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

Neoplasms Clinical Trial

Official title:

Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405065
• Other study ID #: HM-RAFI-101
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2015
• Est. completion date: May 16, 2018

Study information

• Verified date: August 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 16, 2018
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• HM95573
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Clinical	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
Secondary	Overall rsponse rate		6-12 weeks