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Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Solid Tumour Drug: CG200745 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To determine the maximum tolerated dose in Single dose [ Time Frame: On 22 days after administration ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226407


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

Locations
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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
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Principal Investigator: Tae Won Kim, MD, PhD Seoul Asan medical Center
More Information
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Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01226407     History of Changes
Other Study ID Numbers: CG200745-1-01
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: October 2012

Keywords provided by CrystalGenomics, Inc.:
Solid Tumour