NCT01493336

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2012

Shorter than P25 for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

December 14, 2011

Last Update Submit

November 1, 2016

Conditions

Breast Cancer, Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

    Multiple sampling pre-dose to 6 hours post-dose

Secondary Outcomes (1)

  • Safety: Incidence of adverse events

    30 days

Study Arms (2)

Capecitabine RTD

EXPERIMENTAL
Drug: capecitabine RTDDrug: capecitabine [Xeloda]

Xeloda

ACTIVE COMPARATOR
Drug: capecitabine [Xeloda]

Interventions

capecitabine RTDDRUG

single oral dose

Capecitabine RTD
capecitabine [Xeloda]DRUG

single oral dose

Xeloda

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Unknown Facility

Nedlands, Western Australia, 6009, Australia

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

Unknown Facility

Grafton, 1010, New Zealand

Location

Unknown Facility

Glasgow, G12 0YN, United Kingdom

Location

Unknown Facility

Leeds, LS9 7TF, United Kingdom

Location

Unknown Facility

London, WC1E 6AU, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 15, 2011

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

NZ(2)GB(4)AU(2)