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Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer

Clinical Trial Summary

To identify the maximally tolerated dose of ficlatuzumab when combined with nab-paclitaxel and gemcitabine in patients with previously untreated pancreatic cancer.

Clinical Trial Description

This research study is a Phase I dose-escalation clinical trial. It will test the safety and tolerability of an investigational drug ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine, with the goal of determining the maximally tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Ficlatuzumab is a type of drug called a "monoclonal antibody." It is thought to work by targeting hepatocyte growth factor (HGF) which is a HGF-c-Met inhibitor. The activation of the receptor tyroside kinase c-Met via its ligand, HGF, mediates proliferation, motility, and differentiation in a variety of cancers including pancreatic cancer. Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer and meet all inclusion/exclusion criteria. Treatment consists of 4 week treatment cycles. Ficlatuzumab will be administered on day 1 and 15 of each cycle. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15. Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject or sponsor discontinues the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03316599
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 1
Start date January 17, 2018
Completion date July 29, 2021
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