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 Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Phase 1

Active, not recruiting

• Conditions: Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004068-13-HU
• Lead Sponsor: Halozyme, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-18
• Study Completion: 2019-11-04
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 492

Inclusion Criteria

1. Signed, written Institutional Review Board/Ethics Committee
approved Informed Consent Form (ICF).
2. Stage IV 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:
a. 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.
b. 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.
c. 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). Radiographic confirmation.
4. Radiographic confirmation of Stage IV PDA with at least 1 tumor
metastasis measurable on CT scan or MRI per RECIST version 1.1
criteria, excluding the primary pancreatic lesion.
5.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.
6. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 253
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 247

Exclusion Criteria

1. Clinical evidence of DVT, PE or other known 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified