Pancreatic Ductal AdenocarcinomaPhase 2NCT04134468
MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Pegvorhyaluronidase alfa, Abraxane and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Pegvorhyaluronidase alfa, Abraxane and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to 11 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Pegvorhyaluronidase alfa, Abraxane, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegvorhyaluronidase alfaDrug
Also called PEGPH20
IV infusion
AbraxaneDrug
IV infusion
GemcitabineDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pegvorhyaluronidase alfa; Drug: Abraxane; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion size
Change in lesion size
Measured: baseline and 4 months
Secondary outcomes (1)
Proportion of patients achieving a complete R0 surgical resection
Proportion of patients achieving a complete R0 surgical resection
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study startJan 2020 (estimated)
- Primary completion11 Feb 2021 (estimated)
- Study completion11 Nov 2022 (estimated)
Why it stopped: Halozyme halted development of PEGPH20 following Phase 3 failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Halozyme Therapeutics
- Responsible party
- Sponsor
- Investigators
- Thomas Karasic, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134468
- Sponsor's protocol ID
- UPCC10219
- Other IDs
- IRB833642
- Status last verified
- Jan 2020
- First submitted
- 18 Oct 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04134468
- Acronym / sponsor ID
- UPCC10219
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Halozyme halted development of PEGPH20 following Phase 3 failure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Halozyme Therapeutics
- Study start
- Jan 2020 (estimated)
- Primary completion
- 11 Feb 2021 (estimated)
- Study completion
- 11 Nov 2022 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine | Experimental | Drug: Pegvorhyaluronidase alfa, Drug: Abraxane, Drug: GemcitabinePegvorhyaluronidase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegvorhyaluronidase alfaAlso: PEGPH20IV infusion | Drug | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
| AbraxaneIV infusion | Drug | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
| GemcitabineIV infusion | Drug | Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine |
Primary outcome
Change in lesion size
Time frame: baseline and 4 months
Change in lesion size
1 secondary outcome
Proportion of patients achieving a complete R0 surgical resection
Time frame: at time of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Karasic, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegvorhyaluronidase alfa, Abraxane and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion size (time frame: baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.