Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573
NCT ID: NCT02405065
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2015-01-12
2018-05-16
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HM95573
single arm
HM95573
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
Interventions
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HM95573
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Yohan Kim, MD
Role: STUDY_DIRECTOR
Hanmi Pharmaceutical co., ltd.
Locations
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Hanmi Clinical
Seoul, , South Korea
Countries
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Other Identifiers
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HM-RAFI-101
Identifier Type: -
Identifier Source: org_study_id
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