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

Phase 1

Completed

• Conditions: Breast Cancer, Colorectal Cancer
• Interventions: Drug: capecitabine RTD; Drug: capecitabine [Xeloda]

• Registration Number: NCT01493336
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Capecitabine RTD	capecitabine RTD	-
Xeloda	capecitabine [Xeloda]	-
Capecitabine RTD	capecitabine [Xeloda]	-

Primary Outcome Measures

Name	Time	Method
Relative bioavailability: Area under the concentration-time curve (AUC)	Multiple sampling pre-dose to 6 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	30 days