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CEP-701 for PH-negative Myelofibrosis

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ClinicalTrials.gov Identifier: NCT00494585
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : May 4, 2011
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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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, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494585


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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Additional Information:
M.D. Anderson's website  This link exits the ClinicalTrials.gov site

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

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    Key Record Dates
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