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CEP-701 for PH-Negative Myelofibrosis
This study is ongoing, but not recruiting participants.
First Received: June 28, 2007   Last Updated: November 7, 2008   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Cephalon
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494585
  Purpose

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


Condition Intervention Phase
Leukemia
Myelofibrosis
Drug: CEP-701
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To investigate the efficacy of CEP-701 in patients with MF, in achieving objective improvements in disease status. [ Time Frame: 11/2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of CEP-701 in MF patients. [ Time Frame: 11/2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: June 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
CEP-701
Drug: CEP-701
80mg orally twice a day for 30 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 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 INR or PTT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: The University of Texas M.D. Anderson Cancer Center ( Srdan Verstovsek, M.D./ Associate Professor )
Study ID Numbers: 2007-0070, CS-2007-20040
Study First Received: June 28, 2007
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00494585     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
CEP-701
Leukemia
Myelofibrosis
MF
JAK2
Tyrosine Kinase Inhibitor
Lestaurtinib

Additional relevant MeSH terms:
Myeloid Metaplasia
Lymphatic Diseases
Leukemia
Neoplasms
Myelofibrosis
Neoplasms by Histologic Type
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on November 05, 2009