This is a Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor in Patients With Multiple Myeloma - Full Text View

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00639002

Purpose

The purpose of this study is to determine clinical efficacy and safety of INCB018424, a small molecule Janus kinase (JAK) inhibitor, in patients with refractory or relapsed multiple myeloma.

Condition	Intervention	Phase
Relapsed Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma	Drug: INCB018424	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Two Stage, Open-Label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-Inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Safety and tolerability of patients and response rates will be assessed using International Uniform Response Criteria (IRC) for multiple myeloma for all patients treated with study medication. [ Time Frame: End Of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study preliminary effectiveness of oral INCB018424 alone or in combination with dexamethasone in a patient population diagnosed with multiple myeloma. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	March 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: INCB018424 INCB018424 25 mg BID

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed diagnosis of multiple myeloma with evidence of measurable disease.
Relapsed or refractory disease with at least one line of prior therapy.
Adequate bone marrow reserve

Exclusion Criteria:

Received anti-cancer medications or investigational therapy in the past 28 days
Intracranial disease or epidural disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639002

Locations

United States, California

Highland, California, United States, 92346
United States, Florida

Boynton Beach, Florida, United States, 33435
United States, New York

New York, New York, United States, 10011

Sponsors and Collaborators

Incyte Corporation

Investigators

Principal Investigator:

Sundar Jagannath, MD

St. Vincent's Comprehensive Cancer Center, New York, New York

More Information

Responsible Party:	Incyte Corporation ( Sara Malhotra, Incyte Project Manager )
Study ID Numbers:	INCB 18424-255
Study First Received:	March 12, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00639002
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009