Clinical trial · Interventional
CEP-701 for PH-negative Myelofibrosis
Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis
NCT00494585CI-TRIAL-00007247completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEP-701 | Drug | Lestaurtinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CEP-701
- description
- 80 mg orally twice a day for 30 days
- interventionNames
- Drug: CEP-701
Primary outcomes (1)
- measure
- Number of Participants With Objective Response
- timeFrame
- Response assessed after each 3 cycles (cycle = 30 days)
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDSantos 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 20008298