Examine Maximum Tolerated Dose and Pharmacokinetic and Ph... | NCT01226407

Studies
Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

NCT01226407

Sponsor

CrystalGenomics, Inc.

Status

Unknown status

Last Update Posted

Dec 31, 2012Estimated

Enrollment

36Estimated

Phase

Phase 1

Conditions

Solid Tumour

Interventions

CG200745

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2013Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Oct 21, 2010

First Submission Date that Met QC Criteria

Oct 21, 2010

First Posted Date

Oct 22, 2010Estimated

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

Dec 27, 2012

Last Update Posted Date

Dec 31, 2012Estimated

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

Open label, single dose and phase I study.

The primary objective: To determine the maximum tolerated dose in Single dose

The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.

Detailed Description

Number of Subjects: 28~36, dose escalation (2~6 subject of each step)
Adverse Events will be coded to preferred therm and body system using the CTCAE

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

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm for CG200745	Experimental	any progrossive solid cancer	Drug: CG200745

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CG200745	Drug	Multiple administration (IV) over the cycles untile MTD/LTD	Single Arm for CG200745

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the maximum tolerated dose in Single dose		On 22 days after administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

from 20 years old to 69 years old
diagnosed with progressive solid cancer
In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected.
Evaluated 0-1 of ECOG
Expected life duration is within 3 months

Exclusion Criteria:

Major surgery except tumor-removal surgery received within 2 weeks of screening.
history of CNS metasis
hyper-sensitivy of study drug
pregancy or lactating
administered other HDAC inhibitor within 4 weeks of screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae Won Kim, MD, PhD	Contact			twkimmd@amc.seoul.kr

Overall Officials

Name	Affiliation	Role
Tae Won Kim, MD, PhD	Seoul Asan medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Asan Medical Center	Recruiting	Seoul		138-736	South Korea

Type	Date	Date Unknown
Release	Jun 13, 2019
Reset	Aug 1, 2019
Release	Jan 4, 2022
Reset	Mar 8, 2022
Release	Apr 18, 2022
Reset	Jan 18, 2023
Release	Jan 19, 2023
Reset	Nov 6, 2023
Release	Nov 21, 2023
Reset	Apr 25, 2024

Submission Tracking

Estimated Results First Submitted Date

Jun 13, 2019

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 13, 2019			Aug 1, 2019
Jan 4, 2022

Intervention Browse Module

MeSH Terms

ID	Term
C572619	N1-(3-(dimethylamino)propyl)-N8-hydroxy-2-((naphthalene-1-loxy)methyl)oct-2-enediamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided