NOV-002 in Myelodysplastic Syndrome (MDS)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Cellectar Biosciences, Inc.

Criteria

Inclusion Criteria:

1. Age greater than or equal to 18 years

2. 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.

3. 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

4. The patient must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections

5. Has a diagnosis of myelodysplastic syndrome and IPSS score of less than or equal to 1

6. 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.

7. 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).

8. Must have discontinued any growth factor for a period of 3 weeks prior to enrollment

9. 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 Criteria:

1. Pregnant female or nursing mother

2. Active second malignancy excluding carcinoma in-situ of uterine cervix, basal or squamous cancer of skin

3. Active hepatitis B or C infection

4. Known HIV positive

5. On oral steroids (prednisone or equivalent) greater than 10 mg/day

6. NOV-002 is contraindicated in patients with known hypersensitivity to any of the components of NOV-002