NCT01621243

M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Momenta Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle
DRUG	gemcitabine	gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle
DRUG	placebo	Placebo will be dosed daily
DRUG	Necuparanib	Necuparanib will be dosed daily

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-10-24
• Completion: 2016-10-24
• First posted: 2012-06-18
• Last updated: 2018-08-29

Locations

37 sites across 2 countries: United States, Canada