Randomised, Multicenter Phase III Clinical Study of Lipoplatin plus Gemcitabine Versus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer

Phase 1

• Conditions: Patients with Inoperable, Locally Advanced or Metastatic Pancreatic Cancer, not previously treated with chemotherapy for the current disease; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003601-25-GR
• Lead Sponsor: Regulon AE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 328

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

oOther 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.
oKnown allergy to any of the study drug components.
oPrior chemotherapy, radiotherapy or investigational drug treatment for pancreatic cancer.
oKnown brain metastases.
oRecent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias.
oKnown Hepatitis B or C, or AIDS.
oKnown 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).
oPregnant 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.
oAny medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia).
oPatients for whom compliance with the protocol is doubtful

Study & Design

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