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

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Gastrointestinal Malignancies, Pancreatic Cancer
NCT ID: NCT01621243 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-114

 

People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called 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. M402 has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether M402 administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
David P. Ryan, MD, Massachusetts General Hospital

Site-responsible Investigators:
Charles Fuchs, MD, MPH, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Between the age of 18 and 65 at screen - 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 & hepatic function - Willing to administer daily SQ injections at home Exclusion Criteria: - Prior chemotherapy for adjuvant or metastatic pancreatic cancer or treatment with gemcitabine - Brain metastasis or active second malignancy - History suspected history, or presence of Heparin Induced Toxicity (w/ or w/o thrombosis). - Documented or suspected coagulopathy/clotting disorder. - 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 d before first dose of M402 - Used NSAIDs, ASA (except ≤ 81 mg) for 10 days before screening - Past medical history of MI, cardiac ischemia, or uncompensated CAD w/in past 6 mo. - Major trauma or surgery w/in prior 6 wk
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