NCT01226407

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 31, 2012

Status Verified

October 1, 2012

Enrollment Period

2.4 years

First QC Date

October 21, 2010

Last Update Submit

December 27, 2012

Conditions

Solid Tumour

Keywords

Solid Tumour

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose in Single dose

    On 22 days after administration

Study Arms (1)

Single Arm for CG200745

EXPERIMENTAL

any progrossive solid cancer

Drug: CG200745

Interventions

CG200745DRUG

Multiple administration (IV) over the cycles untile MTD/LTD

Also known as: No specific generic name yet
Single Arm for CG200745

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Interventions

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

Study Officials

  • Tae Won Kim, MD, PhD

    Seoul Asan medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae Won Kim, MD, PhD

CONTACT

twkimmd@amc.seoul.kr

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

October 21, 2010

First Posted

October 22, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 31, 2012

Record last verified: 2012-10

Locations

KR(1)