BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer
Status:
Terminated
Trial end date:
2020-05-21
Target enrollment:
Participant gender:
Summary
In light of the central role of extracellular signal-regulated kinases (ERK) in pancreatic
cancer, the investigators propose a phase I study to evaluate the ERK inhibitor BVD-523 at
the recommended phase 2 dose in combination with nab-paclitaxel plus gemcitabine in patients
with newly diagnosed metastatic pancreatic cancer. The primary endpoint will be maximum
tolerated dose (MTD) or RP2D and safety. The secondary endpoints include safety, response
rate, biochemical response, progression-free survival (PFS) and overall survival (OS). The
exploratory endpoints include the assessing the impact of BVD-523 on the MEK/ERK pathway and
other major pathway pertain to pancreatic cancer.
Phase:
Phase 1
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
BioMed Valley Discoveries, Inc National Cancer Institute (NCI)