Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Colorectal Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine RTD | Drug | — | UNRESOLVED |
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine RTD
- interventionNames
- Drug: capecitabine RTD
- Drug: capecitabine [Xeloda]
- type
- ACTIVE_COMPARATOR
- label
- Xeloda
- interventionNames
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Relative bioavailability: Area under the concentration-time curve (AUC)
- timeFrame
- Multiple sampling pre-dose to 6 hours post-dose
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available