9090-14: A Study of Ganetespib in advanced lung cancer
Research type
Research Study
Full title
A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
IRAS ID
122381
Contact name
Dean Fennell
Contact email
Sponsor organisation
Synta Pharmaceuticals Corp.
Eudract number
2012-004349-34
Research summary
Conventional Chemotherapy has largely reached a plateau of effectiveness in improving survival among Non-Small Cell Lund Cancer Patients. Therefore new treatment options are currently being sought.
This is a phase 3 study looking to evaluate whether Ganetespib in combination with Docetaxel, a chemotherapy approved for use in lung cancer, is more effective than Docexal alone. it is hoped that giving Ganetespib together with Docetaxel will increase the treatment effect on cancer by slowing or stopping cancer from growing. However, this has not yet been proven.
The study will enrol about 500 advanced lung cancer patients at about 120 study sites in United States,Canada, and Europe. The amount of time participants will spend in this study can be as much as several yaers, and will depend on how well the study drug(s) is tolerated and whether the disease progresses.
Ganetespib will be administered on Day 1 and Day 15 of each of each 21day treatment cycle. Docetaxal will be administered on Day 1 of each 21 day treatment cycle. The treatment cycles will begin within 4 weeks of receiving satisfactory screening tests and will continue until progressive disease or until unacceptable toxicity occurs. Following withdrawal from the study participants will be following by their study doctor or nurse every 6 weeks by phone call or attendance to clinic for updates on how they are doing.REC name
London - Bloomsbury Research Ethics Committee
REC reference
13/LO/0326
Date of REC Opinion
24 May 2013
REC opinion
Further Information Favourable Opinion