NOV-002 in Myelodysplastic Syndrome (MDS)
|First Received Date ICMJE||August 17, 2009|
|Last Updated Date||July 27, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Overall Response (OR) [ Time Frame: Baseline to measured progressive disease (anticipated treatment period 3 -12 months) ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00960726 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||NOV-002 in Myelodysplastic Syndrome (MDS)|
|Official Title ICMJE||Phase 2 Study of NOV-002 in Low and Intermediate-1 Risk Myelodysplastic Syndrome|
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.
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 and white blood cells and platelets.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drug NOV-002 through a needle under the skin 1 time each day while you are on study.
The study staff will teach you and/or a caregiver how to inject the study drug. The study staff will also give you written copy of instructions on how and when you should inject the study drug.
You will be given diary cards to record when and where on your body you inject the study drug, as well as any side effects that may occur. If you miss a dose of study drug, you should note that on your diary card and take the study drug the next day as scheduled. You should not take a double, "make-up" dose at that time.
You must store the study drug in a refrigerator and out of the reach of children. You will be asked to bring all leftover study drug to each study visit.
Length of Study:
You will take the study drug for up to 12 months. You will be taken off study if you have intolerable side effects, if the disease gets worse, or if the doctor thinks it is in your best interest.
After you have finished taking the study drug for any reason, the following procedures will be performed for about 12 months, but will be stopped if you start receiving a different treatment or if the disease gets worse:
Blood (about 5 teaspoons) will be drawn for routine tests 1 time each month. You will have a bone marrow aspiration every 3 months.
This is an investigational study. NOV-002 is not FDA approved or commercially available. At this time, it is only being used in research.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: NOV-002
60 mg delivered daily subcutaneously for up to 12 months.
|Study Arm (s)||Experimental: NOV-002
Intervention: Drug: NOV-002
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00960726|
|Other Study ID Numbers ICMJE||2008-0673|
|Has Data Monitoring Committee||No|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||Novelos Therapeutics|
|Information Provided By||M.D. Anderson Cancer Center|
|Verification Date||July 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP