Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00697502
Eligibility Criteria:
Inclusion Criteria:
1. Cytologically or histologically confirmed advanced or metastatic non- hematologic malignancy that had failed previous therapies or cancer for which there are no standard treatment options.
2. Presence of at least one uni-dimensional measurable lesion as defined by the RECIST criteria.
3. Required genotype characteristics:
* Group 1: TSER genotype 2R/2R or 2R/3R
* Group 2: TSER genotype 3R/3R
4. Able to swallow capsules
5. Age\>=18 years
6. Kanorfsky performance status of at least 70% or ECOG performance status \<2 (Appendix A)
7. Life expectancy of at least 3 months
8. Hb \>=9 g/dL
9. ANC \>=1.5 x 10\^9/L
10. Platelet count \>=100 x 10\^9/L.
11. Total bilirubin and serum creatinine \<=1.5x upper limits of normal reference range (ULN)
12. Alkaline phosphatase, AST/ALT levels \<=2.5x upper limit of normal. If hepatic metastases are present, these parameters could be \<=10x the ULN.
13. Women of reproductive age and men must agree to practice effective contraception during the entire study period. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child- bearing potential. Females with childbearing potential must have a negative serum pregnancy test within 7days prior to study enrolment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
14. Signed written informed consent
Exclusion Criteria:
1. Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 28 days prior to study drug administration (6 weeks for mitomycin or nitroureas) and not recovered.
2. Patients who have not recovered from major surgery
3. Any woman pregnant or lactating.
4. Known CNS metastases
5. Renal impairment with a creatinine clearance \<=50mL/min (as calculated according to Cockcroft and Gault formula) or serum creatinine \> ULN
6. Clinically significant cardiac disease, eg. Congestive cardiac failure, symptomatic coronary heart disease, cardiac arrhythmia or myocardial infarction within the last 12 months.
7. Known HIV infection
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, other serious uncontrolled concomitant disease, psychiatric illness/ social situation that would limit study compliance.
9. Known allergies to any component of the study drug
10. Lack of physical integrity of the upper gastrointestinal tract or those with malabsorption syndrome
11. Organ allografts
12. Known dihydropyrimidine dehydrogenase deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00697502
Study Brief:
Protocol Section:
NCT00697502