|
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) conditions. Clinical Trials Search.org is a site dedicated 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) healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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 volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes 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. Participants typically obtain the most effective healthcare available for their Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML) condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
2. Allo Transplantation with Mylotarg, fludarabine and melphalan for AML, CML and MDS.
3. Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
4. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
5. Molecular Epidemiology of Childhood Leukemia in Northern and Central California
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
|
|
|
|
|
|
|
|
