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LeukemiaPhase 2NCT00960726

NOV-002 in Myelodysplastic Syndrome (MDS)

A Phase 2 study testing NOV-002 in people with Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Leukemia, Myelodysplastic Syndrome
What is being tested?
NOV-002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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.)

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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 and white blood cells and platelets.

Screening Tests:

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:

  • Your medical history will be recorded.
  • You will be asked about any drugs you have taken or may be taking.
  • You will have a physical exam, including measurement of your weight and vital signs (blood pressure, temperature, breathing rate, and heart rate).
  • Urine will be collected for routine tests.
  • Blood (about 7 teaspoons) will be drawn for routine tests and to check for HIV and hepatitis B and C.
  • If you have not had a bone marrow aspiration in the month before the screening tests, one will be performed to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
  • Women who are able to become pregnant will have a pregnancy test as part of the routine blood or urine collection. To take part in this study, the pregnancy test must be negative.

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.

Study Visits:

  • You will have study visits 1 time each week during Weeks 1-8 and 1 time each month during Months 3-12. At these visits, the following tests and procedures will be performed:
  • You will be asked about any drugs you have taken or may be taking and about any side effects you may have experienced.
  • Your vital signs will be measured.
  • Blood (about 5 teaspoons) will be drawn for routine tests.
  • You will have a physical exam 1 time each month while you are on study.
  • You will have a bone marrow aspiration every 3 months while you are on study to check the status of the disease.

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.

Long-Term Follow-Up:

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.

Being tested
NOV-002
Keywords
Leukemia, NOV-002, Myelodysplastic Syndrome, MDS
Medical subject headings
Leukemia, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOV-002Drug

    60 mg delivered daily subcutaneously for up to 12 months.

Study groups in NCT00960726
Study groupRoleWhat they receive
NOV-002ExperimentalNot described
Receives: Drug: NOV-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response (OR)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2009 (estimated)

Why it stopped: Study withdrawn at sponsor request.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00960726
Sponsor's protocol ID
2008-0673
Status last verified
Jul 2012
First submitted
17 Aug 2009
Last updated
30 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOV-002 in people with Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response (OR) (time frame: Baseline to measured progressive disease (anticipated treatment period 3 -12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.

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