The main objective of this study is to determine the maximum tolerated dose (MTD) of
Drug: HM781-36B tablets
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Full eligibility criteria for NCT01455584
Ages eligible for Study
19 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Histologically or cytologically confirmed advanced solid tumor
Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
A life expectancy greater than 12 weeks
Adequate bone marrow, renal and liver function.
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures
Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
Patients who have GI malabsorption or difficulty taking oral medication
Patients who have psychiatric or congenital disorder
Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
All locations for NCT01455584
Korea, Republic of (1)
Seoul National University Hospital
Seoul, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT01455584. The sponsor of the trial is Hanmi Pharmaceutical Company Limited and it is looking for 20 volunteers for the current phase.
Official trial title: Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile
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