Status:
COMPLETED
AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the proportion of patients achieving Morphologic Complete Response (CR), Morphologic CR with incomplete count recovery (CRp) or Partial Response (PR) as best response...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed AML other than acute promyelocytic leukemia (2008 World Health Organization (WHO) classification)
- Patients must have persistent or relapsing disease requiring 2nd salvage therapy (e.g. treatment for second or higher 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
- The Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Serum creatinine or calculated creatinine clearance =\< 1.5 \* upper limit of normal (ULN) OR \>= 60 mL/min for patients with creatinine levels \> 1.5 \* institutional ULN
- Serum total bilirubin =\< 2 \* ULN OR direct bilirubin =\< ULN for patients with total bilirubin levels \> 2 \* ULN, unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis
- asparate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT /SGPT) =\< 2.5 \* ULN or =\< 5 \* ULN unless considered to be secondary to leukemic involvement
- Fasting serum glucose =\< 150 mg/dl
- HBA1c =\< 9%
- Female patient of childbearing potential must have a negative serum or urine pregnancy test beta- Human chorionic gonadotropin (hCG) within 72 hours prior to receiving the first dose of study medication; the effects of MK-2206 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treatment physician immediately
- Patient, or the patient"s legal representative, has voluntarily agreed to participate by giving written informed consent
- Patient is able to swallow tablets and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis
Exclusion
- 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
- 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
- Patients with central nervous system (CNS) involvement
- Patient has known hypersensitivity to the components of study drug or its analogs
- Uncontrolled congestive heart failure, unstable angina pectoris
- Uncontrolled cardiac arrhythmia
- History or current evidence of a myocardial infarction during the last 6 months
- corrected Q-T interval (QTc) prolongation \> 450 msec (Bazett's Formula)
- Congenitally long QT syndrome, 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 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., i.e., sustained systolic blood pressure \>= 160 or diastolic \>= 90); 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 =\< 400 cells/mm\^3; or patients receiving antiretroviral therapy that affects CYP3A4 such as protease inhibitors, efavirenz, nevirapine, or zidovudine
- Patient has active Hepatitis B or C or active Hepatitis A
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01253447
Start Date
October 1 2010
End Date
April 1 2014
Last Update
August 27 2018
Active Locations (2)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109