Study of XL184 in Subjects with Advanced Solid Tumours
Research type
Research Study
Full title
A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors
IRAS ID
72973
Sponsor organisation
Exelixis, Inc.
Eudract number
2009-012964-14
Clinicaltrials.gov Identifier
Research summary
A Phase 2 Randomised Discontinuation Study of XL184 in Patients with Advanced Solid TumoursThis Phase 2 study is being conducted to evaluate the efficacy and safety of XL184 in patients with 9 selected advanced tumour types. In the UK, only the Non-Randomised Expansion (NRE) section of the protocol will be performed, for 2 cohorts of cancer type: CRPC (Castration-Resistant Prostate Cancer) Cohort and Non-CRPC Cohort (Ovarian Cancer).Ovarian cancer is the fifth most common cancer in females in the UK and the fourth most common cause of cancer death in women in the UK. Prostate cancer is the most common cancer in men in the UK, and is the second most common cause of cancer death in UK men, after lung cancer.XL184 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTK) with growth promoting and angiogenic properties.The study will be conducted at approximately 45 sites globally in the US, Europe and Asia-Pacific and approximately 1300 patients are planned to participate. The study will be performed by suitably qualified doctors at NHS hospitals across the UK. This study will last for approximately 6 months for patients with at least a Partial Response and approximately 3 months for patients with Disease Progression. Early stopping of the NRE cohorts for efficacy or futility is not planned.General health and research related blood tests, urine tests, ECGs, questionnaires and scans will be performed in order to assess the participants?? health and the efficacy of the study drug. Tumour assessments will be performed regularly until objective tumour progression.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
11/LO/0398
Date of REC Opinion
24 Jun 2011
REC opinion
Further Information Favourable Opinion