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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relative bioavailability: Area under the concentration-time curve (AUC)

Outcome Time Frame:

Multiple sampling pre-dose to 6 hours post-dose

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

New Zealand: Ministry of Health

Study ID:

BP27931

NCT ID:

NCT01493336

Start Date:

May 2012

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer, Colorectal Cancer
  • Breast Neoplasms
  • Colorectal Neoplasms

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