Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Terminated

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

NCT01621243↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlyThe study was terminated after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation. (Efficacy or futility)
Phase
Phase 1 / Phase 2
Status
Terminated
Study type
Interventional
Start
May 2012
Expected end
24 October 2016
Enrollment
128 participants
Sites
37
Primary outcomes
Part A: Safety; Part B: Overall Survival
Sponsor
Industry
Results posted
No
Last update
29 August 2018

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Papers 2