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Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

Solid Tumour Clinical Trial

Official title:
Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01226407
Study type Interventional
Source CrystalGenomics, Inc.
Contact Tae Won Kim, MD, PhD
Email twkimmd@amc.seoul.kr
Status Recruiting
Phase Phase 1
Start date September 2010
Completion date February 2013
View Details
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