CEP-701 for PH-negative Myelofibrosis

Study Description

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Brief Summary:

The goal of this clinical research study is to find out if CEP-701 can help control myelofibrosis (MF). The safety of CEP-701 will also be studied.

Condition or disease	Intervention/treatment	Phase
Leukemia; Myelofibrosis	Drug: CEP-701	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis
Study Start Date :	June 2007
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CEP-701; 80 mg orally twice a day for 30 days	Drug: CEP-701; 80 mg orally twice a day for 30 days; Other Name: lestaurtinib

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants With Objective Response [ Time Frame: Response assessed after each 3 cycles (cycle = 30 days) ]
   Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients with Chronic Idiopathic Myelofibrosis (CIMF) requiring therapy, including those 1) previously treated by CIMF-directed therapy and relapsed, intolerant, or refractory to therapy; or 2) if newly diagnosed then with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 10^9/L; risk group: 0 = low, 1 = intermediate, 2 = high), or with symptomatic spleen that is >/= 10cm below costal margin. However, patients with asymptomatic intermediate risk disease are not eligible.
• JAK2 mutation positive test
• Age of at least 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate liver and renal function: total bilirubin </=2.0 mg/dL, alanine aminotransferase (ALT or SGPT) </=2.0 x institutional upper limit of normal (ULN), and creatinine </=2.0 mg/dl
• Patients must be at least 2 weeks from prior chemotherapy, biological therapy, radiation therapy, major surgery, or other investigational anticancer therapy that is considered MF-directed, and have recovered from prior toxicities to Grade 0-1. Concurrent therapy with supportive care medications (hydroxyurea, anagrelide) is allowed during the study.
• All men of reproductive potential and women of child-bearing potential (WOCBP) must agree to practice effective contraception (iud, birth control pill, latex condoms, diaphragm) during the entire study period and for one month after the study ends, unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. WOCBP are women who are not menopausal for 12 months or no previous surgical sterilization."
• Ability to understand and willingness to sign the informed consent form
• Not willing to undergo, not a candidate for, or not having a donor for, a bone marrow transplant

Exclusion Criteria:

• Pregnant or nursing women, due to the unknown effects of therapy on the developing fetus or newborn infant.
• Patients diagnosed with another malignancy - unless following curative intent therapy the patient has been disease free for at least 3 years. Patients with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are eligible for this study
• Any condition, including serious medical condition, laboratory abnormality, or psychiatric illness, which places the subject at unacceptable risk as judged by the Principal Investigator, if he/she was to participate in the study
• Known positive for Human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C
• Presence of any gastrointestinal condition or concomitant medication use (e.g. coumadin) that would render a patient at high risk for gastrointestinal bleeding as judged by treating physician
• History of any upper or lower gastrointestinal bleeding in the 6 months prior to enrollment
• Elevated international normalized ratio (INR) or Partial thromboplastin time (PTT)

Contacts and Locations

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Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Cephalon

Investigators

Principal Investigator:	Srdan Verstovsek, M.D.	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

M.D. Anderson's website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1182/blood-2009-10-246363. Epub 2009 Dec 11.

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00494585 History of Changes
Other Study ID Numbers:	2007-0070; CS-2007-20040
First Posted:	June 29, 2007
Results First Posted:	May 4, 2011
Last Update Posted:	June 25, 2012
Last Verified:	June 2012

Keywords provided by M.D. Anderson Cancer Center:

CEP-701; Leukemia; Myelofibrosis; MF; JAK2	Tyrosine Kinase Inhibitor; Lestaurtinib; Chronic Idiopathic Myelofibrosis; CIMF

Additional relevant MeSH terms:

Primary Myelofibrosis; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases