A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies - NCT00719836-60637 (Clinical Trial 232555)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy232555.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Chicago |
|
State:
|
|
IL |
| Zip Code: |
|
60637 |
| 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 |
|
|
|
| Study is available at: |
|
The University of Chicago Hospitals
Chicago, IL 60637
United States
Primary Contact:
Peggy Green, RN
Email: mgreen@medicine.bsd.uchicago.edu
Phone: 773-834-2119 |
|
|
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: |
|
November 16, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|