Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

This study has been completed.
Information provided by (Responsible Party):
TopoTarget A/S Identifier:
First received: August 17, 2005
Last updated: November 29, 2013
Last verified: November 2013

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by TopoTarget A/S:

Enrollment: 25
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: January 2007 (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

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00131261

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
Copenhagen, Denmark, 2100
Research Facility
Bergen, Norway, N-5021
Research Facility
Oslo, Norway, N-0407
Research Facility
Trondheim, Norway, N-7006
United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
The Royal Marsden NHS Trust
Surrey, United Kingdom, SM2 5NG
Sponsors and Collaborators
TopoTarget A/S
  More Information

No publications provided

Responsible Party: TopoTarget A/S Identifier: NCT00131261     History of Changes
Other Study ID Numbers: PXD101-301-G
Study First Received: August 17, 2005
Last Updated: November 29, 2013
Health Authority: United States: Food and Drug Administration
Norway: Norwegian Medicines Agency

Keywords provided by TopoTarget A/S:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histone Deacetylase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents processed this record on October 20, 2014