A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer
Part A is an open-label, multiple ascending dose patient study of M402 given first as a
single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen.
It will be conducted to evaluate the safety and tolerability of M402 alone and in
combination with nab-paclitaxel and gemcitabine and to recommend an M402 dose regimen for
subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating
the antitumor activity of M402 in combination with nab-paclitaxel and gemcitabine compared
with nab-paclitaxel, gemcitabine, and placebo. In both Parts A and B, a treatment period
consists of one 28-day cycle. The Study Patient and Investigator can decide to continue with
additional 28-day cycles according to the patient's status at the end of each 28-day cycle.
Only Part A is currently open.
Part A - Primary Objectives:
- To evaluate the safety and tolerability of M402 in combination with nab-paclitaxel and
- To determine the dose of M402 to be carried forward into Part B.
Part B - Primary Objective:
To evaluate overall survival in patients treated with M402 + nab-paclitaxel + gemcitabine
compared with placebo + nab-paclitaxel + gemcitabine.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Part A: Safety
At baseline and then each of 6 visits after the start of dosing in a 28-day treatment cycle, adverse event surveillance, liver function enzyme levels, WBC with differential, ANC, aPTT, and PT are measured. This is repeated for each 28 day treatment cycle until disease progression or end of treatment. A final assessment is performed 30 days post-final M402 dose.
Part A: Baseline to 28 days after first-dose and end of study
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Gabrail Cancer Center||Canton, Ohio 44718|
|University of Texas Health Sciences Center||San Antonio, Texas|
|Institute of Translational Oncology Research||Greenville, South Carolina 29605|