Pancreatic CancerNCT02921022
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
A study testing Gemcitabine, Nab-paclitaxel and PEGPH20 in people with Pancreatic Cancer and Advanced Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial summary
The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Advanced Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Gemcitabine, Nab-paclitaxel and PEGPH20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2016to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC.
- Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.
- Karnofsky Performance Status ≥70%.
- Life expectancy ≥3 months.
Show all 19Show fewer
- Age ≥18 years.
- A negative serum pregnancy test, if female of reproductive potential.
- Screening clinical laboratory values as follows, performed within 14 days prior to day 1:
- Total bilirubin ≤1.5 times upper limit of normal (ULN).
- Aspartate aminotransferase ([AST]; serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase ([ALT]; serum glutamic pyruvate transaminase [SGPT]) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
- Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min.
- Serum albumin ≥3.0 g/dL.
- Absolute neutrophil count (ANC) ≥1,500 cells/mm3.
- Platelet count ≥100,000 plt/mm3.
- Hemoglobin ≥9 g/dL
- Prothrombin time (PT)/international normalized ratio (INR) within normal limits (±15%) or within therapeutic range if on warfarin.
- Partial thromboplastin time (PTT) within normal limits (±15%).
- For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.
Who cannot join
- Known central nervous system involvement or brain metastases.
- New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- Known, clinically significant carotid artery disease.
- Known, increased risk of bleeding.
- Patients with TE event occurring > 6months prior to enrollment and receiving active anticoagulation.
- Patients with any prior history of arterial thrombosis or symptomatic pulmonary embolism.
Show all 18Show fewer
- Patients with current use of megestrol acetate (use with 10 days of Day 1) will be excluded.
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
- Known active infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
- Known allergy to hyaluronidase.
- Patients with prosthetic heart valves
- Women currently pregnant or breastfeeding.
- Intolerance of dexamethasone.
- History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situ.
- History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).
- Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
- Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for the study.
- Inability to comply with study and follow-up procedures as judged by the Investigator.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Miami Cancer Institute
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects. PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of hyaluronan from tumors may decrease tumor growth.
- Being tested
- Gemcitabine, Nab-paclitaxel, PEGPH20
- Keywords
- Gemcitabine, Nab-paclitaxel, PEGPH20, Rivaroxaban, thromboembolic event (TE), 16-1066
- Medical subject headings
- Pancreatic Neoplasms, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Nab-paclitaxelDrug
PEGPH20Drug
| Study group | Role | What they receive |
|---|---|---|
| Patients without a prior thromboembolic event (TE) | Experimental | Patients without a prior TE will be treated with prophylactic dose and schedule of rivaroxaban (10 mg QD), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: PEGPH20 |
| Patients with a prior thromboembolic event (TE) | Experimental | Patients with a prior TE will be treated with therapeutic dose and schedule of rivaroxaban (15 mg BID for 21 days for induction if indicated, then 20 mg QD for chronic treatment), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: PEGPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of symptomatic TE events
This includes any grade 2 or grade 3 thromboembolic event as defined by NCI CTCAE v4.0 found on incidental imaging, which would indicate a need for medical intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Halozyme Therapeutics, Miami Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Kenneth Yu, MD, MSc, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921022
- Sponsor's protocol ID
- 16-1066
- Status last verified
- Nov 2026
- First submitted
- 29 Sep 2016
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02921022
- Acronym / sponsor ID
- 16-1066
- Keywords
- Gemcitabine, Nab-paclitaxel, PEGPH20, Rivaroxaban, thromboembolic event (TE), 16-1066
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Halozyme Therapeutics, Miami Cancer Institute
- Study start
- Oct 2016
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- 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.
The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects. PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of hyaluronan from tumors may decrease tumor growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without a prior thromboembolic event (TE) | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: PEGPH20Patients without a prior TE will be treated with prophylactic dose and schedule of rivaroxaban (10 mg QD), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20. |
| Patients with a prior thromboembolic event (TE) | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: PEGPH20Patients with a prior TE will be treated with therapeutic dose and schedule of rivaroxaban (15 mg BID for 21 days for induction if indicated, then 20 mg QD for chronic treatment), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC.
- Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.
- Karnofsky Performance Status ≥70%.
Key exclusion criteria (18 listed)
- Known central nervous system involvement or brain metastases.
- New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- Known, clinically significant carotid artery disease.
- Known, increased risk of bleeding.
- Patients with TE event occurring > 6months prior to enrollment and receiving active anticoagulation.
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 |
|---|---|---|
| Gemcitabine | Drug | Patients with a prior thromboembolic event (TE), Patients without a prior thromboembolic event (TE) |
| Nab-paclitaxel | Drug | Patients with a prior thromboembolic event (TE), Patients without a prior thromboembolic event (TE) |
| PEGPH20 | Drug | Patients with a prior thromboembolic event (TE), Patients without a prior thromboembolic event (TE) |
Primary outcome
rate of symptomatic TE events
Time frame: 1 year
This includes any grade 2 or grade 3 thromboembolic event as defined by NCI CTCAE v4.0 found on incidental imaging, which would indicate a need for medical intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Kenneth Yu, MD, MSc principal investigator
Memorial Sloan Kettering Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine, Nab-paclitaxel and PEGPH20 in people with Pancreatic Cancer and Advanced Pancreatic Ductal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 10 sites 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 19 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
rate of symptomatic TE events (time frame: 1 year). 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 4 Nov 2026.