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 ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01493336




Registration number
NCT01493336
Ethics application status
Date submitted
14/12/2011
Date registered
15/12/2011
Date last updated
2/11/2016

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
2011-005185-37
Secondary ID [2] 0 0
BP27931
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)

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
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
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Glasgow
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Leeds
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT01493336
Trial related presentations / publications
Public notes

Contacts
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