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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01493336
First received: December 14, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This randomized, open-label, two-way crossover study will evaluate the relative bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) ver sus commercial Xeloda tablets in patients with colorectal or breast cancer. Pati ents will be randomized to a sequence of single oral doses of capecitabine RDT o r Xeloda on Days 1 and 2 of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.


Condition Intervention Phase
Breast Cancer, Colorectal Cancer
Drug: capecitabine RTD
Drug: capecitabine [Xeloda]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative bioavailability: Area under the concentration-time curve (AUC) [ Time Frame: Multiple sampling pre-dose to 6 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01493336     History of Changes
Other Study ID Numbers: BP27931, 2011-005185-37
Study First Received: December 14, 2011
Last Updated: November 3, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014