Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

NCT ID: NCT00131261

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-06-30

Brief Summary

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

PXD101

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valerio Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

enquiries@topotarget.com

Role: STUDY_CHAIR

Valerio Therapeutics

Locations

James Berenson, MD, Inc

West Hollywood, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Research Facility

New York, New York, United States

Rigshospitalet

Copenhagen, , Denmark

Research Facility

Bergen, , Norway

Research Facility

Oslo, , Norway

Research Facility

Trondheim, , Norway

Christie Hospital NHS Trust

Manchester, , United Kingdom

The Royal Marsden NHS Trust

Surrey, , United Kingdom

Countries

United States; Denmark; Norway; United Kingdom

Other Identifiers

PXD101-301-G

Identifier Type: -

Identifier Source: org_study_id