A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
NCT ID: NCT01493336
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2012-05-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Capecitabine RTD
capecitabine RTD
single oral dose
capecitabine [Xeloda]
standard treatment
Xeloda
capecitabine [Xeloda]
single oral dose
capecitabine [Xeloda]
standard treatment
Interventions
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capecitabine RTD
single oral dose
capecitabine [Xeloda]
single oral dose
capecitabine [Xeloda]
standard treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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2011-005185-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP27931
Identifier Type: -
Identifier Source: org_study_id