Exclusion Criteria

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Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria:

  1. Active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease); patient should have been off steroids for at least 28 days prior to starting study therapy

  2. Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1

  3. History of any second malignancy in the last 5 years; subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible.  Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years.

  4. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion

  5. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure

  6. Active infection or  an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome

  7. Known hypersensitivity to any of the components of MM-398, other liposomal products, fluropyrimidines or leucovorin

  8. Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study

  9. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

  10. Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test. Both male and female patients of reproductive potential must agree to use a reliable method of birth control, during the study and for 3 months following the last dose of study drug.

Related Content

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