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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merrimack Pharmaceuticals
- Enrollment
- 88
- Locations
- 65
- Primary Endpoint
- Progression Free Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
Intervention: MM-141 (Drug)
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
Intervention: Gemcitabine (Drug)
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
Intervention: Nab-Paclitaxel (Drug)
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
Intervention: Placebo (Drug)
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
Intervention: Gemcitabine (Drug)
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
Intervention: Nab-Paclitaxel (Drug)
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: Approximately 2 years
Secondary Outcomes
- 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)