Phase III, ABI-007 vs Dacarbazine Metastatic Malignant Melanoma
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients with Metastatic Malignant Melanoma
IRAS ID
20927
Eudract number
2007-004097-32
Clinicaltrials.gov Identifier
Research summary
Melanoma is rapidly increasing in incidence. Very few therapies are approved for stage IV melanoma. The main objective for this study is to compare ABI-007 with Dacarbazine with respect to antitumour activity in patients who are previously untreated with cytotoxic chemotherapy for metastatic malignant melanoma (stage IV). Patients will be entered into one of two treatment groups. Patients will receive either ABI-007 weekly for three weeks followed by one week of rest or Dacarbazine once every 21 days. Patients may stay on the study until their disease has become worse, they develop an unacceptable side effect, are no longer able to participate, or decide they no longer want to continue in the study.The trial will be completed in USA, Canada, Australia and Western Europe and it is planned that 257 patients will enter each treatment group.There will also be an optional sub-study. Tissue and blood samples will be analysed to have better understanding of melanoma tumours, develop new tests to improve predictions of which treatments will help which people, and learn about changes in the status of melanoma patients during their treatment. The study has closed following successful recruitment
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
09/H1211/68
Date of REC Opinion
30 Jul 2009
REC opinion
Further Information Favourable Opinion