Status:
WITHDRAWN
NOV-002 in Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cellectar Biosciences, Inc.
Conditions:
Leukemia
Myelodysplastic Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if NOV-002 can help to restore bone marrow and blood levels in patients who have MDS. The safety of this drug will also be studied.
Detailed Description
The Study Drug: NOV-002 is a type of blood cell production stimulating drug. NOV-002 is believed to stimulate the bone marrow to increase production of mature cells in the bloodstream, including red ...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years). Acceptable methods of birth control are: cervical cap or diaphragm with spermicide, condom, oral birth control pills, intrauterine device (IUD), or implanted or injectable birth control.
- The patient must have the ability to understand and the willingness to sign a written informed consent form and agree to abide by the trial restrictions and to return for the required assessments
- The patient must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
- Has a diagnosis of myelodysplastic syndrome and IPSS score of less than or equal to 1
- Documented cytopenias persistent for 2 months defined as:
- Red cell transfusion dependence defined as receiving 4 or more units of red cells within a period of 8 weeks for anemia of hemoglobin less than 9 gm/dL; and/or
- Untransfused hemoglobin of 10 gm/dL or less on two occasions greater than or equal to 1 week apart; and/or
- Platelet count less than 50 x 10(9) /dL on two occasions greater than or equal to 1 week apart; and/or
- Neutropenia defined as ANC less than 1 x 10(6) /dL on two occasions greater than or equal to 1 week apart.
- Adequate organ function defined as:
- Bilirubin less than or equal to 2.5 mg/dL (unless clearly attributable to hemolysis);
- Creatinine less than or equal to 2mg/dL or calculated creatinine clearance greater than 50 ml/min;
- AST or ALT less than 3 times the upper limit of institutional normal (ULN).
- Must have discontinued any growth factor for a period of 3 weeks prior to enrollment
- Up to one prior conventional or experimental therapy for MDS (not including growth factors and transfusion) is allowed but there must be a washout of 4 weeks prior to enrollment from any such therapy (examples include lenalidomide, hypomethylating agent etc.)
Exclusion
- Pregnant female or nursing mother
- Active second malignancy excluding carcinoma in-situ of uterine cervix, basal or squamous cancer of skin
- Active hepatitis B or C infection
- Known HIV positive
- On oral steroids (prednisone or equivalent) greater than 10 mg/day
- NOV-002 is contraindicated in patients with known hypersensitivity to any of the components of NOV-002
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00960726
Last Update
July 30 2012
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