Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
NCT ID: NCT01226407
Last Updated: 2012-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
36 participants
INTERVENTIONAL
2010-09-30
2013-02-28
Brief Summary
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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
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2. Adverse Events will be coded to preferred therm and body system using the CTCAE
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm for CG200745
any progrossive solid cancer
CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Interventions
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CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* history of CNS metasis
* hyper-sensitivy of study drug
* pregancy or lactating
* administered other HDAC inhibitor within 4 weeks of screening
20 Years
69 Years
ALL
No
Sponsors
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CrystalGenomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tae Won Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul Asan medical Center
Locations
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Seoul Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Tae Won Kim, MD, PhD
Role: primary
Other Identifiers
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CG200745-1-01
Identifier Type: -
Identifier Source: org_study_id