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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00697502 |
Hypothesis:
Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines, conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is associated with greater tolerability to fluoropyrimidine as measured by lower toxicity but also lower response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS genotype, we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses of capecitabine and require higher doses to overcome fluoropyrimidine resistance. We designed this study to develop TYMS genotype specific dosing of capecitabine.
Aims:
Condition | Intervention | Phase |
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Solid Tumors |
Drug: Capecitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase I Study of Capecitabine In Patients With Solid Tumors |
Study Start Date: | May 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required genotype characteristics:
Exclusion Criteria:
Contact: Ross Andrew Soo, MBBS | 65-6772-4624 | Ross_Soo@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Ross Andrew Soo, MBBS 65-6772-4624 Ross_Soo@nuh.com.sg | |
Principal Investigator: Ross Andrew Soo, MBBS |
Principal Investigator: | Ross Andrew Soo, MBBS | National University Hospital, Singapore |
Study ID Numbers: | PG03/32/06 |
Study First Received: | June 11, 2008 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00697502 |
Health Authority: | Singapore: Domain Specific Review Boards |
Capecitabine |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |