A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

NCT ID: NCT02399137

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A (Experimental Arm)

MM-141 in combination with nab-paclitaxel and gemcitabine

Group Type EXPERIMENTAL

MM-141

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Nab-Paclitaxel

Intervention Type DRUG

Arm B (Comparator Arm)

Placebo in combination with nab-paclitaxel and gemcitabine

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Nab-Paclitaxel

Intervention Type DRUG

Observational Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MM-141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Nab-Paclitaxel

Intervention Type DRUG

Other Intervention Names

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Gemzar Abraxane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MM-141 Medical Director, MD

Role: STUDY_DIRECTOR

Merrimack Pharmaceuticals

Locations

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Banner MD Anderson Cancer Ctr.

Gilbert, Arizona, United States

Site Status

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Site Status

St. Jude Heritage Healthcare

Fullerton, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Cancer Care Assoc Med Grp

Redondo Beach, California, United States

Site Status

UCSF Cancer Center

San Francisco, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

Central Coast Med Onc Corp

Santa Maria, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

Baptist Health Med Gr Onc, LLC

Miami, Florida, United States

Site Status

Florida Cancer AffiliatesOcala

Ocala, Florida, United States

Site Status

Memorial Regional Hospital

Pembroke Pines, Florida, United States

Site Status

Cancer Treatment Centers of America-Georgia

Newnan, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Illinois Cancer Specialists

Chicago, Illinois, United States

Site Status

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Site Status

Midwest Regional Medical Cntr

Zion, Illinois, United States

Site Status

Nylen Cancer Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Acadiana Research Department

Lafayette, Louisiana, United States

Site Status

Reliant Medical Group, Inc.

Worcester, Massachusetts, United States

Site Status

Compr Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

New York Oncology HematologyPC

Albany, New York, United States

Site Status

Roswell Park Cancer Inst

Buffalo, New York, United States

Site Status

Bassett Cancer Institute

Cooperstown, New York, United States

Site Status

North Shore Hematology Oncology Associates, PC

East Setauket, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Mid Ohio Onco/ Zangmeister Ctr

Columbus, Ohio, United States

Site Status

Tulsa Cancer Institute, PLLC

Tulsa, Oklahoma, United States

Site Status

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee, United States

Site Status

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Texas Oncology-Austin Midtown

Austin, Texas, United States

Site Status

Texas Oncology P A Bedford

Bedford, Texas, United States

Site Status

Texas Oncology-Dallas P.H.

Dallas, Texas, United States

Site Status

Brooke Army Medical Center (BAMC)

Fort Sam Houston, Texas, United States

Site Status

Texas Oncology-Paris

Paris, Texas, United States

Site Status

Texas Oncology-Plano East

Plano, Texas, United States

Site Status

Texas Oncology SA Medical Ctr

San Antonio, Texas, United States

Site Status

Texas Oncology-Tyler

Tyler, Texas, United States

Site Status

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Site Status

Onc and Hem Asso of SW VA Inc

Salem, Virginia, United States

Site Status

Cancer Care Northwest, P.S.

Spokane Valley, Washington, United States

Site Status

Northwest Cancer SpecialistsPC

Vancouver, Washington, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Klinikum rechts der Isar - TUM

München, Bavaria, Germany

Site Status

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

Site Status

Caritasklinik St. Theresia

Saarbrücken, Saarland, Germany

Site Status

Vivantes Klinikum Neukoelln

Berlin, , Germany

Site Status

Charite Universitaetsmd Berlin

Berlin, , Germany

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

WSZ im. L. Rydygiera wToruniu

Torun, , Poland

Site Status

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status

Hospital U de Fuenlabrada

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Guy's Hospital

London, Greater London, United Kingdom

Site Status

Sarah Cannon Research Institute UK

London, Greater London, United Kingdom

Site Status

The Christie

Manchester, Greater Manchester, United Kingdom

Site Status

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status

Royal Marsden Hospital

Sutton, , United Kingdom

Site Status

Countries

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United States Canada Germany Poland Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31912800 (View on PubMed)

Other Identifiers

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MM-141-07-02-02

Identifier Type: -

Identifier Source: org_study_id

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