Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573
- Registration Number
- NCT02405065
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
- Detailed Description
Besides the main objective, there are 3 other objectives as follows:
* To evaluate the anti-cancer effect of HM95573 in solid tumor patients
* To investigate the pharmacokinetic profile of HM95573 after oral administration.
* To investigate biomarkers related to the safety and efficacy of HM95573.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Patients must be 20 years of age or older
- Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.
- Estimated life expectancy of at least 12 weeks
- Histologically or cytologically confirmed advanced solid tumor
Exclusion Criteria
- Symptomatic or uncontrolled central nervous system metastases
- Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.
- Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HM95573 HM95573 single arm
- Primary Outcome Measures
Name Time Method Safety and tolerability Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
- Secondary Outcome Measures
Name Time Method Overall rsponse rate 6-12 weeks
Trial Locations
- Locations (1)
Hanmi Clinical
🇰🇷Seoul, Korea, Republic of