At a glance
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A Study of the Safety, Immunopharmacodynamics and Anti-tumor Activity of Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Ibrutinib, Paclitaxel, and 1 other intervention for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 18 participants across 2 sites.
Detailed Summary
Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be tumor promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B cells, results in increased CD8+ T cells to assist in tumor control. Preclinical studies of ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse models. Thus, the investigators propose a clinical trial of ibrutinib plus the standard gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety, then efficacy and including correlative studies.
Study Details
Timeline
Interventions
560, 840, 420, or 280mg, orally once per day - 4 week cycle
125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle