Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
20 Years
69 Years
Both
Solid Tumour
Trial Information
Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose in Single dose
Outcome Time Frame:
On 22 days after administration
Safety Issue:
Yes
Principal Investigator
Tae Won Kim, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul Asan medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
CG200745-1-01
NCT ID:
NCT01226407
Start Date:
September 2010
Completion Date:
February 2013
Related Keywords:
- Solid Tumour
- Solid Tumour
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