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Sponsored by: |
TopoTarget A/S |
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Information provided by: | TopoTarget A/S |
ClinicalTrials.gov Identifier: | NCT00131261 |
The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors, including PXD101, have been shown to sensitize myeloma cells to the killing effect of other chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: PXD101 Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
United States, California | |
James Berenson, MD, Inc | |
West Hollywood, California, United States, 90069 | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Research Facility | |
New York, New York, United States, 10021 | |
Norway | |
Research Facility | |
Oslo, Norway, N-0407 | |
Research Facility | |
Bergen, Norway, N-5021 | |
Research Facility | |
Trondheim, Norway, N-7006 |
Responsible Party: | TopoTarget A/S ( Jan Fagerberg/Medical Director ) |
Study ID Numbers: | PXD101-301-G |
Study First Received: | August 17, 2005 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00131261 |
Health Authority: | United States: Food and Drug Administration; Norway: Norwegian Medicines Agency |
Multiple Myeloma Neoplasms |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |