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: August 4, 2014
Last verified: August 2014

December 14, 2011
August 4, 2014
May 2012
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01493336 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer, Colorectal Cancer
  • Drug: capecitabine RTD
    single oral dose
  • Drug: capecitabine [Xeloda]
    single oral dose
  • Drug: capecitabine [Xeloda]
    standard treatment
  • Experimental: Capecitabine RTD
    Interventions:
    • Drug: capecitabine RTD
    • Drug: capecitabine [Xeloda]
  • Active Comparator: Xeloda
    Interventions:
    • Drug: capecitabine [Xeloda]
    • Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand,   United Kingdom
 
NCT01493336
BP27931, 2011-005185-37
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP