CEP-701 for PH-negative Myelofibrosis

This study has been completed.

Study NCT00494585 Information provided by M.D. Anderson Cancer Center

First Received on June 28, 2007. Last Updated on June 6, 2011 History of Changes

Results First Received: April 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Leukemia Myelofibrosis
Intervention:	Drug: CEP-701

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 6/28/2007 through 10/25/2007. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 27 participants registered, 5 participants were ineligible to participate.

Reporting Groups

	Description
CEP-701	80 mg orally twice daily for 30 days

Participant Flow: Overall Study

	CEP-701
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
CEP-701	80 mg orally twice daily for 30 days

Baseline Measures

	CEP-701
Number of Participants [units: participants]	22
Age [units: years] Median ( Full Range )	61 ( 38 to 83 )
Gender [units: participants]
Female	6
Male	16
Region of Enrollment [units: participants]
United States	22

Outcome Measures

1. Primary:

Number of Participants With Objective Response [ Time Frame: Response assessed after each 3 cycles (cycle = 30 days) ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Srdan Verstovsek M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org

No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Santos FP, Kantarjian HM, Jain N, Manshouri T, Thomas DA, Garcia-Manero G, Kennedy D, Estrov Z, Cortes J, Verstovsek S. Phase 2 study of CEP-701, an orally available JAK2 inhibitor, in patients with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis. Blood. 2010 Feb 11;115(6):1131-6. Epub 2009 Dec 11.

Responsible Party:	Srdan Verstovsek, M.D./ Associate Professor, The University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00494585 History of Changes
Other Study ID Numbers:	2007-0070, CS-2007-20040
Study First Received:	June 28, 2007
Results First Received:	April 7, 2011
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration