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

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02399137

MM-141-07-02-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 3 patient groups

Arm A (Experimental Arm)

Experimental group

Description:

MM-141 in combination with nab-paclitaxel and gemcitabine

Treatment:

Drug: Nab-Paclitaxel

Drug: MM-141

Drug: Gemcitabine

Arm B (Comparator Arm)

Active Comparator group

Description:

Placebo in combination with nab-paclitaxel and gemcitabine

Treatment:

Drug: Nab-Paclitaxel

Drug: Gemcitabine

Drug: Placebo

Observational Group

No Intervention group