Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00131261
First received: August 17, 2005
Last updated: November 12, 2014
Last verified: November 2014
  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:


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

  1. Signed informed consent
  2. A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.

    Diagnostic criteria for multiple myeloma:

    A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type > 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.

    B M-component in serum and/or urine in lower concentration than indicated above in 'A'.

    C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.

    The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.

  3. Evaluable disease (as defined above)
  4. Adequate bone marrow and hepatic functions including the following:

    1. WBC > 2.5 x 109/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 50x109/l
    2. Total bilirubin ≤1.5 x upper normal limit.
    3. AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit
  5. Serum potassium within normal range.
  6. Age ≥18 years
  7. Performance status (PS) ≤2 (ECOG scale)
  8. Estimated life expectancy greater than 3 months
  9. Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and in a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.

Exclusion criteria

  1. Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
  2. Active infection or any medical condition likely to interfere with trial procedures.
  3. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
  4. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
  5. Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 ml/min.
  6. Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
  7. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
  8. Other malignant diseases requiring treatment
  9. Non-secretory multiple myeloma or symptomatic amyloidosis
  10. Pregnant or breast-feeding women
  11. Women of childbearing age and potential, who do not use effective contraception
  12. 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 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
Investigators
Study Chair: enquiries@topotarget.com TopoTarget A/S
  More Information

No publications provided

Responsible Party: 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 12, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Belinostat
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Histone Deacetylase Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2014