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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02567331 |
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Date of registration:
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01/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
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Scientific title:
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An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02567331 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Bulgaria
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients greater than or equal to (>=) 18 years of age
- Metastatic colorectal cancer
Exclusion Criteria:
- Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
- Central nervous system and bone metastases
- Moderate or severe renal impairment
- Clinically significant cardiac disease
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome, or inability to take oral medication
- Malignancy within the last 5 years, except cured basal cell cancer of skin and cured
cancer in situ of uterine cervix
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: Capecitabine
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Primary Outcome(s)
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Incidence of adverse events
[Time Frame: up to approximately 1.5 years]
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Response rate, ie, percentage of participants with complete, partial, and overall response
[Time Frame: up to approximately 1.5 years]
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Secondary Outcome(s)
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Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n
[Time Frame: up to approximately 1.5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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