NCT02405065

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

January 15, 2015

Last Update Submit

August 6, 2020

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

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

Secondary Outcomes (1)

  • Overall rsponse rate

    6-12 weeks

Study Arms (1)

HM95573

EXPERIMENTAL

single arm

Drug: HM95573

Interventions

HM95573DRUG

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

HM95573

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Clinical

Seoul, 05545, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Yohan Kim, MD

    Hanmi Pharmaceutical co., ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

April 1, 2015

Study Start

January 12, 2015

Primary Completion

January 18, 2017

Study Completion

May 16, 2018

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

KR(1)