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A Study of PEGylated Recombinant Human Hyaluronidase 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

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ClinicalTrials.gov Identifier: NCT02715804
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Stage IV Pancreatic Ductal Adenocarcinoma Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) Drug: Placebo Drug: Nab-paclitaxel Drug: Gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: 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
Study Start Date : February 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEGPH20 + nab-paclitaxel + gemcitabine Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
PEGPH20 will be administered at a dose of 3.0 micrograms per kilograms (μg/kg) as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond.

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered as an IV infusion at 125 milligrams per square meter (mg/m2), once weekly for Weeks 1 to 3 of all treatment cycles.

Drug: Gemcitabine
Gemcitabine will be administered as an IV infusion at 1000 mg/m2, once weekly for Weeks 1 to 3 of all treatment cycles.

Active Comparator: Placebo + nab-paclitaxel + gemcitabine Drug: Placebo
Matching placebo for PEGPH20

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered as an IV infusion at 125 milligrams per square meter (mg/m2), once weekly for Weeks 1 to 3 of all treatment cycles.

Drug: Gemcitabine
Gemcitabine will be administered as an IV infusion at 1000 mg/m2, once weekly for Weeks 1 to 3 of all treatment cycles.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Approximately 12 months ]
  2. Overall Survival (OS) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
  2. Duration of Response (DOR) [ Time Frame: Approximately 12 months ]
  3. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 12 months ]

Other Outcome Measures:
  1. Change from Baseline in Potential Biomarkers of PEGPH20 Activity [ Time Frame: Baseline to approximately 12 months ]
  2. Peak Plasma Concentration (Cmax) of PEGPH20 in combination with nab-paclitaxel plus gemcitabine [ Time Frame: Concentration at 24 hours postdose on Day 1, Day 2, and Day 4 of Cycle 1 for PEGPH20 treatment; concentrations after the end of infusion on Day 2 of Cycle 1 through Cycle 3 for nab-paclitaxel plus gemcitabine treatment ]
  3. Patient Reported Quality of Life [ Time Frame: Approximately 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic site.
  3. Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.
  4. At least 1 tumor metastasis measurable on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
  5. If a participant 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.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion criteria:

  1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
  2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

    a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.

  3. Known central nervous system involvement or brain metastases.
  4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  5. History of cerebrovascular accident or transient ischemic attack.
  6. Clinically significant pre-existing carotid artery disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715804


Contacts
Contact: Halozyme Study Information 1 844 855 HALO (4256) MedInfo@halozyme.com

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Sponsors and Collaborators
Halozyme Therapeutics

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT02715804     History of Changes
Other Study ID Numbers: HALO-109-301
2015-004068-13 ( EudraCT Number )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by Halozyme Therapeutics:
Pancreatic ductal adenocarcinoma (PDA)
Pancreatic ductal carcinoma
PEGylated Recombinant Human Hyaluronidase (PEGPH20)
Nab-paclitaxel
Gemcitabine
Metastatic
Stage IV

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Hyaluronic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Viscosupplements
Protective Agents