Trial record 1 of 1 for:    NCT01494506
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Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer (NAPOLI 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01494506
First received: December 14, 2011
Last updated: September 4, 2013
Last verified: September 2013

December 14, 2011
September 4, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01494506 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer
A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
  • Drug: MM-398

    Arm A: MM-398 120 mg/m2 IV Q3W

    Arm C: MM-398 80mg/m2 IV Q2W

    Other Name: PEP02
  • Drug: 5 Fluorouracil

    Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

    Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks

    Other Name: 5-FU
  • Drug: Leucovorin

    Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks

    Arm C: Leucovorin 400 mg/m2 IV every 2 weeks

    Other Name: Folinic Acid
  • Experimental: MM-398
    MM-398 Q3W IV
    Intervention: Drug: MM-398
  • Active Comparator: 5 Fluorouracil and Leucovorin IV
    5 Fluorouracil and Leucovorin IV
    Interventions:
    • Drug: 5 Fluorouracil
    • Drug: Leucovorin
  • Experimental: MM-398, 5-FU and Leucovorin
    MM-398, 5-FU and Leucovorin Q2W IV
    Interventions:
    • Drug: MM-398
    • Drug: 5 Fluorouracil
    • Drug: Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
405
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   South Africa,   Spain,   Taiwan,   United Kingdom
 
NCT01494506
MM-398-07-03-01
Yes
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Not Provided
Merrimack Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP