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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT02405065

Collaborator

(none)

Enrollment

Location

Arm

40.1

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 12, 2015

Actual Primary Completion Date :

Jan 18, 2017

Actual Study Completion Date :

May 16, 2018

Arms and Interventions

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

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

Primary Outcome Measures

Safety and tolerability [Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1]

Secondary Outcome Measures

Overall rsponse rate [6-12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hanmi Clinical	Seoul		Korea, Republic of	05545

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Study Director: Yohan Kim, MD, Hanmi Pharmaceutical co., ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT02405065

Other Study ID Numbers:

HM-RAFI-101

First Posted:

Apr 1, 2015

Last Update Posted:

Aug 10, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Aug 10, 2020