Breast Cancer, Colorectal CancerPhase 1NCT01493336
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
A Phase 1 study testing capecitabine RTD and capecitabine [Xeloda] in people with Breast Cancer, Colorectal Cancer, run by Hoffmann-La Roche at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer
- What is being tested?
- capecitabine RTD and capecitabine [Xeloda]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesin 3 countries
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United Kingdom4 sites
Study site
Glasgow, G12 0YN
Study site
Leeds, LS9 7TF
Study site
London, WC1E 6AU
Study site
Newcastle upon Tyne, NE7 7DN
Australia2 sites
Study site
Adelaide, South Australia, 5000
Study site
Nedlands, Western Australia, 6009
About this study
Official title: 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
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
- Breast Cancer, Colorectal Cancer
- Being tested
- capecitabine RTD, capecitabine [Xeloda]
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine RTDDrug
single oral dose
capecitabine [Xeloda]Drug
single oral dose
capecitabine [Xeloda]Drug
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine RTD | Experimental | Not described Receives: Drug: capecitabine RTD; Drug: capecitabine [Xeloda] |
| Xeloda | Active comparator | Not described Receives: Drug: capecitabine [Xeloda] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability: Area under the concentration-time curve (AUC)
Measured: Multiple sampling pre-dose to 6 hours post-dose
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493336
- Sponsor's protocol ID
- BP27931
- Other IDs
- 2011-005185-37
- Status last verified
- Nov 2016
- First submitted
- 14 Dec 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01493336
- Acronym / sponsor ID
- BP27931
- Conditions
- Breast Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine RTD | Experimental | Drug: capecitabine RTD, Drug: capecitabine [Xeloda] |
| Xeloda | Active comparator | Drug: capecitabine [Xeloda] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine RTDsingle oral dose | Drug | Capecitabine RTD |
| capecitabine [Xeloda]single oral dose | Drug | Xeloda |
| capecitabine [Xeloda]standard treatment | Drug | Capecitabine RTD, Xeloda |
Primary outcome
Relative bioavailability: Area under the concentration-time curve (AUC)
Time frame: Multiple sampling pre-dose to 6 hours post-dose
1 secondary outcome
Safety: Incidence of adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Breast Cancer, Colorectal Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine RTD and capecitabine [Xeloda] in people with Breast Cancer, Colorectal Cancer, run by Hoffmann-La Roche at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative bioavailability: Area under the concentration-time curve (AUC) (time frame: Multiple sampling pre-dose to 6 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.