A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

NCT ID: NCT00431340

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-06-30

Brief Summary

This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.

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

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple myeloma.
• Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
• Progressive disease.
• Age >= 18 years.
• Karnofsky performance status >= 60%
• Acceptable liver function:

• Bilirubin =< 1.5 x ULN (upper limit of normal)
• Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN
• Acceptable hematologic status:

• Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
• Platelet count >= 100 x 109/L
• Hemoglobin >= 9 g/dL
• Coagulation status PT-INR/PTT =< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
• Serum potassium within normal range.
• Estimated life expectancy greater than 3 months.
• Signed, written IRB (institutional Review Board)-approved informed consent.

Exclusion Criteria

• Non-secretory multiple myeloma or symptomatic amyloidosis.
• Hypersensitivity to bortezomib, boron, or mannitol.
• Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
• Less than 4 weeks since prior use of other investigational agents.
• Serious concomitant systemic disorders (e.g. active infection).
• Significant cardiovascular disease.
• Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
• Central nervous system disorders requiring neuroleptics / anti-convulsants.
• Peripheral sensory neuropathy of ≥ Grade 2
• Renal insufficiency defined as a creatinine clearance of < 30 ml/min.
• Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
• Pregnant or breast-feeding women.
• Known HIV positivity.
• Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
• Altered mental status which precludes an understanding of the Informed Consent Document.

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

Sponsors

Valerio Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oncotherapeutics

West Hollywood, California, United States

Center for cancer and blood disorders

Bethesda, Maryland, United States

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

PXD101-CLN-16

Identifier Type: -

Identifier Source: org_study_id