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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MM-141
Placebo
Gemcitabine
Nab-Paclitaxel
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Front-line Pancreatic Cancer, Metastatic Pancreatic Cancer, Gemcitabine, Nab-paclitaxel, Abraxane, Free IGF-1, Heregulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer Ctr.
  • Pacific Cancer Medical Center, Inc.
  • St. Jude Heritage Healthcare
  • UCLA School of Medicine
  • Cancer Care Assoc Med Grp
  • UCSF Cancer Center
  • Sansum Clinic
  • Central Coast Med Onc Corp
  • Rocky Mountain Cancer Centers
  • Baptist Health Med Gr Onc, LLC
  • Florida Cancer AffiliatesOcala
  • Memorial Regional Hospital
  • Cancer Treatment Centers of America-Georgia
  • Northwestern University
  • University of Illinois at Chicago
  • Illinois Cancer Specialists
  • Oncology Specialists, S.C.
  • Midwest Regional Medical Cntr
  • Nylen Cancer Center
  • Cancer Center of Acadiana Research Department
  • Reliant Medical Group, Inc.
  • Compr Cancer Centers of Nevada
  • New York Oncology HematologyPC
  • Roswell Park Cancer Inst
  • Bassett Cancer Institute
  • North Shore Hematology Oncology Associates, PC
  • Columbia University Medical Center
  • Columbia University
  • Mid Ohio Onco/ Zangmeister Ctr
  • Tulsa Cancer Institute, PLLC
  • St. Luke's University Health Network
  • Fox Chase Cancer Center
  • Allegheny Cancer Center
  • Vanderbilt-Ingram Cancer Ctr
  • SCRI - Tennessee Oncology
  • Texas Oncology-Austin Midtown
  • Texas Oncology P A Bedford
  • Texas Oncology-Dallas P.H.
  • Brooke Army Medical Center (BAMC)
  • Texas Oncology-Paris
  • Texas Oncology-Plano East
  • Texas Oncology SA Medical Ctr
  • Texas Oncology-Tyler
  • Virginia Cancer Specialists PC
  • Onc and Hem Asso of SW VA Inc
  • Cancer Care Northwest, P.S.
  • Northwest Cancer SpecialistsPC
  • Cross Cancer Institute
  • Klinikum rechts der Isar - TUM
  • Universitaetsklinikum Koeln
  • Caritasklinik St. Theresia
  • Vivantes Klinikum Neukoelln
  • Charite Universitaetsmd Berlin
  • Uniwersyteckie Centrum Kliniczne
  • WSZ im. L. Rydygiera wToruniu
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitari Vall d'Hebron
  • Hospital General Universitario Gregorio Marañon
  • Centro Integral Oncologico Clara Campal
  • Hospital U de Fuenlabrada
  • Hospital Clinico Universitario de Valencia
  • Guy's Hospital
  • Sarah Cannon Research Institute UK
  • The Christie
  • Royal Marsden Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Arm A (Experimental Arm)

Arm B (Comparator Arm)

Observational Group

Arm Description

MM-141 in combination with nab-paclitaxel and gemcitabine

Placebo in combination with nab-paclitaxel and gemcitabine

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Survival
Objective Response Rate according to RECIST v1.1
Duration of Response according to RECIST v1.1
Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm

Full Information

First Posted
March 19, 2015
Last Updated
September 17, 2018
Sponsor
Merrimack Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02399137
Brief Title
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
Acronym
CARRIE
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Front-line Pancreatic Cancer, Metastatic Pancreatic Cancer, Gemcitabine, Nab-paclitaxel, Abraxane, Free IGF-1, Heregulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Experimental Arm)
Arm Type
Experimental
Arm Description
MM-141 in combination with nab-paclitaxel and gemcitabine
Arm Title
Arm B (Comparator Arm)
Arm Type
Active Comparator
Arm Description
Placebo in combination with nab-paclitaxel and gemcitabine
Arm Title
Observational Group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
MM-141
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Other Intervention Name(s)
Abraxane
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Approximately 2.5 years
Title
Objective Response Rate according to RECIST v1.1
Time Frame
Approximately 2 years
Title
Duration of Response according to RECIST v1.1
Time Frame
Approximately 2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MM-141 Medical Director, MD
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Ctr.
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cancer Care Assoc Med Grp
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UCSF Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Med Onc Corp
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Baptist Health Med Gr Onc, LLC
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida Cancer AffiliatesOcala
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Memorial Regional Hospital
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Cancer Treatment Centers of America-Georgia
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Cancer Specialists
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Midwest Regional Medical Cntr
City
Zion
State/Province
Illinois
Country
United States
Facility Name
Nylen Cancer Center
City
Sioux City
State/Province
Iowa
Country
United States
Facility Name
Cancer Center of Acadiana Research Department
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Reliant Medical Group, Inc.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Compr Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
New York Oncology HematologyPC
City
Albany
State/Province
New York
Country
United States
Facility Name
Roswell Park Cancer Inst
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Bassett Cancer Institute
City
Cooperstown
State/Province
New York
Country
United States
Facility Name
North Shore Hematology Oncology Associates, PC
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mid Ohio Onco/ Zangmeister Ctr
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Tulsa Cancer Institute, PLLC
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
SCRI - Tennessee Oncology
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology-Austin Midtown
City
Austin
State/Province
Texas
Country
United States
Facility Name
Texas Oncology P A Bedford
City
Bedford
State/Province
Texas
Country
United States
Facility Name
Texas Oncology-Dallas P.H.
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Brooke Army Medical Center (BAMC)
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Texas Oncology-Paris
City
Paris
State/Province
Texas
Country
United States
Facility Name
Texas Oncology-Plano East
City
Plano
State/Province
Texas
Country
United States
Facility Name
Texas Oncology SA Medical Ctr
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Virginia Cancer Specialists PC
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Onc and Hem Asso of SW VA Inc
City
Salem
State/Province
Virginia
Country
United States
Facility Name
Cancer Care Northwest, P.S.
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Northwest Cancer SpecialistsPC
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Klinikum rechts der Isar - TUM
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Caritasklinik St. Theresia
City
Saarbruecken
State/Province
Saarland
ZIP/Postal Code
66113
Country
Germany
Facility Name
Vivantes Klinikum Neukoelln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Charite Universitaetsmd Berlin
City
Berlin
Country
Germany
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
WSZ im. L. Rydygiera wToruniu
City
Torun
Country
Poland
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital U de Fuenlabrada
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Guy's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Christie
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31912800
Citation
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. Erratum In: Ann Oncol. 2020 Aug;31(8):1094.
Results Reference
derived

Learn more about this trial

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

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