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

NCT01621243 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-08-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • James Roach, MD · Momenta Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-10-24
Completion
2016-10-24

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621243 on ClinicalTrials.gov