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Pancreatic CancerPhase 2CARRIENCT02399137

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

A Phase 2 study testing MM-141, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Merrimack Pharmaceuticals at 66 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
MM-141, Gemcitabine and Nab-Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
66 sitesin 6 countries
Study dates
May 2015to Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients who only present with localized disease
  • Patients with CNS malignancies (primary or metastatic)
  • Clinically significant cardiac disease

Trial locations and contacts

66 sites in 6 countries.

66 sites in 6 countries

United States47 sites

  • New York Oncology HematologyPC

    Albany, New York

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Rocky Mountain Cancer Centers

    Aurora, Colorado

  • Texas Oncology-Austin Midtown

    Austin, Texas

  • Texas Oncology P A Bedford

    Bedford, Texas

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • Roswell Park Cancer Inst

    Buffalo, New York, 14263

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Illinois Cancer Specialists

    Chicago, Illinois

  • Mid Ohio Onco/ Zangmeister Ctr

    Columbus, Ohio

  • Bassett Cancer Institute

    Cooperstown, New York

  • Texas Oncology-Dallas P.H.

    Dallas, Texas

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Virginia Cancer Specialists PC

    Fairfax, Virginia

  • Brooke Army Medical Center (BAMC)

    Fort Sam Houston, Texas, 78234

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Banner MD Anderson Cancer Ctr.

    Gilbert, Arizona, 85234

  • Compr Cancer Centers of Nevada

    Henderson, Nevada

  • Cancer Center of Acadiana Research Department

    Lafayette, Louisiana, 70503

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Baptist Health Med Gr Onc, LLC

    Miami, Florida

  • Vanderbilt-Ingram Cancer Ctr

    Nashville, Tennessee, 37232

  • SCRI - Tennessee Oncology

    Nashville, Tennessee

  • Columbia University Medical Center

    New York, New York, 10032

  • Columbia University

    New York, New York, 10032

  • Cancer Treatment Centers of America-Georgia

    Newnan, Georgia, 30265

  • Florida Cancer AffiliatesOcala

    Ocala, Florida

  • Texas Oncology-Paris

    Paris, Texas

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Memorial Regional Hospital

    Pembroke Pines, Florida, 33028

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania

  • Texas Oncology-Plano East

    Plano, Texas

  • Cancer Care Assoc Med Grp

    Redondo Beach, California, 90277

  • Onc and Hem Asso of SW VA Inc

    Salem, Virginia

  • Texas Oncology SA Medical Ctr

    San Antonio, Texas

  • UCSF Cancer Center

    San Francisco, California, 94115

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Central Coast Med Onc Corp

    Santa Maria, California, 93454

  • Nylen Cancer Center

    Sioux City, Iowa

  • Cancer Care Northwest, P.S.

    Spokane Valley, Washington, 99216

  • Tulsa Cancer Institute, PLLC

    Tulsa, Oklahoma

  • Texas Oncology-Tyler

    Tyler, Texas

  • Northwest Cancer SpecialistsPC

    Vancouver, Washington

  • Reliant Medical Group, Inc.

    Worcester, Massachusetts, 01608

  • Midwest Regional Medical Cntr

    Zion, Illinois

Other trials in United States

Spain6 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital U de Fuenlabrada

    Madrid

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Germany5 sites

  • Vivantes Klinikum Neukoelln

    Berlin, 12351

  • Charite Universitaetsmd Berlin

    Berlin

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Klinikum rechts der Isar - TUM

    München, Bavaria, 81675

  • Caritasklinik St. Theresia

    Saarbrücken, Saarland, 66113

Other trials in Germany

United Kingdom5 sites

  • Guy's Hospital

    London, Greater London, SE1 9RT

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • Royal Marsden Hospital

    Sutton

Other trials in United Kingdom

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • WSZ im. L. Rydygiera wToruniu

    Torun

Other trials in Poland

Canada1 site

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
MM-141, Placebo, Gemcitabine, Nab-Paclitaxel
Keywords
Pancreatic Cancer, Front-line Pancreatic Cancer, Metastatic Pancreatic Cancer, Gemcitabine, Nab-paclitaxel, Abraxane, Free IGF-1, Heregulin
Medical subject headings
Pancreatic Neoplasms, Fibromatosis, Gingival, 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02399137
Study groupRoleWhat they receive
Arm A (Experimental Arm)ExperimentalMM-141 in combination with nab-paclitaxel and gemcitabine
Receives: Drug: MM-141; Drug: Gemcitabine; Drug: Nab-Paclitaxel
Arm B (Comparator Arm)Active comparatorPlacebo in combination with nab-paclitaxel and gemcitabine
Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Nab-Paclitaxel
Observational GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: Approximately 2 years

Secondary outcomes (4)

  1. Overall Survival

    Measured: Approximately 2.5 years

  2. Objective Response Rate according to RECIST v1.1

    Measured: Approximately 2 years

  3. Duration of Response according to RECIST v1.1

    Measured: Approximately 2 years

  4. Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399137
Sponsor's protocol ID
MM-141-07-02-02
Acronym
CARRIE
Status last verified
Sep 2018
First submitted
19 Mar 2015
Last updated
18 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31912800

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MM-141, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Merrimack Pharmaceuticals at 66 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Spain, Germany, United Kingdom, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02399137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.

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