A Study of MM-398 compared with 5-fluorouracil abd Leucovorin in Patients with advanced pancreatic cancer.

Conditions: Metastatic pancreatic cancer.
MedDRA version: 14.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004687-30-IT

Lead Sponsor: MERRIMACK PHARMACEUTICALS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

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.
(for complete list see the protocol).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

• Prior irinotecan treatment
• Active CNS metastases (indicated by clinical symptoms, cerebral
edema, steroid requirement, or progressive disease)
• 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.
• Major surgery or radiotherapy within 4 weeks of enrollment
• Severe arterial thromboembolic events (myocardial infarction,
unstable angina pectoris, stroke) less than 6 months before inclusion.