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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00360035 |
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Date of registration:
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01/08/2006 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
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Scientific title:
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A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF) |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00360035 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Jean Viallet, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gemin X, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed myelofibrosis with myeloid metaplasia.
- No limitations on allowable type and amount of prior therapy.
- Patients must have normal organ function.
- Must be willing to submit to blood sampling for planned PK and PD analyzes.
- Must have ability to understand and willingness to sign a written informed consent
form.
Exclusion Criteria:
- No other agents or therapies administered with the intent to treat malignancy.
- Patients with prior exposure to obatoclax.
- Uncontrolled, intercurrent illness.
- Pregnant women and women who are breast feeding.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myelofibrosis
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Intervention(s)
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Drug: Obatoclax mesylate (GX15-070MS)
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Primary Outcome(s)
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Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
[Time Frame: 1 Year]
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Secondary Outcome(s)
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Bone marrow aspirates and biopsies
[Time Frame: 8 weeks to 1 year]
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Peripheral blood counts
[Time Frame: 4 Weeks to 1 Year]
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Transfusion and growth factor requirements
[Time Frame: 8 weeks to 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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