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

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05545
    • Hanmi Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability	Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall rsponse rate	6-12 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Study Director: Yohan Kim, MD, Hanmi Pharmaceutical co., ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2015
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): May 16, 2018

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HM-RAFI-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided