaDRUG

IV infusion

Also known as: PEGPH20
Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
AbraxaneDRUG

IV infusion

Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine
GemcitabineDRUG

IV infusion

Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

PEGPH20Albumin-Bound PaclitaxelGemcitabine

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Thomas Karasic, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

January 1, 2020

Primary Completion

February 11, 2021

Study Completion

November 11, 2022

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)