Bioavailability Study of Capecitabine in Adult Solid Tumour Patients

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Single Dose, Two-way Cross-Over Study to Investigate the Relative Bioavailability of Capecitabine in Rapid Disintegrating Tablets (RDT) Versus the Commercial Xeloda® Tablets Following Oral Administrations in Adult Patients with Solid Tumours

• IRAS ID

  92927

• Contact name

  Christopher Twelves

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2011-005185-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Xeloda© (commercial capecitabine) is a drug that is marketed by F. Hoffmann-La Roche Ltd as an anticancer agent which works by stopping cancer cells from growing and shrinking the tumour. Commercial capecitabine is currently available as a film-coated tablet and is taken orally (by mouth). Roche is developing a new formulation for children that can be dispersed in water (Rapid Disintegrating Tablet ?? RDT) which will make it easier to administer. The primary aim of the study is to determine whether the new capecitabine rapid disintegrating tablet (RDT) is absorbed and distributed by the body in the same way as the commercial capecitabine tablet formulation. The study will also help determine whether the capecitabine rapid disintegrating tablet (RDT) is safe and any side effects which may be associated with it. Patients will be randomised to receive a single morning dose of 2000 mg capecitabine RDT (test formulation) on Day 1, and a single morning dose of 2000 mg commercial capecitabine (reference formulation) on Day 2 (Cohort A), or vice versa (Cohort B). The study will enrol patients for about 6 months but each patient will only be involved for up to 58 days (including screening and follow-up). This is an outpatient study and each patient will be asked to visit the clinic up to 5 times.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0007

• Date of REC Opinion

  3 Feb 2012

• REC opinion

  Further Information Favourable Opinion