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Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

This study is currently recruiting participants.
Verified October 2012 by CrystalGenomics, Inc.
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 69 Years
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
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

No publications provided

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 May 19, 2013