Status:
UNKNOWN
Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Solid Tumour
Eligibility:
All Genders
20-69 years
Phase:
PHASE1
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 determ...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01226407
Start Date
September 1 2010
End Date
February 1 2013
Last Update
December 31 2012
Active Locations (1)
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1
Seoul Asan Medical Center
Seoul, South Korea, 138-736