Status:
COMPLETED
Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will ...
Detailed Description
This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned. Patients, with advanced or ...
Eligibility Criteria
Inclusion
- Patients ≥18 years old with proven advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and previously treated with a non cumulative dose of anthracyclines (\<300 mg/sqm) or chemotherapy naïve.
- Life expectancy more than 3 months.
- ECOG performance status 0 - 2.
- Normal cardiac function (left ventricular ejection fraction \[LVEF\] ≥55%) and absence of uncontrolled hypertension.
- Absence of any conditions involving hypervolemia and its consequences.
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Neutrophils \> 1.5 x 10\^9/L and platelets \>100 x 10\^9/L Bilirubin \< 1.5 x ULN AST and/or ALT \< 2 x ULN Serum creatinine \< 1.5 x ULN
- Patients may have had prior therapy providing the following conditions are met:
- Chemo, radio, hormonal, immuno or anti-vascular therapy: wash-out period of 28 days.
- Surgery: wash-out period of 14 days.
- Patients must give written informed consent to participate in the study.
Exclusion
- Concurrent anticancer therapy
- Patients must not receive any other investigational agents while on study
- Patients with a LVEF \<55%
- New York Heart Association class III or IV cardiac disease
- Acute angina
- Patients with myocardial infarction within the last six (6) months
- Patient with significant peripheral vascular disease
- Thrombosis of main portal vein
- Previous signs of severe toxicity doxorubicin related
- Previous signs of cardiotoxicity doxorubicin related
- Patients previously treated with a cumulative dosage of anthracyclines ≥300 mg/m\^2
- Clinical signs of CNS involvement
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Key Trial Info
Start Date :
February 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00305084
Start Date
February 28 2006
End Date
May 8 2007
Last Update
October 4 2019
Active Locations (4)
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1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
2
Azienda Ospedaliera Universitaria "San Martino"
Genova, Italy, 16132
3
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
4
University Medical Centre, Nijmegen
Nijmegen, Netherlands