Spots Global Cancer Trial Database for Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
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Trial Identification
Brief Title: Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Official Title: A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer
Study ID: NCT01463982
Interventions
Study Description
Brief Summary: The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Detailed Description: Besides the main objective, there are 4 other objectives as follows: * To assess the safety of Oratecan in combination with capecitabine * To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies * To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hanmi Pharmaceuticals, Co., Ltd, Seoul, , Korea, Republic of
Contact Details
Name: Jina Jung, PhD
Affiliation: Hanmi Pharmaceuticals.Co.,Ltd
Role: STUDY_DIRECTOR
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