Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
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ClinicalTrials.gov Identifier: NCT01226407 |
Recruitment Status : Unknown
Verified October 2012 by CrystalGenomics, Inc..
Recruitment status was: Recruiting
First Posted : October 22, 2010
Last Update Posted : December 31, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumour | Drug: CG200745 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2010 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Single Arm for CG200745
any progrossive solid cancer
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Drug: CG200745
Multiple administration (IV) over the cycles untile MTD/LTD
Other Name: No specific generic name yet |
- To determine the maximum tolerated dose in Single dose [ Time Frame: On 22 days after administration ]

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Ages Eligible for Study: | 20 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226407
Contact: Tae Won Kim, MD, PhD | twkimmd@amc.seoul.kr |
Korea, Republic of | |
Seoul Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Tae Won Kim, MD, PhD twkimmd@amc.seoul.kr |
Principal Investigator: | Tae Won Kim, MD, PhD | Seoul Asan medical Center |
Responsible Party: | CrystalGenomics, Inc. |
ClinicalTrials.gov Identifier: | NCT01226407 |
Other Study ID Numbers: |
CG200745-1-01 |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | December 31, 2012 |
Last Verified: | October 2012 |
Solid Tumour |