Return to List

Study Summary
No. 2006-0411:.......Leukemia......Srdan Verstovsek......Leukemia
.
Study Summary Title
Study Summary
Number:		2006-0411
Study Title:A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients with Myelofibrosis with Myeloid Metaplasia (MF)
.
Physician New Patient Referral
Name:Srdan VerstovsekPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7305
Contact us about clinical trials
.
General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Every 2 weeks
Treatment
Agents:		GX15-070MSHome Care:0
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		0
Description/
Intervention:		The goal of this clinical research study is to learn if GX15-070MS can help to
control MF. The safety of this drug will also be studied.
.
Study Objectives / Outcomes
  • Determine the response rate (CR, PR, CI) to GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.
  • Characterize the safety profile of GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.
  • Determine the steady state pharmacokinetic (PK) parameters of GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.
  • Determine the pharmacodynamic (PD) response to GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.
    • .
    Study Status Information
    Study Activation / Registration Date:07/25/2006
    IRB Review and Approval Date:06/07/2006
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Terminated
    Projected Accrual:55
    .
    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Patients must have histologically confirmed myelofibrosis with myeloid metaplasia

    2) Patients requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, 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 splenomegaly. )

    3) Patients must be greater than or equal to 18 years of age

    4) Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2

    5) Patients must have normal organ function as defined below: ·Total bilirubin: less than or equal to 2 mg/dL unless resulting from hemolysis ·AST(SGOT)/ALT(SGPT): less than or equal to 2.5 x institutional upper limit of normal ·Creatinine: within normal institutional limits OR ·Calculated creatinine clearance: greater than or equal to 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal ·Baseline hematological parameters: no restrictions

    6) Women of child-bearing potential must have a negative serum pregnancy test result prior to study entry. In addition, because of the potential for unknown risks to an unborn child that could result from exposure to GX15 070MS, women of child-bearing potential and men with partners of child-bearing potential must agree to abstain from sexual activity which would result in pregnancy for the duration of study participation

    7) Patients must be willing to submit to blood sampling for the planned PK and PD analyses

    8) Patients must have the ability to understand and the willingness to sign a written informed consent form
    Exclusion Criteria:1) Patients receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy. In addition, patients who have had prior exposure to GX15 070MS are also excluded from this study

    2) Patients with a history of allergic reactions attributed to components of the formulated product. (These are polyethylene glycol (PEG 300) and Polysorbate 20 (Tween 20) which are known to be associated with a risk of hypersensitivity reactions.)

    3) Patients with a history of seizure disorders

    4) Patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; prolonged QTc interval of more than 450 msec on screening EKG; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements.

    5) Pregnant women and women who are breast feeding
    .
    Links
    Registration Number:
    Other Links:
    .
    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center