|
Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation Clinical research trials and Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation health trials take place in a lot of 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 potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "O" Clinical Trials Conditions > Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation  Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
For Condition: Leukemia, Myeloid
Status: No longer recruiting
Sponsor(s): Cephalon ,
Synopsis: The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
Details: This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation - patient must have life expectancy of more than 2 months - patient must be fully recovered from reversible side effects of previous therapy for cancer EXCLUSION CRITERIA: - total bilirubin, ALT or AST greater than 2 times upper limit of normal - patient <65 years of age with estimated creatinine clearance less than 60 mL/min; patient >65 years of age with serum creatinine > 1.5 times the upper limit of normal (ULN) - received any investigational drug within past 4 weeks - GI disturbance/malabsorption that may affect absorption of CEP-701 - HIV positive - received NSAID within prior 14 days - has active infection
Total Enrollment: 37
Location and Contact Information:
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 70030
United States
Johns Hopkins Oncology Center, Bunting Blaustein Building
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: C0701a/202/ON/US;
Study Start Date: January 2002
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030186
Other Leukemia, Myeloid Studies:
1. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
2. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
3. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
4. Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
Related Studies:
Other Leukemia, Myeloid Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
|
|
|
|
|
|
|
|
