Acute Myeloid Leukemia (AML)
|Closed||Acute Myeloid Leukemia (AML);||Phase II||
The goal of this clinical research study is to learn if MK-2206 can help to control AML that has come back or has not responded to treatment. The safety of this drug will also be studied.
- Patients must have histologically or cytologically confirmed AML other then acute promyelocytic leukemia
- Patients must have persistent or relapsing disease requiring 2nd salvage therapy (e.g. treatment for second relapse or for primary refractory disease after failure of two prior treatment regimens); duration of prior complete remission <12 months if not refractory disease. Patients with prior autologous and allogeneic hematopoietic stem cell transplantation are eligible if patients are off immunosuppression for >1 month and have no evidence of active graft versus host disease (GVHD) except grade 1 skin GVHD.
- Patients age >/= 60 years with less than two prior treatment regimens not candidates for or have refused standard chemotherapy, excluding subjects with acute promyelocytic leukemia (APL) or with favorable cytogenetic abnormalities [inv16, t(8;21)].
- Patient at the time of enrollment should not be a candidate for allogeneic stem cell transplantation.
- Patient is male or female and >/=18 years of age on the day of signing informed consent.
- ECOG performance status
- Patient must have adequate organ function as indicated by the following laboratory values: Serum creatinine or calculated creatinine clearance/=60 mL/min for patients with creatinine levels >1.5 x institutional ULN; Serum total bilirubin 2 x ULN, unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis; AST (SGOT) and ALT (SGPT)
- Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-hCG within 72 hours prior to receiving the first dose of study medication.
- Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent.
- Patient is able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis.
- Patients may not be receiving any other investigational agents.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery.
- Active uncontrolled infection.
- Patients with CNS involvement
- Systemic chemotherapy (with the exception of hydroxyurea) within 14 days (or within 5 half-lives for an investigational agent) prior to first dose of study drug, unless there is evidence of rapidly progressive disease. Persistent chronic clinically significant toxicities from prior chemotherapy must not be > grade 1.
- Patient has known hypersensitivity to the components of study drug or its analogs.
- Patient has a history or current evidence of clinically significant heart disease including: 1) Uncontrolled congestive heart failure, unstable angina pectoris, 2) uncontrolled cardiac arrhythmia, 3) history or current evidence of a myocardial infarction during the last 6 months, 4) QTc prolongation >450 msec (Bazett's Formula), 5) congenitally long QT syndrome, and/or has received any marketed or experimental compound in the last 4 weeks or 5 half lives (whichever is shorter) prior to entering the study with possible or known effects of QT prolongation.
- Patient with evidence of symptomatic bradycardia, or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2).
- Patient with uncontrolled hypertension (i.e., BP >/= 160/90 mHg ). Patients who are controlled on antihypertensive medication will be allowed to enter the study.
- Patient with poorly controlled diabetes defined as HBA1C >9%.
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Patient is known to be Human Immunodeficiency Virus (HIV)-positive with history of AIDS defining conditions; or CD4 cells prior to leukemia onset
- Patient has active Hepatitis B or C or active Hepatitis A.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.