A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT02399137
- Lead Sponsor
- Merrimack Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.
- Detailed Description
This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
- Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
- Blood sample sent for free IGF-1 testing
- ECOG performance status (PS) of 0 or 1
- Patients who only present with localized disease
- Patients with CNS malignancies (primary or metastatic)
- Clinically significant cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (Experimental Arm) Nab-Paclitaxel MM-141 in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Placebo Placebo in combination with nab-paclitaxel and gemcitabine Arm A (Experimental Arm) MM-141 MM-141 in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Gemcitabine Placebo in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Nab-Paclitaxel Placebo in combination with nab-paclitaxel and gemcitabine Arm A (Experimental Arm) Gemcitabine MM-141 in combination with nab-paclitaxel and gemcitabine
- Primary Outcome Measures
Name Time Method Progression Free Survival Approximately 2 years
- Secondary Outcome Measures
Name Time Method Duration of Response according to RECIST v1.1 Approximately 2 years Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm Approximately 2 years Objective Response Rate according to RECIST v1.1 Approximately 2 years Overall Survival Approximately 2.5 years
Trial Locations
- Locations (65)
Reliant Medical Group, Inc.
🇺🇸Worcester, Massachusetts, United States
Banner MD Anderson Cancer Ctr.
🇺🇸Gilbert, Arizona, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Allegheny Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Illinois Cancer Specialists
🇺🇸Chicago, Illinois, United States
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Midwest Regional Medical Cntr
🇺🇸Zion, Illinois, United States
Texas Oncology P A Bedford
🇺🇸Bedford, Texas, United States
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Caritasklinik St. Theresia
🇩🇪Saarbruecken, Saarland, Germany
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
Cancer Care Assoc Med Grp
🇺🇸Redondo Beach, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Central Coast Med Onc Corp
🇺🇸Santa Maria, California, United States
Baptist Health Med Gr Onc, LLC
🇺🇸Miami, Florida, United States
Florida Cancer AffiliatesOcala
🇺🇸Ocala, Florida, United States
Memorial Regional Hospital
🇺🇸Pembroke Pines, Florida, United States
Cancer Treatment Centers of America-Georgia
🇺🇸Newnan, Georgia, United States
Cancer Center of Acadiana Research Department
🇺🇸Lafayette, Louisiana, United States
Oncology Specialists, S.C.
🇺🇸Park Ridge, Illinois, United States
Nylen Cancer Center
🇺🇸Sioux City, Iowa, United States
Compr Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
New York Oncology HematologyPC
🇺🇸Albany, New York, United States
North Shore Hematology Oncology Associates, PC
🇺🇸East Setauket, New York, United States
Roswell Park Cancer Inst
🇺🇸Buffalo, New York, United States
Bassett Cancer Institute
🇺🇸Cooperstown, New York, United States
Columbia University
🇺🇸New York, New York, United States
Tulsa Cancer Institute, PLLC
🇺🇸Tulsa, Oklahoma, United States
Mid Ohio Onco/ Zangmeister Ctr
🇺🇸Columbus, Ohio, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Texas Oncology-Austin Midtown
🇺🇸Austin, Texas, United States
Texas Oncology-Dallas P.H.
🇺🇸Dallas, Texas, United States
Texas Oncology-Paris
🇺🇸Paris, Texas, United States
Texas Oncology-Plano East
🇺🇸Plano, Texas, United States
Brooke Army Medical Center (BAMC)
🇺🇸Fort Sam Houston, Texas, United States
Virginia Cancer Specialists PC
🇺🇸Fairfax, Virginia, United States
Texas Oncology-Tyler
🇺🇸Tyler, Texas, United States
Onc and Hem Asso of SW VA Inc
🇺🇸Salem, Virginia, United States
Cancer Care Northwest, P.S.
🇺🇸Spokane Valley, Washington, United States
Klinikum rechts der Isar - TUM
🇩🇪Munchen, Bayern, Germany
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Universitaetsklinikum Koeln
🇩🇪Koeln, Nordrhein Westfalen, Germany
Vivantes Klinikum Neukoelln
🇩🇪Berlin, Germany
Charite Universitaetsmd Berlin
🇩🇪Berlin, Germany
WSZ im. L. Rydygiera wToruniu
🇵🇱Torun, Poland
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital U de Fuenlabrada
🇪🇸Madrid, Spain
The Christie
🇬🇧Manchester, Greater Manchester, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Sarah Cannon Research Institute UK
🇬🇧London, Greater London, United Kingdom
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Northwest Cancer SpecialistsPC
🇺🇸Vancouver, Washington, United States
UCSF Cancer Center
🇺🇸San Francisco, California, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Vanderbilt-Ingram Cancer Ctr
🇺🇸Nashville, Tennessee, United States
SCRI - Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Texas Oncology SA Medical Ctr
🇺🇸San Antonio, Texas, United States
Guy's Hospital
🇬🇧London, Greater London, United Kingdom