Patients with Inoperable, Locally Advanced or Metastatic Pancreatic Cancer, not previously treated with chemotherapy for the current disease
Conditions
Interventions
Product Name: LipoplatinTM
Pharmaceutical Form: Solution for infusion
Sponsors
Regulon AE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female > 18 years of age; histologically or cytologically confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma; at least one measurable lesion; no prior chemotherapy/ radiotherapy/other investigational drug treatment for pancreatic cancer; performance status 0-2; life expectancy >3 months; adequate haematologic/hepatic/renal/cardiac function; signed informed consent. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: o Other malignancy within the past 5 years, except malignancies with <5% probability of recurrence, curatively treated squamous or basal cell skin carcinoma, or in situ carcinoma of the cervix. o Known allergy to any of the study drug components. o Prior chemotherapy, radiotherapy or investigational drug treatment for pancreatic cancer. o Known brain metastases. o Recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias. o Known Hepatitis B or C, or AIDS. o Known underlying immune deficiency or history of autoimmune diseases (e.g. autoimmune neutropenia, hemolytic anaemia or thrombocytopenia, systemic lupus erythematosus, Sjögren syndrome, Addison’s disease, scleroderma, myasthenia Gravis, Goodpasture’s syndrome). o Pregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement. o Any medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia). o Patients for whom compliance with the protocol is doubtful
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the activity and safety between the two arms of treatment. Primary endpoint: • To compare the one year survival and overall survival (OS) ;Secondary Objective: To compare progression-free survival time (PFS). To compare objective response rate (ORR) To compare quality of life (Q?L) To compare safety ;Primary end point(s): one year survival and overall survival (OS) ;Timepoint(s) of evaluation of this end point: 1year after the enrollment of the 100th patient or when 180 patients complete 6 cycles of treatment (interim analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): progression-free survival time (PFS). objective response rate (ORR) quality of life (Q?L) safety;Timepoint(s) of evaluation of this end point: 1year after the enrollment of the 100th patient or when 180 patients complete 6 cycles of treatment (interim analysis) | — |
Countries
China, France, Germany, Greece, Israel, Italy, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public Contacthttp://clintest.org/admin/support
Regulon AE
Outcome results
None listed