View Clinical Trial (Medical Research Study)

A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies - NCT00719836-98109(Clinical Trial 232557)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Seattle
State:  
WA
Zip Code: 98109
Conditions: Acute Myelogenous Leukemia - Chronic Myelogenous Leukemia - Chronic Myelomonocytic Leukemia - Myelodysplastic Syndromes - Myelofibrosis
Purpose: This is a phase I dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced myeloid malignancies.
Study summary:
Criteria: Inclusion Criteria: - Subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following: - Subjects with Acute Myelogenous Leukemia (AML) - Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase - Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis - Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) - Subjects with Advanced Myelofibrosis (MF) - Age ≥ 18 years old - Eastern Co-operative Oncology Group (ECOG) performance status 0-2 - All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug - Able to understand and willing to sign the informed consent form Exclusion Criteria: - Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase - Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study - Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study - Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy) - Known active Hepatitis A, B or C - Women who are pregnant or lactating
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.