Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia - Tabular View

Tracking Information

First Received Date ^ICMJE

July 29, 2008

Last Updated Date

August 27, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hematological response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]
Symptomatic response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]
Splenomegaly response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00726232 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in PD markers (e.g. plasma cytokines) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Safety and tolerability assessed by monitoring adverse events [ Time Frame: Ongoing and end of study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia

Official Title ^ICMJE

An Open-Label Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea

Brief Summary

To evaluate the safety and efficacy profile of different treatment regimens of INCB018424 administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group will be refractory to hydroxyurea or for whom hydroxyurea is contraindicated.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Polycythemia Vera
Essential Thrombocythemia

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

105

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
Patient meets baseline clinical lab parameters

Exclusion Criteria:

Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years
Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
Clinically significant cardiac disease (NYHA Class III or IV)

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, Italy

Administrative Information

NCT ID ^ICMJE

NCT00726232

Responsible Party

Pamela Murphy, VP Communications & IR, Incyte Corporation

Study ID Numbers ^ICMJE

INCB 18424-256

Study Sponsor ^ICMJE

Incyte Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Edward Bradley, MD

Incyte Corporation

Information Provided By

Incyte Corporation

Verification Date

August 2009

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