Clinical Trial to Evaluate Safety, Tolerability and Pharm... | NCT02405065

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

NCT02405065

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Aug 10, 2020Actual

Enrollment

72Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

HM95573

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2015Actual

Primary Completion Date

Jan 18, 2017Actual

Completion Date

May 16, 2018Actual

First Submitted Date

Jan 15, 2015

First Submission Date that Met QC Criteria

Mar 27, 2015

First Posted Date

Apr 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2020

Last Update Posted Date

Aug 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HM95573	Experimental	single arm	Drug: HM95573

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HM95573	Drug	BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops	HM95573

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall rsponse rate		6-12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yohan Kim, MD	Hanmi Pharmaceutical co., ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanmi Clinical		Seoul		05545	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided