Status:
COMPLETED
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer, Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01493336
Start Date
May 1 2012
End Date
October 1 2012
Last Update
November 2 2016
Active Locations (8)
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1
Adelaide, South Australia, Australia, 5000
2
Nedlands, Western Australia, Australia, 6009
3
Christchurch, New Zealand, 8011
4
Grafton, New Zealand, 1010