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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01226407
• Other study ID #: CG200745-1-01
• Status: Recruiting
• Phase: Phase 1
• First received: October 21, 2010
• Last updated: December 27, 2012
• Start date: September 2010
• Est. completion date: February 2013

Study information

• Verified date: October 2012
• Source: CrystalGenomics, Inc.
• Contact: Tae Won Kim, MD, PhD
• Email: twkimmd[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Solid Tumour

Intervention

Drug:
• CG200745
Multiple administration (IV) over the cycles untile MTD/LTD

Locations

Country	Name	City	State
Korea, Republic of	Seoul Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CrystalGenomics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose in Single dose		On 22 days after administration	Yes