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

NCT02399137 | Completed Phase 2 DMC

• 1 other identifier: MM-141-07-02-02
• Study Type: interventional
• Target: 88
• Locations: 6 countries
• Sites: 66

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Front-line Pancreatic Cancer; Metastatic Pancreatic Cancer; Gemcitabine; Nab-paclitaxel; Abraxane; Free IGF-1; Heregulin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Approximately 2 years

Secondary Outcomes (4)

• 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

  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

Study Arms (3)

Arm A (Experimental Arm)

EXPERIMENTAL

MM-141 in combination with nab-paclitaxel and gemcitabine

Drug: MM-141; Drug: Gemcitabine; Drug: Nab-Paclitaxel

Arm B (Comparator Arm)

ACTIVE COMPARATOR

Placebo in combination with nab-paclitaxel and gemcitabine

Drug: Placebo; Drug: Gemcitabine; Drug: Nab-Paclitaxel

Observational Group

NO INTERVENTION

Interventions

MM-141 DRUG

Arm A (Experimental Arm)

Placebo DRUG

Arm B (Comparator Arm)

Gemcitabine DRUG

Also known as: Gemzar

Arm A (Experimental Arm); Arm B (Comparator Arm)

Nab-Paclitaxel DRUG

Also known as: Abraxane

Arm A (Experimental Arm); Arm B (Comparator Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (66)

Banner MD Anderson Cancer Ctr.

Gilbert, Arizona, 85234, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

St. Jude Heritage Healthcare

Fullerton, California, 92835, United States

Location

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Cancer Care Assoc Med Grp

Redondo Beach, California, 90277, United States

Location

UCSF Cancer Center

San Francisco, California, 94115, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Central Coast Med Onc Corp

Santa Maria, California, 93454, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Location

Baptist Health Med Gr Onc, LLC

Miami, Florida, United States

Location

Florida Cancer AffiliatesOcala

Ocala, Florida, United States

Location

Memorial Regional Hospital

Pembroke Pines, Florida, 33028, United States

Location

Cancer Treatment Centers of America-Georgia

Newnan, Georgia, 30265, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Illinois Cancer Specialists

Chicago, Illinois, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Midwest Regional Medical Cntr

Zion, Illinois, United States

Location

Nylen Cancer Center

Sioux City, Iowa, United States

Location

Cancer Center of Acadiana Research Department

Lafayette, Louisiana, 70503, United States

Location

Reliant Medical Group, Inc.

Worcester, Massachusetts, 01608, United States

Location

Compr Cancer Centers of Nevada

Henderson, Nevada, United States

Location

New York Oncology HematologyPC

Albany, New York, United States

Location

Roswell Park Cancer Inst

Buffalo, New York, 14263, United States

Location

Bassett Cancer Institute

Cooperstown, New York, United States

Location

North Shore Hematology Oncology Associates, PC

East Setauket, New York, 11733, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Mid Ohio Onco/ Zangmeister Ctr

Columbus, Ohio, United States

Location

Tulsa Cancer Institute, PLLC

Tulsa, Oklahoma, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Location

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee, 37232, United States

Location

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

Location

Texas Oncology-Austin Midtown

Austin, Texas, United States

Location

Texas Oncology P A Bedford

Bedford, Texas, United States

Location

Texas Oncology-Dallas P.H.

Dallas, Texas, United States

Location

Brooke Army Medical Center (BAMC)

Fort Sam Houston, Texas, 78234, United States

Location

Texas Oncology-Paris

Paris, Texas, United States

Location

Texas Oncology-Plano East

Plano, Texas, United States

Location

Texas Oncology SA Medical Ctr

San Antonio, Texas, United States

Location

Texas Oncology-Tyler

Tyler, Texas, United States

Location

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Location

Onc and Hem Asso of SW VA Inc

Salem, Virginia, United States

Location

Cancer Care Northwest, P.S.

Spokane Valley, Washington, 99216, United States

Location

Northwest Cancer SpecialistsPC

Vancouver, Washington, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Klinikum rechts der Isar - TUM

München, Bavaria, 81675, Germany

Location

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Caritasklinik St. Theresia

Saarbrücken, Saarland, 66113, Germany

Location

Vivantes Klinikum Neukoelln

Berlin, 12351, Germany

Location

Charite Universitaetsmd Berlin

Berlin, Germany

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

WSZ im. L. Rydygiera wToruniu

Torun, Poland

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Hospital U de Fuenlabrada

Madrid, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Guy's Hospital

London, Greater London, SE1 9RT, United Kingdom

Location

Sarah Cannon Research Institute UK

London, Greater London, W1G 6AD, United Kingdom

Location

The Christie

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Royal Marsden Hospital

Sutton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31912800 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Fibromatosis, Gingival, 2

Interventions

Istiratumab; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MM-141 Medical Director, MD

  Merrimack Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 26, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

CA (1); DE (5); ES (6); US (47); PL (2); GB (5)