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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: MM-141
* Drug: Placebo
* Drug: Gemcitabine
* Drug: Nab-Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Experimental Arm)<br>MM-141 in combination with nab-paclitaxel and gemcitabine | Drug: MM-141<br> <br> Drug: Gemcitabine<br> <br> * Other names: Gemzar;Drug: Nab-Paclitaxel<br> <br> * Other names: Abraxane;|
| Active Comparator: Arm B (Comparator Arm)<br>Placebo in combination with nab-paclitaxel and gemcitabine | Drug: Placebo<br> <br> Drug: Gemcitabine<br> <br> * Other names: Gemzar;Drug: Nab-Paclitaxel<br> <br> * Other names: Abraxane;|
| No Intervention: Observational Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Front-line Pancreatic Cancer, Metastatic Pancreatic Cancer, Gemcitabine, Nab-paclitaxel, Abraxane, Free IGF-1, Heregulin