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Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00131261
First received: August 17, 2005
Last updated: November 8, 2012
Last verified: December 2009
History of Changes
  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 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:

U.S. FDA Resources

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)
  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
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Norway
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: Jan Fagerberg/Medical Director, TopoTarget A/S
ClinicalTrials.gov Identifier: NCT00131261     History of Changes
Other Study ID Numbers: PXD101-301-G
Study First Received: August 17, 2005
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration
Norway: Norwegian Medicines Agency

Keywords provided by TopoTarget A/S:
Multiple Myeloma
Neoplasms

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
 Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 17, 2013