Back to resultsA Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
Primary Purpose
Breast Cancer, Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
capecitabine RTD
capecitabine [Xeloda]
capecitabine [Xeloda]
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer, Colorectal Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capecitabine RTD
Xeloda
Arm Description
Outcomes
Primary Outcome Measures
Relative bioavailability: Area under the concentration-time curve (AUC)
Secondary Outcome Measures
Safety: Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493336
Brief Title
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine RTD
Arm Type
Experimental
Arm Title
Xeloda
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
capecitabine RTD
Intervention Description
single oral dose
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
single oral dose
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
Relative bioavailability: Area under the concentration-time curve (AUC)
Time Frame
Multiple sampling pre-dose to 6 hours post-dose
Secondary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Grafton
ZIP/Postal Code
1010
Country
New Zealand
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
London
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
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