NCT02608229

BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer

Phase Ib Study of BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Cancer of Pancreas
• Cancer of the Pancreas
• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	BVD-523
DRUG	Nab-paclitaxel
DRUG	Gemcitabine
PROCEDURE	Tumor biopsy

Timeline

• Start date: 2016-06-06
• Primary completion: 2019-03-27
• Completion: 2020-05-21
• First posted: 2015-11-18
• Last updated: 2021-04-21
• Results posted: 2020-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study