Metastatic Pancreatic Cancer Clinical Trial
Official title:
A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer
People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.
Part A was an open-label, multiple ascending dose patient study of necuparanib given first as
a single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen.
It was conducted to evaluate the safety and tolerability of necuparanib alone and in
combination with nab-paclitaxel and gemcitabine and to recommend a necuparanib dose regimen
for subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating
the antitumor activity of necuparanib in combination with nab-paclitaxel and gemcitabine
compared with nab-paclitaxel, gemcitabine, and placebo. In both Parts A and B, a treatment
period consists of one 28-day cycle. The Study Patient and Investigator can decide to
continue with additional 28-day cycles according to the patient's status at the end of each
28-day cycle. Part A has completed enrollment and Part B is currently open.
Part A - Primary Objectives:
- To evaluate the safety and tolerability of necuparanib in combination with
nab-paclitaxel and gemcitabine.
- To determine the dose of necuparanib to be carried forward into Part B.
Part B - Primary Objective:
To evaluate overall survival in patients treated with necuparanib + nab-paclitaxel +
gemcitabine compared with placebo + nab-paclitaxel + gemcitabine.
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