Phase I Study of MK0683 in Combination With Bortezomib in Multiple Myeloma Patients

This study is currently recruiting participants.

Verified by Merck, April 2009

First Received: March 4, 2009 Last Updated: April 1, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00858234

Purpose

The clinical study determines recommended clinical dose, and evaluates the safety, tolerability, pharmacokinetics and efficacy of MK0683 in combination with bortezomib in patients with relapsed and/or refractory multiple myeloma in Japan.

Condition	Intervention	Phase
Multiple Myeloma	Drug: vorinostat Drug: bortezomib	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Suberoylanilide hydroxamic acid Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multicenter, Open-Label, Phase I Study of MK0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma

Further study details as provided by Merck:

Primary Outcome Measures:

Any clinical or laboratory adverse experiences [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics (Area under the curve ) [ Time Frame: 11 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0683	Drug: vorinostat MK0683 (400 mg) Oral, once daily treated for Day 1 through 14 of a 21 day cycle Drug: bortezomib bortezomib (1.3 mg/m2 ) intravenous push on Day 1, 4, 8 and 11 of a 21 day cycle

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Is 20 Years Of Age Or Older.
Patient Has An Established Diagnosis Of Multiple Myeloma Based On The Myeloma Diagnostic Criteria
Patient Has Received At Least 1 But Not More Than 3 Prior Anti-Myeloma Regimens And Has Progressive Disease After The Most Recent Treatment Regimen
Patient Must Have Adequate Organ Function

Exclusion Criteria:

Patient Has Had A Prior Allogeneic Bone Marrow Transplant Or Plans To Undergo Any Type Of Bone Marrow Transplantation During The Study
Patient Has Known Hypersensitivity To Any Components Of Bortezomib Or MK0683
Patient Has Active Hepatitis B Or C, Plasma Cell Leukemia, Or Is Hiv Positive
Patient Has Had Prior Treatment With MK0683 Or Hdac Inhibitors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858234

Locations

Japan, Chiyodaku
Merck Ltd., Japan	Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi 81-3-6272-1547

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_557, MK0683-098
Study First Received:	March 4, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00858234 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vorinostat
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Protease Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Vorinostat
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009