M402 in Combination With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
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.
Massachusetts General Hospital, Dana-Farber Cancer Institute
David P. Ryan, MD,
Massachusetts General Hospital
Charles Fuchs, MD, MPH,
Dana-Farber Cancer Institute
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960
- 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
- 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
- Prior chemotherapy for adjuvant or metastatic pancreatic cancer or treatment with
- Brain metastasis or active second malignancy
- History suspected history, or presence of Heparin Induced Toxicity (w/ or w/o
- 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