A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01493336
• Date of registration: 14/12/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
• Scientific 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
• Date of first enrolment: May 2012
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01493336
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Australia, New Zealand, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients,>/= 18 years of age

- Histological/cytological confirmation of colorectal or breast cancer

- Patient is ambulatory and has a Karnofsky performance status of > 70%

- Body surface area between 1.5 and 2.0 m2

- Either:

- Due to receive Xeloda as monotherapy or as combination therapy as per their treating
physician's treatment plan, or

- Currently receiving Xeloda monotherapy and in the investigator's opinion able to
tolerate study drug dose on Day 1 and Day 2

Exclusion Criteria:

- Any contraindication to Xeloda

- Received Xeloda in the 6 days prior to Day 1

- Subjects with organ allografts (other than autologous bone marrow transplant after
high dose chemotherapy)

- Renal impairment

- Pregnant or lactating females

- Participation in an investigational drug study within 28 days prior to screening

- Lack of physical integrity of the upper gastrointestinal tract, or clinically
significant malabsorption syndrome

- Serious uncontrolled intercurrent infections

- History of clinically significant coronary artery disease

- Concomitant treatment with warfarin

- Known dihydropyrimidine dehydrogenase deficiency



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer, Colorectal Cancer

Intervention(s)

Drug: capecitabine [Xeloda]

Drug: capecitabine RTD

Primary Outcome(s)

Relative bioavailability: Area under the concentration-time curve (AUC) [Time Frame: Multiple sampling pre-dose to 6 hours post-dose]

Secondary Outcome(s)

Safety: Incidence of adverse events [Time Frame: 30 days]

Secondary ID(s)

2011-005185-37

BP27931

Source(s) of Monetary Support

Please refer to primary and secondary sponsors