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Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) Clinical research trials and Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML). Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) clinical trial. Subjects frequently get the best healthcare possible for their Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)  Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
For Condition: Acute Myelogenous Leukemia,Myelodysplastic Syndrome
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.
Details: This is a Phase 1, open label, dose escalating study at five clinical sites to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome. This study will confirm the tolerability and assess the effects on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication (ITD).
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Each patient must meet the following inclusion criteria to be eligible to participate in the study. 1. Men and women who are over 18 years of age and have one of the following conditions: - AML with relapse within 12 months of the completion of consolidation therapy who are not to receive gemtuzumab-ozogomicin, or - AML with relapse after 12 months of the completion of consolidation therapy for whom, in the opinion of the investigator, the risk of alternative therapy outweighs the possible benefit, or - newly diagnosed AML refractory to conventional remission-induction chemotherapy ("refractory" is defined as >10% blasts in blood and/or bone marrow upon recovery from two cycles of standard cytarabine-based induction chemotherapy) or - newly diagnosed, or previously treated AML, greater than 60 years of age and not or no longer a candidate for conventional remission- induction chemotherapy or gentuzumab- ozogomicin 2. No reproductive potential (surgically, post- menopausal, or using two methods of contraception) 3. Demonstrated FLT-3 gene, internal tandem duplication mutation 4. ECOG performance status of 0 to 2 5. Has not received cytoreductive drug therapy for at least 4 weeks, and has not received hydroxyurea within 24 hours prior to first dose of the study drug 6. Has not received a bone marrow transplant or peripheral blood stem cell transplant within the last two months 7. Able to read and give written informed consent and has signed a consent form approved by the Investigator's Institutional Review Board (IRB) Exclusion Criteria Patients meeting any of the following criteria are not eligible to participate in the study: 1. Participated in an investigational drug study in the last 30 days 2. Serum Creatinine >2 mg/dL 3. Evidence of a clinically significant liver disease by history, physical examination and/or laboratory data (e.g. transaminases exceeding 3 x ULN and/or total bilirubin > 2 mg/dL 4. Known to have used illicit drugs within the last 30 days 5. Has an uncontrolled active infection 6. Pregnant or nursing mother 7. Candidate for conventional chemotherapy (except hydroxyurea), including growth factors or hormonal therapy for cancer 8. Any concomitant disease or condition which could interfere with or for which the treatment might interfere with the conduct of the study the, or which would, in the opinion of the Investigator and/or Sponsor, increase the risk of the patient's participation in the study. This includes but is not limited to alcoholism, drug dependency or abuse, psychiatric disease.
Total Enrollment: 60
Location and Contact Information:
Oregon Health Sciences University *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Lynne Nibert 800-589-9005
Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lynne Nibert 800-589-9005
UCLA Medical Center *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Lynne Nibert 800-589-9005
Ohio State University Medical Center *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Lynne Nibert 800-589-9005
Memorial Sloan Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lynne Nibert 800-589-9005
Additional Information:
Study ID Numbers: 01-301;
Study Start Date: May 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064584
Other Myelodysplastic Syndrome Studies:
1. Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
2. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
3. Phase II Study of CLOFARABINE in Adult Patients with Refractory or Relapsed Acute Myelogenous Leukemia
4. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
5. A Phase I Study of DT388GMCSF Fusion Protein in AML and CMML
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
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