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A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Cancer

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Trial Information

A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer

1. Phase 2, multicenter open-label randomized study with a run-in phase. Run-in phase to
evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs.
Nab-paclitaxel + Gemcitabine. Phase 2 will be an open-label randomized study with same
study drugs evaluating safety and efficacy.

2. Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal
cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all
inclusion/exclusion criteria.

3. Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out
week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel +
Gemcitabine given once/week 2-4 hrs. after PEGPH20 and nab-paclitaxel + gemcitabine

4. Safety parameters include medical history, physical exams, adverse event and
Concomitant med collection, Karnofsky Performance scale, Immunogenicity, Hematology,
Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and
pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters
include standard of care CT scans, CA19-9, tumor analysis of HA.

5. Subjects continue in study until disease progression, adverse event/toxicity, death or
either the subject/sponsor discontinues the study.


Inclusion Criteria:

- Signed Informed consent

- Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented
disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue
(block /slides) available pre-dose.

- One or more measurable metastatic tumors measurable on CT san per Response Evaluation
Criteria in Solid Tumors (RECIST v.1.1 ).

- No previous radiotherapy, surgery, chemotherapy or investigational therapy for the
treatment of metastatic disease.

- Karnofsky Performance Status >= 70%

- Life expectancy >= 3 mos

- Age >= 18 years

- Screen labs of bilirubin,aspartate transaminase(AST), alanine transaminase(ALT),
serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit
and partial thromboplastin time(PTT) within specified values/criteria per protocol
prior to dosing.

Key Exclusion Criteria:

- Non metastatic pancreatic ductal adenocarcinoma

- Known Central nervous system involvement, brain metastasis

- New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction
within the past 12 months.

- Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.

- Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C

- History of another primary cancer within the last 3 years with the exception of
non-melanoma skin cancer or curatively-treated cervical cancer in-situ.

- Any other disease, metabolic dysfunction, physical examination finding or clinical
lab finding that leads to reasonable suspicion of disease or condition that
contraindicates the use of an investigational drug, that may affect interpretation of
results, or render the subject at a high risk of treatment complications.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Measured from date of randomization until disease progression or death.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Joy Zhu, MD, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Halozyme Therapeutics


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

September 2015

Related Keywords:

  • Metastatic Pancreatic Cancer
  • pancreatic ductal carcinoma(PDA)
  • Pancreatic ductal carcinoma
  • Pancreatic Neoplasms



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