Histologically or cytologically confirmed solid cancer of any pathology or adenocarcinoma of the pancreas MedDRA version: 9.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor MedDRA version: 9.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas
Conditions
Interventions
Product Name: L19 Interleukin-2
Product Code: L19IL2
Pharmaceutical Form: Solution for infusion
Trade Name: Gemzar®
Pharmaceutical Form: Powder for injection*
Sponsors
Philogen S.pA.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Histologically or cytologically confirmed solid cancer of any pathology or adenocarcinoma of the pancreas with evidence of locally advanced (non resectable Stage II or III) or metastatic disease (Stage IV; Appendix B). ?Karnofsky performance status 60-100% for phase 1 and >50 and =18 years. ?Sufficient hematologic, liver and renal function: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ?Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. ?Presence of known brain metastases. ?Known to have a second uncontrolled cancer of other primary origin within the last 5 years. ?Chronic active hepatitis or active autoimmune diseases. ?History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. ?Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria). ?Irreversible cardiac arrhythmias requiring permanent medication. ?Uncontrolled hypertension. ?Ischemic peripheral vascular disease (Grade IIb-IV). ?Severe rheumatoid arthritis. ?Severe diabetic retinopathy. ?Recovery from major trauma including surgery within 4 weeks of administration of study treatment. ?Known history of allergy to IL2, gemcitabine, or other intravenously administered human proteins/peptides/antibodies. ?Chemotherapy (standard or experimental) or radiation therapy within 4 weeks of the administration of study treatment for patients recruited to the phase I part of the study. ?Prior chemotherapy or radiation therapy or treatment with an investigational study drug for patients recruited to the fixed-dose part (phase II) of the study. ?Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment. ?Growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part: - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of human L19IL2 in combination with gemcitabine in advanced solid tumour patients for whom gemcitabine is a suitable therapy according to the discretion of the principal investigator or in relapsed/refractory advanced pancreatic cancer patients after 1st line gemcitabine-containing therapy. Phase II part: - To investigate the anti-cancer activity of L19IL2 in combination with gemcitabine as measured by Clinical Benefit Response in chemotherapy-naïve patients with advanced pancreatic cancer. ;Secondary Objective: Phase I part: - To investigate the pharmacokinetic properties of L19IL2 and gemcitabine when given in combination. - To investigate induction of human anti-fusion protein antibody (HAFA) levels. - To investigate early signs of anti-tumor activity of L19IL2 combined with gemcitabine in terms of objective response rate, median overall survival and survival at 12 months. Phase II part: - To investigate safety and tolerability of the combination treatment of L19IL2 and gemcitabine. - To assess the presence of anti-fusion protein antibodies in treated patients. - To investigate the objective response rate, median progression-free survival, and median overall survival of L19IL2 in combination with gemcitabine. ;Primary end point(s): To determine the maximum tolerated dose (MTD) and recommended dose (RD) of human L19IL2 in combination with gemcitabine in advanced solid tumour patients for whom gemcitabine is a suitable therapy according to the discretion of the principal investigator or in relapsed/refractory advanced pancreatic cancer patients after 1st line gemcitabine-containing therapy. | — |
Countries
Germany
Outcome results
None listed