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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: |
NCT00467610 |
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Date of registration:
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26/04/2007 |
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Primary sponsor: |
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Public title:
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Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS
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Scientific title:
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A Phase 2, Open-Label, Multiple-Dose Study Investigating the Efficacy and Safety of Panhematin in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00467610 |
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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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United States
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Contacts
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Name:
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Jamile Shammo, 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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Rush University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A patient will be eligible for study participation if all of the following criteria are
met:
1. The patient must sign and date the IRB/IEC approved Informed Consent Form/HIPAA
Authorization prior to study participation.
2. Patient is at least 18 years of age.
3. If female:
1. Patient, either male or female, is either not of childbearing potential, defined
as postmenopausal for at least 1 year or surgically sterile (bilateral tubal
ligation, bilateral oophorectomy or hysterectomy), or if of childbearing
potential, must comply with an effective method of birth control acceptable to
the Investigator during the study (oral contraceptives, Depo-Provera,
intra-uterine device), for at least 1 month prior to enrollment and for 1 month
following the completion of the study.
2. Patient is not breastfeeding.
3. Patient of childbearing potential must have a negative urine or serum pregnancy
test during the screening period.
4. Patient has a diagnosis of low- or intermediate-1 risk MDS, as determined by the
International Prognostic Scoring (IPSS) (score of 0-1).
5. Patient must be transfusion dependent (i.e., received = 2 units over an 8-week period
prior to registration) or have a hemoglobin value = 10 g/dL on the screening
laboratories.
6. Patients must have = 10% blasts in the bone marrow and peripheral blood.
7. Patient must have a platelet counts > 50,000/microliters and absolute neutrophil
counts (ANC) >500/microliters.
8. Patient must have adequate hepatic and renal functions, defined as serum bilirubin,
serum glutamic-oxaloacetic transaminase (SGOT), and serum glutamate pyruvate
transaminase (SGPT) = 2 times the upper limit of normal (ULN), and creatinine = 1.5
times the ULN.
9. Patient must have an ECOG score of = 2.
10. The patient has a negative human immunodeficiency virus antibody (HIV) test result.
Exclusion Criteria:
A patient will be ineligible for study participation if any of the following criteria are
met:
1. The patient has a history of an allergic reaction or significant sensitivity to
Panhematin®.
2. The patient has taken or used any investigational drug or device in the 30 days prior
to screening.
3. The patient has chronic myelomonocytic leukemia (CMML).
4. The patient has a history of deep vein thrombosis or known hypercoagulable state.
5. The patient has a history of a pre-existing medical condition that, in the opinion of
the investigator, will interfere with the participation in the study.
6. The patient has poor peripheral venous access, if central venous access is not
available.
7. The patient has an uncontrolled active infection.
8. The patient has positive test results for hepatitis B surface antigen, and hepatitis
C virus antibody.
9. The patient has any other condition or prior therapy that, in the opinion of the
Investigator, would make the patient unsuitable for the study.
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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Myelodysplastic Syndrome
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Intervention(s)
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Drug: Panhematin
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Primary Outcome(s)
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Response rate (i.e., the number and percentage of patients demonstrating a complete response, partial response, or overall response) to Panhematin® at Week 8 (as defined by the International Working Group (IWG).
[Time Frame: 6 months]
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Safety and Tolerability of Panhematin®.
[Time Frame: 6 months]
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Secondary Outcome(s)
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Assessment of transfusion independence.
[Time Frame: 12 months]
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Hematological improvement rate ( i.e., the number and percentage of patients demonstrating a major and complete responses in each of the 3 cell lines, and combination of cell lines at Weeks 4 and 8 (as defined by the International Working Group (IWG).
[Time Frame: 12 months]
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Mean change in ferritin concentrations from Baseline (Day 1) to Weeks 4 and 8, and end of study
[Time Frame: 12 months]
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Mean number of days/treatment required for complete response to Panhematin®.
[Time Frame: 12 months]
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The number and percent of patients demonstrating a complete response, partial response, or overall response to Panhematin® at Week 4.
[Time Frame: 3 months]
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Secondary ID(s)
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06011001
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MDS 2005-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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