Clinical trial NCT02399137: A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Front-line Pancreatic Cancer
Metastatic Pancreatic Cancer
Gemcitabine
Nab-paclitaxel
Abraxane
Free IGF-1
Heregulin
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Approximately 2.5 years
measure: Objective Response Rate according to RECIST v1.1
timeFrame: Approximately 2 years
measure: Duration of Response according to RECIST v1.1
timeFrame: Approximately 2 years
measure: Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Ctr.
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Assoc Med Grp
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Med Onc Corp
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Miami
country: United States
facility: Baptist Health Med Gr Onc, LLC
state: Florida
city: Ocala
country: United States
facility: Florida Cancer AffiliatesOcala
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Newnan
country: United States
facility: Cancer Treatment Centers of America-Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Zion
country: United States
facility: Midwest Regional Medical Cntr
state: Illinois
city: Sioux City
country: United States
facility: Nylen Cancer Center
state: Iowa
city: Lafayette
country: United States
facility: Cancer Center of Acadiana Research Department
state: Louisiana
city: Worcester
country: United States
facility: Reliant Medical Group, Inc.
state: Massachusetts
city: Henderson
country: United States
facility: Compr Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology HematologyPC
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Inst
state: New York
city: Cooperstown
country: United States
facility: Bassett Cancer Institute
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates, PC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Columbus
country: United States
facility: Mid Ohio Onco/ Zangmeister Ctr
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Cancer Institute, PLLC
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Ctr
state: Tennessee
city: Nashville
country: United States
facility: SCRI - Tennessee Oncology
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Midtown
state: Texas
city: Bedford
country: United States
facility: Texas Oncology P A Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas P.H.
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center (BAMC)
state: Texas
city: Paris
country: United States
facility: Texas Oncology-Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology SA Medical Ctr
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists PC
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Asso of SW VA Inc
state: Virginia
city: Spokane Valley
country: United States
facility: Cancer Care Northwest, P.S.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer SpecialistsPC
state: Washington
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Munchen
country: Germany
facility: Klinikum rechts der Isar - TUM
state: Bayern
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Saarbruecken
country: Germany
facility: Caritasklinik St. Theresia
state: Saarland
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoelln
city: Berlin
country: Germany
facility: Charite Universitaetsmd Berlin
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Torun
country: Poland
facility: WSZ im. L. Rydygiera wToruniu
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: Hospital U de Fuenlabrada
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Greater London
city: Manchester
country: United Kingdom
facility: The Christie
state: Greater Manchester
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Merrimack Pharmaceuticals
name: MM-141 Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.