Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573
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|ClinicalTrials.gov Identifier: NCT02405065|
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : August 10, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: HM95573||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors|
|Actual Study Start Date :||January 12, 2015|
|Actual Primary Completion Date :||January 18, 2017|
|Actual Study Completion Date :||May 16, 2018|
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
- Safety and tolerability [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ]
- Overall rsponse rate [ Time Frame: 6-12 weeks ]
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405065
|Korea, Republic of|
|Seoul, Korea, Republic of, 05545|
|Study Director:||Yohan Kim, MD||Hanmi Pharmaceutical co., ltd.|
|Responsible Party:||Hanmi Pharmaceutical Company Limited|
|Other Study ID Numbers:||
|First Posted:||April 1, 2015 Key Record Dates|
|Last Update Posted:||August 10, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|