Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by CrystalGenomics, Inc.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01226407
First received: October 21, 2010
Last updated: December 27, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Solid Tumour
Drug: CG200745
Phase 1

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

Resource links provided by NLM:


Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose in Single dose [ Time Frame: On 22 days after administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm for CG200745
any progrossive solid cancer
Drug: CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Other Name: No specific generic name yet

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
  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226407

Contacts
Contact: Tae Won Kim, MD, PhD twkimmd@amc.seoul.kr

Locations
Korea, Republic of
Seoul Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Tae Won Kim, MD, PhD       twkimmd@amc.seoul.kr   
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Principal Investigator: Tae Won Kim, MD, PhD Seoul Asan medical Center
  More Information

No publications provided

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01226407     History of Changes
Other Study ID Numbers: CG200745-1-01
Study First Received: October 21, 2010
Last Updated: December 27, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:
Solid Tumour

ClinicalTrials.gov processed this record on September 14, 2014