Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00111813

Purpose

The purposes of this study are:

To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in patients with advanced multiple myeloma
To assess the safety and tolerability of this regimen and to document the patient's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Phase I Clinical Trial of Vorinostat (MK0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Suberoylanilide hydroxamic acid Bortezomib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Maximum tolerated dose (MTD) of the combination of oral vorinostat and bortezomib in patients with multiple myeloma [ Time Frame: Day 1 to Day 21 in the Phase 1 part of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of this combination regimen of vorinostat and bortezomib as measured by incidence of toxicity during each treatment cycle [ Time Frame: Day 1 up to disease progression, toxicity or death ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	September 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 vorinostat; bortezomib	Drug: vorinostat Dose escalation study starting with vorinostat 200 mg b.i.d. capsules and rising up to vorinostat 300 mg b.i.d. capsules, twice daily. Treatment in 21 day cycles. Up to 24 weeks of treatment. Drug: Bortezomib Dose escalation with bortezomib 0.7 mg/m2 injection rising up to 1.3 mg/m2 injection, twice weekly. Treatment in 21 day cycles. Up to 24 weeks of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with refractory or relapsed multiple myeloma
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine patient's ability to perform daily activities)
Adequate bone marrow reserve
Adequate hepatic and renal function
Ability to swallow capsules
3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

Patients who plan to have a bone marrow transplant within 4 weeks of start of treatment
Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
Patients with other active/uncontrolled clinically significant illness
Pregnant or nursing female patients
Patients who received bortezomib within 3 months of start of this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111813

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_018, MK0683-015
Study First Received:	May 25, 2005
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00111813 History of Changes
Health Authority:	United States: Food and Drug Administration

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 February 08, 2010