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Sponsored by: |
TopoTarget A/S |
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Information provided by: | TopoTarget A/S |
ClinicalTrials.gov Identifier: | NCT00413075 |
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors.
Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
Condition | Intervention | Phase |
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Solid Tumor Lymphoma |
Drug: belinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 100 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Solid Tumor: Acceptable liver, renal and bone marrow function to include:
Lymphoma: Acceptable liver, renal and bone marrow function including the following:
Exclusion Criteria:
Within 4 weeks of enrollment:
Anticancer therapy, including:
Significant cardiovascular disease, including:
A marked baseline prolongation of QT/QTc interval, such as:
Contact: Karen Moeller, RN, Clinical Trial Manager | kam@topotarget.com | |
Contact: Lisbet Skinnes, RN, Head Clin Operations | lsk@topotarget.com |
United States, Connecticut | |
Yale New Haven Hospital | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Principal Investigator: Kevin Kelly, D.O. | |
United States, New York | |
Columbia University - Herbert Irving Cancer Center | Recruiting |
New York, New York, United States, 01132 | |
Principal Investigator: Dan Petrylak, M.D. | |
United States, Texas | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77230-1402 | |
Principal Investigator: George Blumenschein, Jr, M.D. | |
Denmark | |
Research Facility | Recruiting |
Copenhagen, Denmark | |
United Kingdom, Surrey | |
Research Facility | Recruiting |
London, Surrey, United Kingdom, SW3 6JJ |
Responsible Party: | TopoTarget A/S ( Jan Fagerberg/Medical Director ) |
Study ID Numbers: | PXD101-CLN-9 |
Study First Received: | December 18, 2006 |
Last Updated: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00413075 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Medicines Agency |
Solid tumors Adenosarcoma B-cell lymphoma belinostat bladder cancer Breast cancer Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Chondrosarcoma colorectal cancer Esophageal Neoplasms Fibrosarcoma head and neck cancer Hemangiosarcoma Hodgkins Disease |
kidney cancer Leiomyosarcoma Liposarcoma lung cancer lymphoma mesothelioma mesothelioma, cystic Mixed Tumor, Mesodermal Osteosarcoma Otorhinolaryngologic Neoplasms Ovarian cancer Parathyroid Neoplasms Prostate cancer sarcoma T-cell lymphoma |
Fibrosarcoma Otorhinolaryngologic Neoplasms Leiomyosarcoma Esophageal Neoplasms Lymphoma, B-Cell Soft Tissue Sarcomas Renal Cancer Lung Neoplasms Kidney Neoplasms Lymphoma, T-Cell Chondrosarcoma Osteogenic Sarcoma Ovarian Cancer Bladder Neoplasm Hodgkin Disease |
Lymphoma Kidney Cancer Immunoproliferative Disorders Ovarian Neoplasms Thyroid Neoplasms Hodgkin Lymphoma, Adult Urinary Bladder Neoplasms Hodgkin's Disease Breast Neoplasms Osteosarcoma Esophageal Cancer Hemangiosarcoma Carcinoma Carcinoma, Small Cell Lymphatic Diseases |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |