Metastatic Pancreatic Cancer Clinical Trial
Official title:
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
Verified date | January 2017 |
Source | Momenta Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 128 |
Est. completion date | October 24, 2016 |
Est. primary completion date | October 24, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHUM Hospital St-Luc | Montreal | Quebec |
Canada | The Ottawa Hospital Cancer Center | Ottawa | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Illinois Cancer Specialists | Arlington Heights | Illinois |
United States | University of Colorado School of Medicine - Division of Medical Oncology | Aurora | Colorado |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Montefiore-Einstein Center for Cancer Care | Bronx | New York |
United States | Ohio State University | Columbus | Ohio |
United States | Karmanos Cancer Center | Detroit | Michigan |
United States | Poudre Valley Health System | Fort Collins | Colorado |
United States | Cancer Center of the Carolinas/ITOR | Greenville | South Carolina |
United States | Penn State Hershey Cancer Center | Hershey | Pennsylvania |
United States | Clearview Cancer Institute | Huntsville | Alabama |
United States | University of Kansas Cancer Center | Kansas City | Missouri |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Crescent City Research Consortium | Marrero | Louisiana |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Hartford Healthcare Cancer Institute at Midstate Medical Center | Meriden | Connecticut |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Southeastern Regional Medical Center | Newnan | Georgia |
United States | Northwest Cancer Specialists | Portland | Oregon |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Metro-Minnesota Community Clinical Oncology Program | Saint Louis Park | Minnesota |
United States | University of Texas Health Sciences Center | San Antonio | Texas |
United States | Florida Hospital Tampa | Tampa | Florida |
United States | University of Maryland- St Joseph's Medical Center | Towson | Maryland |
United States | Arizona Clinical Research Center | Tucson | Arizona |
United States | University of Arizona | Tucson | Arizona |
United States | Texas Oncology | Tyler | Texas |
United States | Texas Oncology, P.A. | Tyler | Texas |
United States | Umass Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Momenta Pharmaceuticals, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Safety | At baseline and then each of 6 visits after the start of dosing in a 28-day treatment cycle, adverse event surveillance, liver function enzyme levels, WBC with differential, ANC, aPTT, and PT are measured. This is repeated for each 28 day treatment cycle until disease progression or end of treatment. A final assessment is performed 30 days post-final necuparanib dose. | Part A: Baseline to 28 days after first-dose and end of study | |
Primary | Part B: Overall Survival | Time in months from first dose of study medication until death | Time in months from first dose of study medication until death | |
Secondary | Part A: Maximum concentration of necuparanib | One before and seven blood samples after the first dose followed by 5 additional lab draws, once at each of the 5 remaining visits in the first 28-day cycle. | Baseline to 28 days after first dose. | |
Secondary | Part B: Duration of progression-free survival | Time in months from first dose of study drug until disease progression | Time from first dose of study drug until disease progression |
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