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

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ClinicalTrials.gov Identifier: NCT01493336
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer, Colorectal Cancer Drug: capecitabine RTD Drug: capecitabine [Xeloda] Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Capecitabine RTD Drug: capecitabine RTD
single oral dose
Drug: capecitabine [Xeloda]
standard treatment
Active Comparator: Xeloda Drug: capecitabine [Xeloda]
single oral dose
Drug: capecitabine [Xeloda]
standard treatment


Outcome Measures

Primary Outcome Measures :
  1. Relative bioavailability: Area under the concentration-time curve (AUC) [ Time Frame: Multiple sampling pre-dose to 6 hours post-dose ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493336


Locations
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, 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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01493336     History of Changes
Other Study ID Numbers: BP27931
2011-005185-37 ( EudraCT Number )
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents