A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER - Radioimmunotherapy with 131I-L19SIP in patients with cancer

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-007241-12-GB
• Date of registration: 09/10/2008
• Prospective Registration: No
• Primary sponsor: Philogen S.p.A.
• Public title: A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER - Radioimmunotherapy with 131I-L19SIP in patients with cancer
• Scientific title: A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER - Radioimmunotherapy with 131I-L19SIP in patients with cancer
• Date of first enrolment: 06/10/2008
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007241-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with cancer
2. Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer and colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not to be confirmed by cytology/histology
3. ECOG performance status grade 0 or 1.
4. Age =18 and = 75 yrs
5. Adequate haematological, liver and renal function (haemoglobin = 9 g/dL, absolute neutrophil count (ANC) = 1.50 x 109/L; platelets = 100 x 109/L, bilirubin within UNL; alkaline phosphatase= 2.5 x UNL; ALT, AST = UNL or = 2.5 x UNL in case of liver metastases; albumin = 2.5 g/dL; creatinine = UNL.
6. All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade = 1.
7. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
8. If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
9. Evidence of a personally signed and dated IEC-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.
10. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
11. Life expectancy of at least 3 months.
12. Signed and dated 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Chemotherapy, radiation, hormonotherapy (with the exception of a gradual titration of LHRH agonists) or immunotherapy or participation in any investigational drug study within 4 weeks of study entry (6 weeks in case of prior nitroureas chemotherapy).
2. Prior radiation dose > 30% of bone marrow volume.
3. Presence of cirrhosis or active hepatitis.
4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.
5. Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
6. Recovery from major trauma including surgery within 4 weeks of administration of study treatment.
7. Pregnancy or lactation or unwillingness to use adequate method of birth control.
8. Active infection or incomplete wound healing.
9. Known history of allergy to intravenously administered proteins / peptides / antibodies.
10. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cancer
MedDRA version: 9.1 Level: LLT Classification code 10007050 Term: Cancer

Intervention(s)

Product Name: 131I-L19SIP
Pharmaceutical Form: Concentrate for solution for injection

Product Name: L19SIP
Pharmaceutical Form: Concentrate for solution for injection

Primary Outcome(s)

Primary end point(s): Phase I:

- Measurements of tumor and organ radiation doses of 131I-L19SIP .
- Overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and following cycles (in those patients undergoing the therapeutic study). NCI-CTC Adverse Events scale V3.0

Phase II:

- Objective tumor response, as measured using the modified Response Evaluation Criteria in Solid Tumors (RECIST). Additional functional information will be obtained using PET/CT.

Main Objective: Phase I: - Determination of maximum tolerated dose and recommended dose
Phase II: - Investigation of the antitumor activity at the recommended dose in cancer patients (objective response rate)

Secondary Objective: Phase I: - Evaluation of pharmacokinetic profile of 131I-L19SIP .
Phase II: - Determination of overall safety profile.

Secondary ID(s)

PH-L19SIPI131-07/07