Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Andrew Ko

Description

Summary

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Keywords

Stage IV Pancreatic Ductal Adenocarcinoma Pancreatic ductal adenocarcinoma (PDA) Pancreatic ductal carcinoma PEGylated Recombinant Human Hyaluronidase (PEGPH20) Nab-paclitaxel Gemcitabine Metastatic Stage IV Adenocarcinoma Paclitaxel Albumin-Bound Paclitaxel Hyaluronic Acid Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) PEGPH20 + nab-paclitaxel + gemcitabine

Eligibility

You can join if…

Open to people ages 18 years and up

Subjects must satisfy all the following inclusion criteria to be enrolled in the study:

  1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form(s).
  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological or cytological confirmation of PDA.
  3. Subjects must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the subject has documented metastatic disease.

Biopsies/samples must meet the following requirements:

  1. Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable.
  2. Tumor biopsies or samples must meet the requirements provided in the Study

Laboratory Manual with regard to tumor tissue architecture. Note: cytology samples from fine needle aspirates without maintained tissue architecture or brushing biopsies are not acceptable.

  1. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides(10 slides are preferred) of 1 archival block that meet specific tissue sample requirements (see Study Laboratory Manual).
  2. Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
  3. If a subject has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or ≤ Grade 1.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  5. Life expectancy ≥3 months.
  6. Age ≥18 years.
  7. A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1;first dose of study medication) if female subject is of childbearing potential.
  8. . Screening clinical laboratory values as follows:
  9. Total bilirubin ≤1.5 times upper limit of normal (ULN) (subjects with Gilbert syndrome are eligible independent of bilirubin levels).
  10. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
  11. Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 mL/min.
  12. Serum albumin ≥2.5 g/dL.
  13. Prothrombin time or international normalized ratio (INR) within normal limits(±15%), unless subject takes warfarin, in which case prothrombin time or INR result must be within therapeutic range.
  14. Partial thromboplastin time (PTT) within normal limits (±15%).
  15. Hemoglobin ≥9 g/dL (transfusion and erythropoietic agents allowed).
  16. Absolute neutrophil count ≥1,500 cells/mm3.
  17. Platelet count ≥100,000/mm3.
  18. . For women of childbearing potential (WOCBP) and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 1 month (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization,intrauterine device (IUD), intrauterine hormone-releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.

You CAN'T join if...

Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:

  1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known TE event present during the screening period.
  2. Subjects with superficial vein thrombosis are eligible.
  3. Subjects with visceral/splanchnic vein thrombosis are still eligible if, in the opinion of the Investigator, the visceral/splanchnic vein thrombosis is primarily associated with the anatomic location of the underlying disease of metastatic pancreatic cancer.
  4. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
  5. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
  6. Known central nervous system involvement or brain metastases.
  7. New York Heart Association Class III or IV cardiac disease (Appendix C) or myocardial infarction within the past 12 months.
  8. History of cerebrovascular accident or transient ischemic attack.
  9. Clinically significant pre-existing carotid artery disease.
  10. Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months.
  11. Known allergy to hyaluronidase.
  12. Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1).
  13. . Contraindication to heparin as per institutional guidelines.
  14. . Women currently pregnant or breastfeeding.
  15. . Intolerance to dexamethasone.
  16. . History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
  17. . Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, 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, or that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
  18. . Immunization with a live vaccine up to 2 weeks prior to Day 1.
  19. . Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel.
  20. . Inability to comply with study and follow-up procedures as judged by the Investigator.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • Pacific Hematology Oncology Associates accepting new patients
    San Francisco California 94115 United States
  • St Joseph Heritage Healthcare accepting new patients
    Santa Rosa California 95405 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Halozyme Therapeutics
ID
NCT02715804
Phase
Phase 3
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
September 5, 2018