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NCT Number: NCT02399137

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fibromatosis, Gingival, 2 Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MM-141

Drug

Placebo

Drug

Gemcitabine

Drug

Other names: Gemzar

Nab-paclitaxel

Drug

Other names: Abraxane

Primary outcomes

  1. Progression Free Survival

    Time frame: Approximately 2 years

Secondary outcomes

  1. Overall Survival

    Time frame: Approximately 2.5 years

  2. Objective Response Rate according to RECIST v1.1

    Time frame: Approximately 2 years

  3. Duration of Response according to RECIST v1.1

    Time frame: Approximately 2 years

  4. 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

Sponsors and collaborators

Lead sponsor

Merrimack Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: CARRIE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2015
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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