Phase I/II study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine in patients with advanced pancreatic cancer

• Conditions: Histologically or cytologically confirmed solid cancer of any pathology or adenocarcinoma of the pancreas; MedDRA version: 9.1Level: LLTClassification code 10065147Term: Malignant solid tumor; MedDRA version: 9.1Level: LLTClassification code 10052747Term: Adenocarcinoma pancreas

• Registration Number: EUCTR2007-001609-81-DE
• Lead Sponsor: Philogen S.pA.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-18
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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 <80% for phase II (ECOG performance status =2).
?Patients aged >=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

?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.

Study & Design

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