Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Front-line Pancreatic Cancer, Metastatic Pancreatic Cancer, Gemcitabine, Nab-paclitaxel, Abraxane, Free IGF-1, Heregulin
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.
Interventions
Sponsors
Merrimack Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | Approximately 2 years |
Secondary
| Measure | 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 |
Countries
Canada, Germany, Poland, Spain, United Kingdom, United States
Outcome results
None listed