A Phase 2 Study Of MM-141 Plus Nab-paclitaxel And Gemcitabine In Front-line Metastatic Pancreatic Cancer

Study Overview

A Phase 2 Study of MM-141 Plus 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.

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.

Pancreatic Cancer

DRUG: MM-141
DRUG: Placebo
DRUG: Gemcitabine
DRUG: Nab-Paclitaxel

MM-141-07-02-02

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-09-17
First Submitted that Met QC Criteria 2015-03-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-09-18
First Posted (ACTUAL) 2015-03-26	Results First Posted N/A	Last Verified 2018-09

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

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: MM-141 DRUG: Gemcitabine DRUG: Nab-Paclitaxel
ACTIVE_COMPARATOR: Arm B (Comparator Arm) Placebo in combination with nab-paclitaxel and gemcitabine	DRUG: Placebo DRUG: Gemcitabine DRUG: Nab-Paclitaxel
NO_INTERVENTION: Observational Group

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A (Experimental Arm)

MM-141 in combination with nab-paclitaxel and gemcitabine

DRUG: MM-141

DRUG: Gemcitabine

DRUG: Nab-Paclitaxel

ACTIVE_COMPARATOR: Arm B (Comparator Arm)

Placebo in combination with nab-paclitaxel and gemcitabine

DRUG: Placebo

DRUG: Gemcitabine

DRUG: Nab-Paclitaxel

NO_INTERVENTION: Observational Group

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival		Approximately 2 years

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: MM-141 Medical Director, MD, Merrimack Pharmaceuticals

Publications

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

General 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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record