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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine RTD
* Drug: capecitabine [Xeloda]
* Drug: capecitabine [Xeloda]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine RTD<br> | Drug: capecitabine RTD<br>* single oral dose<br>Drug: capecitabine [Xeloda]<br>* standard treatment<br>|
| Active Comparator: Xeloda<br> | Drug: capecitabine [Xeloda]<br>* single oral dose<br>Drug: capecitabine [Xeloda]<br>* standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability: Area under the concentration-time curve (AUC) |  | Multiple sampling pre-dose to 6 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 30 days |