Randomized study of NGR-hTNF given alone or in combination with doxorubicin in sarcoma patients
- Conditions
- ocally advanced or metastatic Soft-tissue sarcoma in patients untreated or previously treated with one or more prior systemicregimen.MedDRA version: 14.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-018851-88-GB
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 69
- Patients >=18 years
- Histologically-proven, locally advanced, or metastatic STS (excluding extraosseus Ewing sarcoma)
- Patients not amenable to surgery, radiotherapy, or combined-modality therapy with curative intent
- Patients untreated or previously treated with one or more systemic regimen
- ECOG Performance status 0-2 (Appendix A)
- At least one untreated (not previously irradiated) target lesion that could be measured in one dimension, according to RECIST criteria
- A life expectancy of 12 weeks or more
- 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 < 2.5 x ULN in absence of liver metastasis or < 5 x ULN in presence of liver metastasis;
Serum creatinine < 1.5 x ULN;
Creatinine clearance (estimated according to Cockcroft-Gault formula, Appendix A) >= 50 ml/min
- Patients may have had prior treatment providing the following conditions are met before treatment start:
Surgery and radiation therapy: wash-out period of 14 days; Systemic therapy: wash-out period of 21 days
- Patients must give written 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
- Patients may not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- LVEF < 55% (only for patients candidate for doxorubicin treatment)
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired) > 450 ms
- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumour, any brain metastasis, seizure not controlled with standard medical therapy) or history of stroke
- 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 childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method