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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




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