The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
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
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Study type
Description of intervention(s) / exposure
Treatment: Drugs - capecitabine RTD
Treatment: Drugs - capecitabine [Xeloda]
Treatment: Drugs - capecitabine [Xeloda]

Experimental: Capecitabine RTD -

Active Comparator: Xeloda -

Treatment: Drugs: capecitabine RTD
single oral dose

Treatment: Drugs: capecitabine [Xeloda]
single oral dose

Treatment: Drugs: capecitabine [Xeloda]
standard treatment

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Relative bioavailability: Area under the concentration-time curve (AUC)
Timepoint [1] 0 0
Multiple sampling pre-dose to 6 hours post-dose
Secondary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
30 days

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Country [2] 0 0
New Zealand
State/province [2] 0 0
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Hoffmann-La Roche

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications