Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization, PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).

Official Title

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

Details

  1. Phase 2, multicenter open-label randomized study with two run-in phases. The first run-in phase was to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. A second run-in phase was to evaluate a new formulation of PEGPH20.

Phase 2 will be an open-label randomized study with same study drugs evaluating safety and efficacy.

  1. 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.
  2. 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 alone
  3. Safety parameters include medical history, physical exams, adverse event and Concomitant med collection, Doppler and CT scans for thromboembolic events, prophylactic enoxaparin, 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.
  4. Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.

Keywords

Metastatic Pancreatic Cancer pancreatic ductal carcinoma(PDA) Pancreatic ductal carcinoma PEGPH20 Gemcitabine Nab-paclitaxel Pancreatic Neoplasms Paclitaxel Albumin-Bound Paclitaxel PEGPH20+nab-paclitaxel+gemcitabine nab-paclitaxel + gemcitabine

Eligibility

For people ages 18 years and up

Key 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 ), excluding the primary lesion.
  • 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 Hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, AST,ALT, serum creatinine, serum albumin, PT/INR, and PTT within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

  • Non metastatic pancreatic ductal adenocarcinoma
  • Evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) or other known thromboembolic event present during screening period.
  • Known Central nervous system involvement, brain metastasis
  • New York(NY) Heart Association Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
  • Prior history of cerebrovascular accident or transient ischemic attack
  • Pre-existing carotid artery disease
  • Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
  • Current use of megestrol acetate (Use within 10 days of Day 1)
  • 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, early state prostate cancer, or curatively-treated cervical cancer in-situ.
  • Contraindication to heparin as per NCCN guidelines
  • Previous major bleed (bleeding requiring transfusion of red blood cells) on LMWH
  • 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.

Locations

  • UCSD - Moore's Cancer Center
    La Jolla California 92093 United States
  • Scripps Cancer Center
    La Jolla California 92037 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Halozyme Therapeutics
ID
NCT01839487
Phase
Phase 2
Study Type
Interventional
Last Updated
January 11, 2018