Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2012 by CrystalGenomics, Inc..
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

CrystalGenomics, Inc.

ClinicalTrials.gov Identifier:

NCT01226407

First received: October 21, 2010

Last updated: December 27, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Solid Tumour	Drug: CG200745	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer

Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:

To determine the maximum tolerated dose in Single dose [ Time Frame: On 22 days after administration ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	36
Study Start Date:	September 2010
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm for CG200745 any progrossive solid cancer	Drug: CG200745 Multiple administration (IV) over the cycles untile MTD/LTD Other Name: No specific generic name yet

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

Eligibility


Ages Eligible for Study:	20 Years to 69 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226407

Contacts


Contact: Tae Won Kim, MD, PhD		twkimmd@amc.seoul.kr

Locations


Korea, Republic of
Seoul Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Tae Won Kim, MD, PhD twkimmd@amc.seoul.kr

Sponsors and Collaborators

CrystalGenomics, Inc.

Investigators


Principal Investigator:	Tae Won Kim, MD, PhD	Seoul Asan medical Center

More Information


Responsible Party:	CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:	NCT01226407 History of Changes
Other Study ID Numbers:	CG200745-1-01
Study First Received:	October 21, 2010
Last Updated:	December 27, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:


Solid Tumour

ClinicalTrials.gov processed this record on September 23, 2016

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