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

Sponsor
Merrimack Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02399137
Collaborator
(none)
88
Enrollment
66
Locations
3
Arms
39
Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (Experimental Arm)

MM-141 in combination with nab-paclitaxel and gemcitabine

Drug: MM-141

Drug: Gemcitabine
Other Names:
  • Gemzar

    • Drug: Nab-Paclitaxel
    Other Names:
  • Abraxane

    		•
    Active Comparator: Arm B (Comparator Arm)

    Placebo in combination with nab-paclitaxel and gemcitabine

    Drug: Placebo

    Drug: Gemcitabine
    Other Names:
  • Gemzar

    • Drug: Nab-Paclitaxel
    Other Names:
  • Abraxane

    		•
    No Intervention: Observational Group

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [Approximately 2 years]

    Secondary Outcome Measures

    1. Overall Survival [Approximately 2.5 years]

    2. Objective Response Rate according to RECIST v1.1 [Approximately 2 years]

    3. Duration of Response according to RECIST v1.1 [Approximately 2 years]

    4. Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm [Approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Ctr. Gilbert Arizona United States 85234
    2 Pacific Cancer Medical Center, Inc. Anaheim California United States 92801
    3 St. Jude Heritage Healthcare Fullerton California United States 92835
    4 UCLA School of Medicine Los Angeles California United States 90095
    5 Cancer Care Assoc Med Grp Redondo Beach California United States 90277
    6 UCSF Cancer Center San Francisco California United States 94115
    7 Sansum Clinic Santa Barbara California United States 93105
    8 Central Coast Med Onc Corp Santa Maria California United States 93454
    9 Rocky Mountain Cancer Centers Aurora Colorado United States
    10 Baptist Health Med Gr Onc, LLC Miami Florida United States
    11 Florida Cancer AffiliatesOcala Ocala Florida United States
    12 Memorial Regional Hospital Pembroke Pines Florida United States 33028
    13 Cancer Treatment Centers of America-Georgia Newnan Georgia United States 30265
    14 Northwestern University Chicago Illinois United States 60611
    15 University of Illinois at Chicago Chicago Illinois United States 60612
    16 Illinois Cancer Specialists Chicago Illinois United States
    17 Oncology Specialists, S.C. Park Ridge Illinois United States 60068
    18 Midwest Regional Medical Cntr Zion Illinois United States
    19 Nylen Cancer Center Sioux City Iowa United States
    20 Cancer Center of Acadiana Research Department Lafayette Louisiana United States 70503
    21 Reliant Medical Group, Inc. Worcester Massachusetts United States 01608
    22 Compr Cancer Centers of Nevada Henderson Nevada United States
    23 New York Oncology HematologyPC Albany New York United States
    24 Roswell Park Cancer Inst Buffalo New York United States 14263
    25 Bassett Cancer Institute Cooperstown New York United States
    26 North Shore Hematology Oncology Associates, PC East Setauket New York United States 11733
    27 Columbia University Medical Center New York New York United States 10032
    28 Columbia University New York New York United States 10032
    29 Mid Ohio Onco/ Zangmeister Ctr Columbus Ohio United States
    30 Tulsa Cancer Institute, PLLC Tulsa Oklahoma United States
    31 St. Luke's University Health Network Bethlehem Pennsylvania United States 18015
    32 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    33 Allegheny Cancer Center Pittsburgh Pennsylvania United States
    34 Vanderbilt-Ingram Cancer Ctr Nashville Tennessee United States 37232
    35 SCRI - Tennessee Oncology Nashville Tennessee United States
    36 Texas Oncology-Austin Midtown Austin Texas United States
    37 Texas Oncology P A Bedford Bedford Texas United States
    38 Texas Oncology-Dallas P.H. Dallas Texas United States
    39 Brooke Army Medical Center (BAMC) Fort Sam Houston Texas United States 78234
    40 Texas Oncology-Paris Paris Texas United States
    41 Texas Oncology-Plano East Plano Texas United States
    42 Texas Oncology SA Medical Ctr San Antonio Texas United States
    43 Texas Oncology-Tyler Tyler Texas United States
    44 Virginia Cancer Specialists PC Fairfax Virginia United States
    45 Onc and Hem Asso of SW VA Inc Salem Virginia United States
    46 Cancer Care Northwest, P.S. Spokane Valley Washington United States 99216
    47 Northwest Cancer SpecialistsPC Vancouver Washington United States
    48 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    49 Klinikum rechts der Isar - TUM Munchen Bayern Germany 81675
    50 Universitaetsklinikum Koeln Koeln Nordrhein Westfalen Germany 50937
    51 Caritasklinik St. Theresia Saarbruecken Saarland Germany 66113
    52 Vivantes Klinikum Neukoelln Berlin Germany 12351
    53 Charite Universitaetsmd Berlin Berlin Germany
    54 Uniwersyteckie Centrum Kliniczne Gdansk Poland
    55 WSZ im. L. Rydygiera wToruniu Torun Poland
    56 Hospital Universitario Marques de Valdecilla Santander Cantabria Spain 39008
    57 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    58 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    59 Centro Integral Oncologico Clara Campal Madrid Spain 28050
    60 Hospital U de Fuenlabrada Madrid Spain
    61 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    62 Guy's Hospital London Greater London United Kingdom SE1 9RT
    63 Sarah Cannon Research Institute UK London Greater London United Kingdom W1G 6AD
    64 The Christie Manchester Greater Manchester United Kingdom M20 4BX
    65 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT
    66 Royal Marsden Hospital Sutton United Kingdom

    Sponsors and Collaborators

    • Merrimack Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merrimack Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02399137
    Other Study ID Numbers:
    • MM-141-07-02-02
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Merrimack Pharmaceuticals
    Pancreatic Cancer
    Front-line Pancreatic Cancer
    Metastatic Pancreatic Cancer
    Gemcitabine
    Nab-paclitaxel
    Abraxane
    Free IGF-1
    Heregulin
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine
    Paclitaxel

    Study Results

    No Results Posted as of Sep 18, 2018