NGR016 phase II study in patients with advanced soft tissue sarcoma
Research type
Research Study
Full title
NGR016: Randomised phase II study evaluating two doses of NGR-hTNF administered either as single agent or in combination with doxorubicin in patients with advanced soft tissue sarcoma (STS).
IRAS ID
79061
Contact name
Michael Gordon Leahy
Sponsor organisation
Molmed
Eudract number
2010-018851-88
Clinicaltrials.gov Identifier
Research summary
The aim of this study is to evaluate two doses of NGR-hTNF administered either on its own or in combination with doxorubicin in patients with local or advanced Soft Tissue Sarcoma (STS), untreated or previously treated with one or more prior systemic regimen. The study will recruit 96 patients over a 2 year period. Patients will be 18 years and over, with a proven history of locally advanced or metastic Soft Tissue Sarcoma, excluding extra bone Ewing Sarcoma. They will not be amenable to surgery, radiotherapy or combined modality therapy with curative intent.The purpose of this study is to evaluate the period free from disease growth or spread and the safety profile of two NGR-hTNF doses given either as single agent or in combination with doxorubicin. It also sets the objective of evaluating the response of disease to treatment, the duration of the response and the overall survival.The duration of study treatment will be related to the response of the disease to the study treatment based on RECIST criteria. RECIST is an internationally recognised criteria for measuring tumour responses using X-ray, CT scan and MRI. If the disease responds to the treatment or remain stable, on the basis of the patients medical condition, side effects, and patient and doctors decision to continue, NGR-hTNF treatment will continue weekly from that point. The study will run for two and a half years.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/NW/0672
Date of REC Opinion
1 Nov 2011
REC opinion
Further Information Favourable Opinion