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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
37
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01493336