NAPOLI-1 Study Design

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This is an open label, randomized, three arm, Phase 3 trial of MM-398, with or without 5-FU and leucovorin, versus 5-fluorouracil (5-FU) and leucovorin (also known as folinic acid), in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

Approximately 405 eligible patients will be enrolled in this global study.  All patients will participate in up to 28 days of screening, during which they will be assessed for eligibility and screened for the UGT1A1*28 allele.  Eligible patients will be randomized, in a 1:1:1 ratio, to one of the following treatment arms:

  • Arm A (experimental arm): MM-398

  • Arm B (control arm): 5-FU and leucovorin  

  • Arm C (experimental arm): MM-398, 5-FU and leucovorin

Patients will be evenly randomized to the treatment arms using an Interactive Web Response System (IWRS) at a central location.  The randomization will be stratified based on the following prognostic factors:

  • Baseline albumin levels (>4.0 g/dL vs < 4.0 g/dL)

  • KPS (70 and 80 vs > 90)

  • Ethnicity (Caucasian vs East Asian vs All Others)

 

studydesign flowchart 2.JPG

 

 

* Patients who are homozygous for UGT1A1*28 allele and are randomized to Arm A, will receive the first cycle of therapy at a reduced dose of 80 mg/m2.  If the patient does not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose may be increased in increments of 20 mg/m2, up to a maximum of 120 mg/m2.

** Patients who are homozygous for UGT1A1*28 allele and are randomized to Arm C, will receive the first cycle of therapy at a reduced dose of 60 mg/m2.  If the patient does not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose may be increased to 80 mg/m2.

Related Content

ClinicalTrials.gov Pancreatic Cancer Action Network MM-398 Pancreatic Cancer