Spots Global Cancer Trial Database for A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
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Trial Identification
Brief Title: A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
Official 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
Study ID: NCT01493336
Conditions
Study Description
Brief Summary: This randomized, open-label, two-way crossover study will evaluate the relative bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2 of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Adelaide, South Australia, Australia
, Nedlands, Western Australia, Australia
, Christchurch, , New Zealand
, Grafton, , New Zealand
, Glasgow, , United Kingdom
, Leeds, , United Kingdom
, London, , United Kingdom
, Newcastle upon Tyne, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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