A study of MM-398 with or without 5-Fluorouracil and Leucovorin compared with 5- Fluorouracil and Leucovorin in Patients with advanced pancreatic cancer who were previously treated unsuccessfully with a gemcitabine-based therapy.

Phase 1

• Conditions: Metastatic Pancreatic Cancer; MedDRA version: 14.1 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004687-30-GB
• Lead Sponsor: Merrimack Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 405

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of
exocrine pancreas
• Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines
• Documented disease progression after prior gemcitabine or
gemcitabine containing therapy, in locally advanced or metastatic
setting. Examples of permitted therapies include, but are not limited to:
o Single agent gemcitabine
o Any one gemcitabine-based regimen, with or without
maintenance gemcitabine
o Single agent gemcitabine to which a platinum agent, a
fluoropyrimidine, or erlotinib was subsequently added
o Gemcitabine administered in the adjuvant setting if disease
recurrence occurred within 6 months of completing the
adjuvant therapy
• KPS > 70
• Adequate bone marrow reserves as evidenced by:
o ANC > 1,500 cells/µl without the use of hematopoietic growth
factors; and
o Platelet count > 100,000 cells/µl; and
o Hemoglobin > 9 g/dL
• Adequate hepatic function as evidenced by:
o Serum total bilirubin within normal range for the institution
(biliary drainage is allowed for biliary obstruction)
o Albumin levels = 3.0 g/dL
o Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN is acceptable
if liver metastases are present)
• Adequate renal function as evidenced by a serum creatinine =1.5
x ULN
• Normal ECG or ECG without any clinically significant findings
• Recovered from the effects of any prior surgery, radiotherapy or
other anti-neoplastic therapy
• At least 18 years of age
• Able to understand and sign an informed consent (or have a legal
representative who is able to do so)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 255

Exclusion Criteria

• Active CNS metastases (indicated by clinical symptoms, cerebral
edema, steroid requirement, or progressive disease) patients should have been off steroids for at least 28 days prior to starting study therapy
• Clinically significant gastrointestinal disorder including hepatic
disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
• 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.
• Severe arterial thromboembolic events (myocardial infarction,
unstable angina pectoris, stroke) less than 6 months before inclusion
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
• 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
• Known hypersensitivity to any of the components of MM-398, other liposomal products, fluropyrimidines or leucovorin
• 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
• 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
• 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 ofreproductive 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified