CEP-701 for PH-negative Myelofibrosis
Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis
2 other identifiers
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 leukemia
Started Jun 2007
Shorter than P25 for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
May 4, 2011
CompletedJune 25, 2012
June 1, 2012
2.9 years
June 28, 2007
April 7, 2011
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Objective Response
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). \[International Working Group on Myelofibrosis Research and Treatment\]
Response assessed after each 3 cycles (cycle = 30 days)
Study Arms (1)
CEP-701
EXPERIMENTAL80 mg orally twice a day for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Cephaloncollaborator
Study Sites (1)
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 20008298DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Srdan Verstovsek M.D./Associate Professor
- Organization
- The University of Texas M. D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Srdan Verstovsek, M.D.
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
June 29, 2007
Study Start
June 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 25, 2012
Results First Posted
May 4, 2011
Record last verified: 2012-06