Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
- Registration Number
- NCT01226407
- Lead Sponsor
- CrystalGenomics, Inc.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm for CG200745 CG200745 any progrossive solid cancer
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose in Single dose On 22 days after administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul Asan Medical Center
🇰🇷Seoul, Korea, Republic of