Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overPharmaceutical / IndustryMM-398-07-03-01

Trial Description


The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
  • Metastatic disease
  • Documented disease progression after prior gemcitabine based therapy
  • KPS >/= 70
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function

Exclusion Criteria:

  • Active CNS metastasis
  • Clinically significant GI disorders
  • Severe arterial thromboembolic events less than 6 months before inclusion
  • NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
  • Active infection or uncontrolled fever
  • Pregnant or breast feeding patients

Trial Contact Information

Trial Lead Organizations/Sponsors

Merrimack Pharmaceuticals, Incorporated

    Eliel Bayever, MD, Study Director

    Link to the current record.
    NLM Identifier NCT01494506 processed this data on April 09, 2015

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to