Solid Tumour
Conditions
Keywords
Solid Tumour
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
Interventions
DRUGCG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Sponsors
CrystalGenomics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose in Single dose | On 22 days after administration |
Countries
South Korea
Contacts
Primary ContactTae Won Kim, MD, PhD
Outcome results
None listed