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| Sponsor: | TopoTarget A/S |
|---|---|
| Collaborator: |
Spectrum Pharmaceuticals, Inc |
| Information provided by: | TopoTarget A/S |
| ClinicalTrials.gov Identifier: | NCT00413075 |
Purpose
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 |
|---|---|---|
|
Solid Tumor Lymphoma |
Drug: belinostat |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Eligibility| 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:
Contacts and Locations| United States, Connecticut | |
| Yale New Haven Hospital | |
| New Haven, Connecticut, United States, 06520 | |
| United States, New York | |
| Columbia University - Herbert Irving Cancer Center | |
| New York, New York, United States, 01132 | |
| New York University Cancer Institute | |
| New York, New York, United States, 10016 | |
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77230-1402 | |
| Denmark | |
| Research Facility | |
| Copenhagen, Denmark | |
| United Kingdom | |
| Research Facility | |
| London, Surrey, United Kingdom, SW3 6JJ | |
More Information
| Responsible Party: | Lars Damstrup, MD, PhD/Medical Director, TopoTarget A/S |
| ClinicalTrials.gov Identifier: | NCT00413075 History of Changes |
| Obsolete Identifiers: | NCT00411476 |
| Other Study ID Numbers: | PXD101-CLN-9 |
| Study First Received: | December 18, 2006 |
| Last Updated: | April 28, 2011 |
| 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 |
|
Lymphoma Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |