Active Clinical Trials
HALO-109-301: 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
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.
Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
- 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.
- Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.
- At least 1 tumor metastasis measurable on computed tomography (CT) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
- If a participant has had adjuvant therapy (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 adjuvant therapy, provided all toxicities have returned to baseline or ≤ Grade 1.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
- 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.
- Known central nervous system involvement or brain metastases.
- New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
- History of cerebrovascular accident or transient ischemic attack.
- Pre-existing carotid artery disease.