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

• Status: Terminated
• Trial end date: 2016-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Momenta Pharmaceuticals, Inc.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Age of 18 years or older

• Confirmed pancreatic ductal adenocarcinoma

• Metastatic disease as documented by CT scan or MRI (locally advanced disease only NOT eligible)

• At least 1 site of disease measurable by RECIST ver1.1

• ECOG performance status of 0 to 1

• Adequate bone marrow, renal capacity and hepatic function

• Willing to administer daily subcutaneous injections at home

Exclusion Criteria:

• Any prior radiotherapy, chemotherapy, surgery, or investigational therapy for adjuvant or metastatic pancreatic cancer

• History of suspected history, or presence of heparin induced toxicity (w/ or w/o thrombosis)

• History of unexplained bleeding episodes within 3 months of M402 dosing

• Received thrombolytic agents w/in the previous month

• Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in 90 days before first dose of M402

• High cardiovascular risk, including but not limited to, recent coronary stenting or myocardial infarction in the past year

• Major trauma or surgery w/in prior 4 weeks