NGR018 Phase II Ovarian Cancer Trial
Research type
Research Study
Full title
NGR018 Randomized phase II study of NGR-hTNF plus an anthracycline versus an anthracycline alone in platinum-resistant ovarian cancer.
IRAS ID
102127
Contact name
Rosemary Lord
Sponsor organisation
MolMed S.p.A.
Eudract number
2010-023613-61
Clinicaltrials.gov Identifier
Research summary
This is a multicenter, randomised, 2-arm (1:1 ratio), phase II study with a comparison of NGRhTNF plus an anthracycline (either Pegylated Liposomal Doxorubicin [PLD] or doxorubicin) versus an anthracycline alone (either PLD or doxorubicin) in ovarian cancer patients previously treated with a maximum of two platinum based regimen (cisplatin or carboplatin) plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population). The study will recruit a 100 patients, (50 in each arm) and patients will be 18 years or older. The purpose of the study is to compare the progression-free survival in patients randomised to NGR-hTNF plus an anthracycline versus patients randomised to an anthracycline alone. It will also compare overall survival, response rate, disease control, safety/toxicity profile related to NGR-hTNF. The study will run for approximately 18 months, but the duration will be related to clinical outcome (documented by RECIST criteria). RECIST is an internationally recoginsed criteria for measuring tumour responses using x-rays, CT scans and MRI. In case of response or stable disease, NGR-hTNF and pegylated liposomal doxorubicin will be continued until progressive disease, while doxorubicin will be administered for a maximum of 8 cycles and NGR-hTNF will then be continued as monotherapy until progressive disease.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0424
Date of REC Opinion
3 Aug 2012
REC opinion
Further Information Favourable Opinion