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

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

January 8, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00639002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Multiple Myeloma

Intervention ^ICMJE

Drug: INCB018424

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00639002

Responsible Party

Sara Malhotra, Incyte Project Manager, Incyte Corporation

Study ID Numbers ^ICMJE

INCB 18424-255

Study Sponsor ^ICMJE

Incyte Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sundar Jagannath, MD

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

Information Provided By

Incyte Corporation

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP