Pancreatic Cancer Clinical Trial
— CARRIEOfficial title:
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
| Verified date | September 2018 |
| Source | Merrimack Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | August 2018 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients who only present with localized disease - Patients with CNS malignancies (primary or metastatic) - Clinically significant cardiac disease |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Germany | Charite Universitaetsmd Berlin | Berlin | |
| Germany | Vivantes Klinikum Neukoelln | Berlin | |
| Germany | Universitaetsklinikum Koeln | Koeln | Nordrhein Westfalen |
| Germany | Klinikum rechts der Isar - TUM | Munchen | Bayern |
| Germany | Caritasklinik St. Theresia | Saarbruecken | Saarland |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | |
| Poland | WSZ im. L. Rydygiera wToruniu | Torun | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Centro Integral Oncologico Clara Campal | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital U de Fuenlabrada | Madrid | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| United Kingdom | Guy's Hospital | London | Greater London |
| United Kingdom | Sarah Cannon Research Institute UK | London | Greater London |
| United Kingdom | The Christie | Manchester | Greater Manchester |
| United Kingdom | Royal Marsden Hospital | Sutton | Surrey |
| United Kingdom | Royal Marsden Hospital | Sutton | |
| United States | New York Oncology HematologyPC | Albany | New York |
| United States | Pacific Cancer Medical Center, Inc. | Anaheim | California |
| United States | Rocky Mountain Cancer Centers | Aurora | Colorado |
| United States | Texas Oncology-Austin Midtown | Austin | Texas |
| United States | Texas Oncology P A Bedford | Bedford | Texas |
| United States | St. Luke's University Health Network | Bethlehem | Pennsylvania |
| United States | Roswell Park Cancer Inst | Buffalo | New York |
| United States | Illinois Cancer Specialists | Chicago | Illinois |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | Mid Ohio Onco/ Zangmeister Ctr | Columbus | Ohio |
| United States | Bassett Cancer Institute | Cooperstown | New York |
| United States | Texas Oncology-Dallas P.H. | Dallas | Texas |
| United States | North Shore Hematology Oncology Associates, PC | East Setauket | New York |
| United States | Virginia Cancer Specialists PC | Fairfax | Virginia |
| United States | Brooke Army Medical Center (BAMC) | Fort Sam Houston | Texas |
| United States | St. Jude Heritage Healthcare | Fullerton | California |
| United States | Banner MD Anderson Cancer Ctr. | Gilbert | Arizona |
| United States | Compr Cancer Centers of Nevada | Henderson | Nevada |
| United States | Cancer Center of Acadiana Research Department | Lafayette | Louisiana |
| United States | UCLA School of Medicine | Los Angeles | California |
| United States | Baptist Health Med Gr Onc, LLC | Miami | Florida |
| United States | SCRI - Tennessee Oncology | Nashville | Tennessee |
| United States | Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee |
| United States | Columbia University | New York | New York |
| United States | Columbia University Medical Center | New York | New York |
| United States | Cancer Treatment Centers of America-Georgia | Newnan | Georgia |
| United States | Florida Cancer AffiliatesOcala | Ocala | Florida |
| United States | Texas Oncology-Paris | Paris | Texas |
| United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
| United States | Memorial Regional Hospital | Pembroke Pines | Florida |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Allegheny Cancer Center | Pittsburgh | Pennsylvania |
| United States | Texas Oncology-Plano East | Plano | Texas |
| United States | Cancer Care Assoc Med Grp | Redondo Beach | California |
| United States | Onc and Hem Asso of SW VA Inc | Salem | Virginia |
| United States | Texas Oncology SA Medical Ctr | San Antonio | Texas |
| United States | UCSF Cancer Center | San Francisco | California |
| United States | Sansum Clinic | Santa Barbara | California |
| United States | Central Coast Med Onc Corp | Santa Maria | California |
| United States | Nylen Cancer Center | Sioux City | Iowa |
| United States | Cancer Care Northwest, P.S. | Spokane Valley | Washington |
| United States | Tulsa Cancer Institute, PLLC | Tulsa | Oklahoma |
| United States | Texas Oncology-Tyler | Tyler | Texas |
| United States | Northwest Cancer SpecialistsPC | Vancouver | Washington |
| United States | Reliant Medical Group, Inc. | Worcester | Massachusetts |
| United States | Midwest Regional Medical Cntr | Zion | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Merrimack Pharmaceuticals |
United States, Canada, Germany, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | Approximately 2 years | ||
| Secondary | Overall Survival | Approximately 2.5 years | ||
| Secondary | Objective Response Rate according to RECIST v1.1 | Approximately 2 years | ||
| Secondary | Duration of Response according to RECIST v1.1 | Approximately 2 years | ||
| Secondary | Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm | Approximately 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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