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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Experimental Arm) | Experimental | MM-141 in combination with nab-paclitaxel and gemcitabine |
|
| Arm B (Comparator Arm) | Active Comparator | Placebo in combination with nab-paclitaxel and gemcitabine |
|
| Observational Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-141 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Approximately 2.5 years | |
| Objective Response Rate according to RECIST v1.1 | Approximately 2 years | |
| Duration of Response according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MM-141 Medical Director, MD | Merrimack Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Ctr. | Gilbert | Arizona | 85234 | United States | ||
| Pacific Cancer Medical Center, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31912800 | Derived | Kundranda M, Gracian AC, Zafar SF, Meiri E, Bendell J, Algul H, Rivera F, Ahn ER, Watkins D, Pelzer U, Charu V, Zalutskaya A, Kuesters G, Pipas JM, Santillana S, Askoxylakis V, Ko AH. Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE). Ann Oncol. 2020 Jan;31(1):79-87. doi: 10.1016/j.annonc.2019.09.004. |
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|
| Gemcitabine | Drug |
|
|
| Nab-Paclitaxel | Drug |
|
|
| 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 |
| Anaheim |
| California |
| 92801 |
| United States |
| St. Jude Heritage Healthcare | Fullerton | California | 92835 | United States |
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| Cancer Care Assoc Med Grp | Redondo Beach | California | 90277 | United States |
| UCSF Cancer Center | San Francisco | California | 94115 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Central Coast Med Onc Corp | Santa Maria | California | 93454 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 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 | 33028 | United States |
| Cancer Treatment Centers of America-Georgia | Newnan | Georgia | 30265 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Illinois Cancer Specialists | Chicago | Illinois | United States |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | United States |
| Midwest Regional Medical Cntr | Zion | Illinois | United States |
| Nylen Cancer Center | Sioux City | Iowa | United States |
| Cancer Center of Acadiana Research Department | Lafayette | Louisiana | 70503 | United States |
| Reliant Medical Group, Inc. | Worcester | Massachusetts | 01608 | United States |
| Compr Cancer Centers of Nevada | Henderson | Nevada | United States |
| New York Oncology HematologyPC | Albany | New York | United States |
| Roswell Park Cancer Inst | Buffalo | New York | 14263 | United States |
| Bassett Cancer Institute | Cooperstown | New York | United States |
| North Shore Hematology Oncology Associates, PC | East Setauket | New York | 11733 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Mid Ohio Onco/ Zangmeister Ctr | Columbus | Ohio | United States |
| Tulsa Cancer Institute, PLLC | Tulsa | Oklahoma | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | United States |
| Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee | 37232 | United States |
| SCRI - Tennessee Oncology | Nashville | Tennessee | United States |
| Texas Oncology-Austin Midtown | Austin | Texas | United States |
| Texas Oncology P A Bedford | Bedford | Texas | United States |
| Texas Oncology-Dallas P.H. | Dallas | Texas | United States |
| Brooke Army Medical Center (BAMC) | Fort Sam Houston | Texas | 78234 | United States |
| Texas Oncology-Paris | Paris | Texas | United States |
| Texas Oncology-Plano East | Plano | Texas | United States |
| Texas Oncology SA Medical Ctr | San Antonio | Texas | United States |
| Texas Oncology-Tyler | Tyler | Texas | United States |
| Virginia Cancer Specialists PC | Fairfax | Virginia | United States |
| Onc and Hem Asso of SW VA Inc | Salem | Virginia | United States |
| Cancer Care Northwest, P.S. | Spokane Valley | Washington | 99216 | United States |
| Northwest Cancer SpecialistsPC | Vancouver | Washington | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Klinikum rechts der Isar - TUM | München | Bavaria | 81675 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Caritasklinik St. Theresia | Saarbrücken | Saarland | 66113 | Germany |
| Vivantes Klinikum Neukoelln | Berlin | 12351 | Germany |
| Charite Universitaetsmd Berlin | Berlin | Germany |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| WSZ im. L. Rydygiera wToruniu | Torun | Poland |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital U de Fuenlabrada | Madrid | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Guy's Hospital | London | Greater London | SE1 9RT | United Kingdom |
| Sarah Cannon Research Institute UK | London | Greater London | W1G 6AD | United Kingdom |
| The Christie | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| Royal Marsden Hospital | Sutton | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| C565323 | Fibromatosis, Gingival, 2 |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000595155 | Istiratumab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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