Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma - Full Text View

Sponsored by:	TopoTarget A/S
Information provided by:	TopoTarget A/S
ClinicalTrials.gov Identifier:	NCT00131261

Purpose

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

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Belinostat

U.S. FDA Resources

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

Further study details as provided by TopoTarget A/S:

Study Start Date:

February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

A confirmed diagnosis of multiple myeloma in patients who have failed at least two prior lines of therapy
Adequate bone marrow and hepatic functions
Performance status (PS) less than 2 (Eastern Cooperative Oncology Group [ECOG] scale)
Estimated life expectancy greater than 3 months

Exclusion criteria

Anti-cancer therapy within the last 4 weeks
Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures
Significant cardiovascular disease
A marked baseline prolongation of QT/QTc interval
Patients with renal insufficiency
Non-secretory multiple myeloma or symptomatic amyloidosis
Pregnant or breast-feeding women
Women of childbearing age and potential who do not use effective contraception
Known HIV positivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131261

Locations

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

Sponsors and Collaborators

TopoTarget A/S

More Information

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

Keywords provided by TopoTarget A/S:

Multiple Myeloma
Neoplasms

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009