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

Hanmi Pharmaceutical Company Limited1 site in 1 country72 target enrollmentJanuary 12, 2015

ConditionsNeoplasms

InterventionsHM95573

DrugsHM95573

Overview

Phase: Phase 1
Intervention: HM95573
Conditions: Neoplasms
Sponsor: Hanmi Pharmaceutical Company Limited
Enrollment: 72
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 12, 2015

End Date

May 16, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hanmi Pharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility 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.