Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004061

Trial Description

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Title

A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a Phase I/II study for patients with solid tumors and renal cell carcinoma (RCC; for
the Phase II part). L19-IL2 is a tumor targeted immunocytokine constituted of a single chain
Fragment variable (scFv) format directed against the ED-B domain of fibronectin, one of the
most important markers for neoangiogenesis, and the human cytokine interleukin-2 (IL2).

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Brief Summary in Scientific Language

This is an open-label, non-randomised, multicentre, Phase I/II study to assess safety,
pharmacokinetics (PK), and early signs of activity of L19-IL2 monotherapy.

In the first part of the study, there will be 5 dose escalation steps in sequential cohorts
of patients with advanced solid tumours. In the second part of the study, patients with
advanced RCC will be given a fixed dose of L19IL2 at the RD.

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Organizational Data

  •   DRKS00004061
  •   2013/06/06
  •   2010/01/27
  •   no
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Secondary IDs

  •   2005-002716-16 
  •   NCT01058538  (ClinicalTrials.gov)
  •   PH-L19IL2-01/05  (Philogen S.p.A.)
  •   2005-002716-16 
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Health Condition or Problem studied

  •   Advanced Solid Tumours
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: L19IL2
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- To determine the maximum tolerated dose (MTD) and recommended dose (RD) of the human L19IL2 fusion-cytokine.; time frame: 21 days

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Secondary Outcome

- To determine the pharmacokinetic profile.; time frame: 5 days
- To determine the qualitative and quantitative toxicity profile.; time frame: 21 days
- To assess the presence of anti-fusion protein antibodies in treated patients.; time frame: 18 weeks
- To evaluate the safety profile of repeated administrations of L19IL2 in patients treated at the RD.; time frame: 1 year
- To identify early signs of antitumour activity.; time frame: 1 year

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Countries of Recruitment

  •   Germany
  •   Italy
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Locations of Recruitment

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Recruitment

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  •   2005/11/30
  •   33
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- For the first part of the study: histologically or cytologically confirmed solid
cancer with evidence of advanced disease for which no other standard treatment is
available or appropriate. For the second part of the study: Histologically or
cytologically confirmed advanced RCC.

- Patients must have at least one measurable lesion as detected by computed tomography
(CT).

- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved
to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) (v3.0) Grade </=1.

- Patients who have received autologous marrow/stem cell infusion using monoclonal
antibody-purged specimens are eligible.

- Adult patients of both sexes aged 18 years or older.

- Eastern Cooperative Oncology Group (ECOG) performance status </=2.

- Sufficient haematological, liver and renal function:

- Absolute neutrophil count (ANC) >/=1.5 x 109/L, platelets >/=100 x 109/L, haemoglobin
(Hb) >/=9.0 g/dL,

- Alkaline phosphatase (AP) </=3 x upper limit of the reference range (ULN) and alanine
aminotransferase (ALT) and/or aspartate aminotransferase (AST) </=3 x ULN, and
bilirubin <1.5 x ULN; however, in the presence of liver metastases, AP </=5 x ULN and
ALT and/or AST </=5 x ULN, and bilirubin <1.5 x ULN,

- Creatinine </=ULN, or 24 h creatinine clearance >/=50 mL/min.

- Pulse oximetry >94% on room air.

- Negative serum pregnancy test for females of childbearing potential within 14 days of
starting treatment.

- Life expectancy of at least 3 months.

- Evidence of a personally signed and dated informed consent indicating that the
patient (or legally acceptable representative) has been informed of all pertinent
aspects of the study.

- Willingness and ability to comply with the scheduled visits, treatment plan,
laboratory tests and other study procedures.

- Negative human immunodeficiency virus (HIV) test 2 to 3 weeks before administration
of study treatment (with informed consent for test taken).

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Exclusion Criteria

- Presence of active infections (eg 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.

- Chronic aggressive 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.

- Ischaemic 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 intravenously administered proteins/peptides/antibodies.

- Pregnancy or breast feeding. Female patients must agree to use effective
contraception, or be surgically sterile or postmenopausal. The definition of
effective contraception will be based on the judgement of the principal investigator
or a designated associate.

- Chemotherapy (standard or experimental) within 4 weeks of the administration of study
treatment, or 6 weeks for nitrous ureas, l-phenylalanine mustard (LPAM) or
temozolamide.

- Radiation therapy within 4 weeks of the administration of study treatment.

- 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.

- Prior allografts (including bone marrow or stem cells).

- Patient requires or is taking corticosteroids or other immunosuppressant drugs on a
long term basis. Limited use of corticosteroids to treat or prevent acute
hypersensitivity reactions is not considered an exclusion criterion.

- Investigational study drug taken within 4 weeks of the administration of study
treatment or concurrent treatment with other anti-cancer therapy.

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Addresses

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    • Philogen S.p.A.
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    • European Institute of Oncology Milan (Italy)
    • Filippo De Braud, Dr 
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    • European Institute of Oncology Milan (Italy)
    • Filippo De Braud, Dr 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/11/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.