Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the trial is to document the preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGC Biologics S.p.A.; MolMed S.p.A.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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 109/L and platelets > 100 x 109/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) ≥ 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

Exclusion Criteria:

• Patients may not receive any other investigational agents while on study

• Patients with myocardial infarction within the last six (6) 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 tumor, 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 or contraindications 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