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
Clinical Trial Information
Trial Contact: Quintiliani, Jennifer; Jarquin-Castillo, Katherine
IRB No: WIRB 20152434
Protocol Abbrev: TRIO HALO 109-301
Principal Investigator: Omar R. Kayaleh, MD
Sub Investigators: Thomas, Sajeve MD; Maddipatla, Sreeram MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: HALO
Applicable Disease Sites: Pancreas Cancer
Therapies Involved: Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Drug: Placebo, Drug: Nab-paclitaxel,Drug: Gemcitabine
ClinicalTrials.gov ID: NCT02715804
Primary Outcome Measures: • Progression-Free Survival (PFS) [ Time Frame: Approximately 12 months ]
• Overall Survival (OS) [ Time Frame: Approximately 24 months ]
Secondary Outcome Measures: • Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
• Duration of Response (DOR) [ Time Frame: Approximately 12 months ]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 12 months ]
Other Outcome Measures: • Change from Baseline in Potential Biomarkers of PEGPH20 Activity [ Time Frame: Baseline to approximately 12 months ]
• 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 ]
• Patient Reported Quality of Life [ Time Frame: Approximately 12 months ]
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.