Spots Global Cancer Trial Database for A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
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Trial Identification
Brief Title: A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
Official Title: A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics
Study ID: NCT01806376
Conditions
Interventions
Study Description
Brief Summary: 1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study 2. Experimental Design： A phase Ⅰ study of single-center 3. Test drug: Subutinib Maleate capsules 4. Sample size≥20
Detailed Description: The primary objective of this study is to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study, to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate capsules.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Li jin, doctor
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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