NOV-002 in Myelodysplastic Syndrome (MDS)

NCT00960726 | Withdrawn Phase 2

• 1 other identifier: 2008-0673
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia; Myelodysplastic Syndrome

Keywords

Leukemia; NOV-002; Myelodysplastic Syndrome; MDS

Outcome Measures

Primary Outcomes (1)

• Overall Response (OR)

  Baseline to measured progressive disease (anticipated treatment period 3 -12 months)

Study Arms (1)

NOV-002

EXPERIMENTAL

Drug: NOV-002

Interventions

NOV-002 DRUG

60 mg delivered daily subcutaneously for up to 12 months.

NOV-002

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cellectar Biosciences, Inc.: collaborator

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

NOV 002

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Gautam Borthakur, MBBS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07