Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Verastem, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age
Pathologic confirmation of AML or B-ALL
Must have relapsed or refractory AML or B-ALL with no alternate therapy of proven benefit
ECOG status of 0 or 1
Adequate renal function \[creatinine less than or equal to 1.5x ULN\] or GFR of at least 60mL/min
Adequate hepatic function via total bilirubin, AST, and ALT
Corrected QT interval of less than 470 ms (via Fridericia correction formula)
Negative pregnancy test for women of child bearing potential
Willingness to use adequate birth control throughout participation for both men and women
You may not be if
Diagnosis of acute promyelocytic leukemia
Active grade 2 or higher acute GVHD at time of study entry or active chronic GVHD (moderate or severe)
Gastrointestinal conditions which could interfere with the swallowing or absorption of study medication
Diagnosis of currently active CNS leukemia
Known infection with HIV or AIDS (testing not required)
Known active Hepatitis A, B or C (testing not required)
Patients being actively treated for a secondary malignancy
Cancer-directed therapy within 14 days of the first dose of study drug or 5 half-lives, whichever is longer
Major surgery within 28 days prior to the first dose of study drug
Use of an investigational drug within 28 days or 5 half-lives whichever is longer
Women who are pregnant or breastfeeding
Evidence of uncontrolled infections requiring antibiotic therapy; potential subjects with known or suspected infections on stable antibiotic therapy for 72 hours may be enrolled
Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
