A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT02399137
- Lead Sponsor
- Merrimack Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (Experimental Arm) Nab-Paclitaxel MM-141 in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Placebo Placebo in combination with nab-paclitaxel and gemcitabine Arm A (Experimental Arm) MM-141 MM-141 in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Gemcitabine Placebo in combination with nab-paclitaxel and gemcitabine Arm B (Comparator Arm) Nab-Paclitaxel Placebo in combination with nab-paclitaxel and gemcitabine Arm A (Experimental Arm) Gemcitabine MM-141 in combination with nab-paclitaxel and gemcitabine
- Primary Outcome Measures
Name Time Method Progression Free Survival Approximately 2 years
- Secondary Outcome Measures
Name Time Method 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 Objective Response Rate according to RECIST v1.1 Approximately 2 years Overall Survival Approximately 2.5 years
Trial Locations
- Locations (65)
Banner MD Anderson Cancer Ctr.
🇺🇸Gilbert, Arizona, United States
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Cancer Care Assoc Med Grp
🇺🇸Redondo Beach, California, United States
UCSF Cancer Center
🇺🇸San Francisco, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Central Coast Med Onc Corp
🇺🇸Santa Maria, California, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Baptist Health Med Gr Onc, LLC
🇺🇸Miami, Florida, United States
Scroll for more (55 remaining)Banner MD Anderson Cancer Ctr.🇺🇸Gilbert, Arizona, United States