Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

December 27, 2012 updated by: CrystalGenomics, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm for CG200745
any progrossive solid cancer
Drug: CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Other Names:
  • No specific generic name yet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose in Single dose
Time Frame: On 22 days after administration
On 22 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CrystalGenomics, Inc.

Investigators

  • Principal Investigator: Tae Won Kim, MD, PhD, Seoul Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 31, 2012

Last Update Submitted That Met QC Criteria

December 27, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CG200745-1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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