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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overPharmaceutical / IndustryMM-398-07-03-01
NCT01494506

Trial Description

Summary

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, MDStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01494506
ClinicalTrials.gov processed this data on November 12, 2014

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

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