Synta 9090-08
Research type
Research Study
Full title
A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination with Docetaxel Versus Docetaxel Alone in Subjects with Stage IIIb or IV Non-Small-Cell Lung Cancer
IRAS ID
77756
Sponsor organisation
Synta Pharmaceuticals Corp.
Eudract number
2011-001084-42
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn about the safety and Effectiveness of ganetespib, an experimental drug for the treatment of advanced lung cancer. The first stage will investigate the clinical activity of the combination of ganetespib and docetaxel.The second stage will evaluate the Effectiveness of the combination of anetespib and docetaxel.patients will be randomly assigned to receive either ganetespib and docetaxel (a drug already licensed for treatment of advanced lung cancer) or docetaxel alone.patients will receive multiple 3 week cycles of treatment until disease progression or unacceptable toxicity occurs.Tumour assessments will be performed every 6 weeks until disease progression and patients will be followed formsurvival at approximately 6 week intervals from their last dose, until death or patient can no longer be contacted.The aim of the study is to compare the progression free survival and overall survival in patients who received the combination of ganetespib and docetaxel against those who received docetaxel alone.
REC name
West of Scotland REC 1
REC reference
11/AL/0393
Date of REC Opinion
2 Aug 2011
REC opinion
Further Information Favourable Opinion