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

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

This study is currently recruiting participants.
Verified by Incyte Corporation, March 2008

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
Estimated Primary Completion Date:	September 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

Contacts


Contact: Sara Malhotra, PhD	302-498-6830	smalhotra@incyte.com

Locations


United States, California
		Recruiting
	Highland, California, United States, 92346

United States, Florida
		Recruiting
	Boynton Beach, Florida, United States, 33435

United States, New York
		Not yet recruiting
	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
First Received:	March 12, 2008
Last Updated:	April 14, 2008
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 November 30, 2008