OSI-906 in Locally Advanced or Metastatic Adrenocortical Carcinoma
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma.
IRAS ID
27550
Contact name
Martin Gore
Sponsor organisation
OSI Pharmaceuticals, Inc
Eudract number
2009-012820-97
Clinicaltrials.gov Identifier
Research summary
The purpose of the research study OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma is to assess safety and efficacy in patients who have previously received 1-2 other drug treatments. Adrenocortical carcinoma is a rare but aggressive cancer with limited treatment options. OSI-906 is a tablet to be taken twice daily with food and water. Approximately 135 participants will be randomly selected to one of two treatment groups, OSI-906 or placebo in a 2:1 ratio. Potential participants would have failed at least one but not more than two prior drug treatments including mitotane. To be eligible to take part participants will be over 18 years of age and unsuitable candidates for further surgical treatment. The study is due to last for up to 4 years and will require regular physical exams, CT scans, ECG, blood and urine tests and completion of a questionnaire. At the end of the study all participants who are responding to the treatment will be given the opportunity to continue taking OSI-906 including those randomised to the placebo arm.
REC name
London - Harrow Research Ethics Committee
REC reference
09/H0714/60
Date of REC Opinion
29 Dec 2009
REC opinion
Further Information Favourable Opinion