A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
This study has been terminated.
(Terminated due to dose limiting toxicity)
Sponsor:
TopoTarget A/S
Information provided by:
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00431340
First received: February 2, 2007
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: PXD101 |
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 Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by TopoTarget A/S:
Primary Outcome Measures:
- Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
- Safety of belinostat plus bortezomib.
Secondary Outcome Measures:
- Duration of response, time to response (TTR), and time to progression (TTP).
- Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
| Enrollment: | 4 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431340
Locations
| United States, California | |
| Oncotherapeutics | |
| West Hollywood, California, United States, 90069 | |
| United States, Maryland | |
| Center for cancer and blood disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
Sponsors and Collaborators
TopoTarget A/S
Investigators
| Principal Investigator: | James Berenson, MD | James R. Berenson, MD, Inc. |
More Information
No publications provided
| Responsible Party: | Jan Fagerberg/Medical Director, TopoTarget A/S |
| ClinicalTrials.gov Identifier: | NCT00431340 History of Changes |
| Other Study ID Numbers: | PXD101-CLN-16 |
| Study First Received: | February 2, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by TopoTarget A/S:
|
Multiple myeloma myeloma plasma cell myeloma bone marrow cancer myelomatosis |
Kahler's disease PXD101 belinostat bortezomib |
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 Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013