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: P
Conditions
Interventions
Product Name: Nanoliposomal Irinotecan
Product Code: MM-398
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Irinotecan Hydrochloride
CAS Number: 136572-09-3
Other descr
Sponsors
Merrimack Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival following treatment with MM-398, with orwithout 5-fluorouracil and leucovorin,versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine based therapy.;Secondary Objective: • To compare the following time-to-event efficacy endpoints between the two treatment arms: Progression-free survival (PFS) Time to treatment failure (TTF) • To compare the Objective Response Rate (ORR) between the two treatment arms • To compare the tumor marker response of CA 19-9 between the two treatment arms • To compare the Clinical Benefit Response (CBR) rate between the two treatment arms • To assess patient-reported outcomes (PROs) between the two treatment arms using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life core questionnaire (EORTC-QLQ-C30) • To compare the safety and adverse event profile between the two treatment arms •To determine the pharmacokinetic properties of MM-398, as a single agent and in combination with 5-FU and leucovorin, in this population;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: The analysis for primary endpoint will take place once at least 305 death events have occurred. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival Time to treatment failure Objective Response Rate Clinical Benefit Response Tumor Marker Response Patient Reported Outcome;Timepoint(s) of evaluation of this end point: On-going | — |
Countries
Argentina, Australia, Brazil, Canada, Czech Republic, France, Germany, Hungary, India, Italy, Korea, Republic of, Russian Federation, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactMerrimack 398 clinical trial Mger
Merrimack Pharmaceuticals Inc
Outcome results
None listed