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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • New Zealand
      • Christchurch, New Zealand, 8011
      • Grafton, New Zealand, 1010
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, WC1E 6AU
      • Newcastle upon Tyne, United Kingdom, NE7 7DN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capecitabine RTD
Drug: capecitabine RTD
single oral dose
Drug: capecitabine [Xeloda]
single oral dose
Drug: capecitabine [Xeloda]
standard treatment
ACTIVE_COMPARATOR: Xeloda
Drug: capecitabine [Xeloda]
single oral dose
Drug: capecitabine [Xeloda]
standard treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (ESTIMATE)

December 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP27931
  • 2011-005185-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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