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Sponsors and Collaborators: |
Cancer Therapeutics Research Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00321594 |
RATIONALE: PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of PXD101 and to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Drug: belinostat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of PXD101 in Patients With Unresectable Hepatocellular Carcinoma With Pharmacokinetic and Pharmacodynamic Evaluation |
Estimated Enrollment: | 61 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation phase I study followed by a phase II study.
After completion of study therapy, patients are followed for up to 8 weeks.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for the phase I portion of this study. A total of 37 patients will be accrued for the phase II portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No marked baseline prolongation of QT/QTc interval, including the following:
No significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent use of any of the following:
Hong Kong | |
Prince of Wales Hospital | Recruiting |
Shatin, New Territories, Hong Kong | |
Contact: Winnie Yeo 852-2632-2118 | |
Singapore | |
Cancer Institute at National University Hospital | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Boon C. Goh, MD 65-6772-4617 | |
National Cancer Centre - Singapore | Recruiting |
Singapore, Singapore, 169610 | |
Contact: Toh Han Chong, MD, MBBS, MRCP 65-6436-8200 |
Principal Investigator: | Winnie Yeo | Prince of Wales Hospital |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000463519, CTRG-HC06/21/05, NCI-7237 |
Study First Received: | May 2, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00321594 History of Changes |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Gastrointestinal Neoplasms |
Hepatocellular Carcinoma Adenocarcinoma Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |