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

September 17, 2018 updated by: Merrimack Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
  • Germany
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukoelln
      • Berlin, Germany
        • Charite Universitaetsmd Berlin
    • Bayern
      • Munchen, Bayern, Germany, 81675
        • Klinikum rechts der Isar - TUM
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Universitaetsklinikum Koeln
    • Saarland
      • Saarbruecken, Saarland, Germany, 66113
        • Caritasklinik St. Theresia
  • Poland
      • Gdansk, Poland
        • Uniwersyteckie Centrum Kliniczne
      • Torun, Poland
        • WSZ im. L. Rydygiera wToruniu
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Centro Integral Oncológico Clara Campal
      • Madrid, Spain
        • Hospital U de Fuenlabrada
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
  • United Kingdom
      • Sutton, United Kingdom
        • Royal Marsden Hospital
    • Greater London
      • London, Greater London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Ctr.
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Fullerton, California, United States, 92835
        • St. Jude Heritage Healthcare
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • Redondo Beach, California, United States, 90277
        • Cancer Care Assoc Med Grp
      • San Francisco, California, United States, 94115
        • UCSF Cancer Center
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Santa Maria, California, United States, 93454
        • Central Coast Med Onc Corp
    • Colorado
      • Aurora, Colorado, United States
        • Rocky Mountain Cancer Centers
    • Florida
      • Miami, Florida, United States
        • Baptist Health Med Gr Onc, LLC
      • Ocala, Florida, United States
        • Florida Cancer AffiliatesOcala
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Regional Hospital
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Cancer Treatment Centers of America-Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States
        • Illinois Cancer Specialists
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
      • Zion, Illinois, United States
        • Midwest Regional Medical Cntr
    • Iowa
      • Sioux City, Iowa, United States
        • Nylen Cancer Center
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Cancer Center of Acadiana Research Department
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Reliant Medical Group, Inc.
    • Nevada
      • Henderson, Nevada, United States
        • Compr Cancer Centers of Nevada
    • New York
      • Albany, New York, United States
        • New York Oncology HematologyPC
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Inst
      • Cooperstown, New York, United States
        • Bassett Cancer Institute
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates, PC
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Columbus, Ohio, United States
        • Mid Ohio Onco/ Zangmeister Ctr
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Tulsa Cancer Institute, PLLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States
        • Allegheny Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Ctr
      • Nashville, Tennessee, United States
        • SCRI - Tennessee Oncology
    • Texas
      • Austin, Texas, United States
        • Texas Oncology-Austin Midtown
      • Bedford, Texas, United States
        • Texas Oncology P A Bedford
      • Dallas, Texas, United States
        • Texas Oncology-Dallas P.H.
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center (BAMC)
      • Paris, Texas, United States
        • Texas Oncology-Paris
      • Plano, Texas, United States
        • Texas Oncology-Plano East
      • San Antonio, Texas, United States
        • Texas Oncology SA Medical Ctr
      • Tyler, Texas, United States
        • Texas Oncology-Tyler
    • Virginia
      • Fairfax, Virginia, United States
        • Virginia Cancer Specialists PC
      • Salem, Virginia, United States
        • Onc and Hem Asso of SW VA Inc
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest, P.S.
      • Vancouver, Washington, United States
        • Northwest Cancer SpecialistsPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: MM-141
Drug: Nab-Paclitaxel
Other Names:
  • Abraxane
Active Comparator: Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Placebo
Drug: Nab-Paclitaxel
Other Names:
  • Abraxane
No Intervention: Observational Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Approximately 2 years
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Approximately 2.5 years
Approximately 2.5 years
Objective Response Rate according to RECIST v1.1
Time Frame: Approximately 2 years
Approximately 2 years
Duration of Response according to RECIST v1.1
Time Frame: Approximately 2 years
Approximately 2 years
Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm
Time Frame: Approximately 2 years
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Investigators

  • Study Director: MM-141 Medical Director, MD, Merrimack Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-141-07-02-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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