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Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02405065
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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Brief Summary:
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: HM95573 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: HM95573
single arm
 Drug: HM95573
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ]

Secondary Outcome Measures :
  1. Overall rsponse rate [ Time Frame: 6-12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Hanmi Clinical
Seoul, Korea, Republic of, 05545
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Study Director: Yohan Kim, MD Hanmi Pharmaceutical co., ltd.
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02405065    
Other Study ID Numbers: HM-RAFI-101
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