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Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01226407
Recruitment Status : Unknown
Verified October 2012 by CrystalGenomics, Inc..
Recruitment status was:  Recruiting
First Posted : October 22, 2010
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Tracking Information
First Submitted Date  ICMJE October 21, 2010
First Posted Date  ICMJE October 22, 2010
Last Update Posted Date December 31, 2012
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
To determine the maximum tolerated dose in Single dose [ Time Frame: On 22 days after administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
Official Title  ICMJE Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
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
  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumour
Intervention  ICMJE Drug: CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Other Name: No specific generic name yet
Study Arms  ICMJE Experimental: Single Arm for CG200745
any progrossive solid cancer
Intervention: Drug: CG200745
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 27, 2012)
36
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2010)
24
Estimated Study Completion Date  ICMJE February 2013
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226407
Other Study ID Numbers  ICMJE CG200745-1-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CrystalGenomics, Inc.
Original Responsible Party Sang-Koo Lee/ Head of Preclinical studies, CrystalGenomics
Current Study Sponsor  ICMJE CrystalGenomics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tae Won Kim, MD, PhD Seoul Asan medical Center
PRS Account CrystalGenomics, Inc.
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP