To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study
Conditions
Interventions
Product Name: AMN107
Product Code: AMN107-AAA.001
Pharmaceutical Form: Capsule*
INN or Proposed INN: Nilotinib
CAS Number: AMN107
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Technical University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with: De novo AML or secondary AML from MDS who are not candidates for myelosuppressive chemotherapy, or De novo AML or secondary AML from MDS who have relapsed disease or are refractory to standard therapy - Patients at least 18 years or older - Patients with WHO performance status of 0 to 2 with a life expectancy under treatment of at least 3 months - Patients must have recovered from prior cytotoxic chemotherapy; treatment with Hydroxyurea or Ara-C is allowed until 24 hours to first administration of study drug. - Patients must have a serum creatinine of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with AML FAB M3. - Patients with an expected doubling of the peripheral blast within one week. - Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously. - Impaired cardiac function, including any one of the following: LVEF 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads Congenital long QT syndrome History of or presence of significant ventricular or atrial tachyarrhythmias Clinically significant resting bradycardia ( 450 msec on screening ECG (using the QTcF formula) Right bundle branch block plus left anterior hemiblock, bifascicular block Myocardial infarction within 12 months prior to starting Nilotinib Unstable angina diagnosed or treated during the past 12 months Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) - Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control. - Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study. - Patients who had more than 2 prior regimens for their current relapsed or current primary refractory disease - Patients with uncontrolled active infection. - Patient with any pulmonary infiltrate on the baseline chest X-ray known to be new in the previous 4 weeks. Prior treatment with any investigational drug within the preceding 4 weeks - Chronic treatment with systemic steroids or another immunosuppressive agent - Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases - Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. - Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration) - A known history of HIV seropositivity - Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) - Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin) - Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, imp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study;Secondary Objective: - To determine the duration of hematological response. - To evaluate overall survival. - To evaluate the safety profile of a combination treatment of Nilotinib and RAD001. - To evaluate improvement of symptomatic parameters. - To assess mTor, cKit and PDGF-R pathway activities during treatment as a predictive factor of response. ;Primary end point(s): To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study | — |
Countries
Germany
Outcome results
None listed