Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

CrystalGenomics, Inc.36 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumour

Interventions

CG200745DRUG

Multiple administration (IV) over the cycles untile MTD/LTD

Eligibility

Sex: ALLMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

To determine the maximum tolerated dose in Single dose

Time frame: On 22 days after administration

Central Contacts

Tae Won Kim, MD, PhD

CONTACT

twkimmd@amc.seoul.kr

Data from ClinicalTrials.gov

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