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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01493336

Enrollment

Registered

2011-12-15

Start date

2012-05-31

Completion date

2012-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer

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.

Interventions

DRUGcapecitabine RTD

single oral dose

DRUGcapecitabine [Xeloda]

single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety: Incidence of adverse events	30 days

Countries

Australia, New Zealand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026