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Completed

NCT Number: NCT02405065

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

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

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi Clinical

Seoul, 05545, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HM95573

Drug

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

Primary outcomes

  1. Safety and tolerability

    Time frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Secondary outcomes

  1. Overall rsponse rate

    Time frame: 6-12 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 1, 2015
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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