The main objective of this study is to determine the maximum tolerated dose (MTD) of
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Full eligibility criteria for NCT01455571
Ages eligible for Study
19 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
1) Histologically or cytologically confirmed advanced solid tumor 2) Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3) 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 4) Aged ≥19 5) Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 6) A life expectancy greater than 12 weeks 7) Adequate bone marrow (WBC≥4,000/mm3 platelet≥100000/mm3, hemoglobin≥9.0g/dl and ANC≥ 1500/mm3, renal (Creatinine≤1.5mg/dl) and liver function (AST/ALT/ALP ≤ 3 x upper limit of normal and total bilirubin≤2mg/dl) and no abnormal heart and lung function However, AST/ALT/ALP ≤ 5 x upper limit of normal for patients with liver metastases and ALP level ≤ 5 x upper limit of normal for patients with bone metastases are allowed 8)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
1) Patients with hematopoietic malignancies,uncontrolled infection, ileus, CNS metastasis.
Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF<40% 4) Patients who have GI malabsorption or difficulty taking oral medication 5) Patients who have psychiatric or congenital disorder 6) Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 7) Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.) 8) Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons 9) Subjects who were administered with other investigational products within 30 days before screening.
Subjects who, in the investigator's opinion, cannot be participated.
All locations for NCT01455571
Korea, Republic of (1)
Seoul National University
Seoul, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT01455571. The sponsor of the trial is Hanmi Pharmaceutical Company Limited and it is looking for 55 volunteers for the current phase.
Official trial title: Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B
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