Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia

Verastem

Status and phase

Withdrawn

Phase 1

Conditions

Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Relapsed or Refractory Acute Myeloid Leukemia

Treatments

Drug: VS-4718

Study type

Interventional

Funder types

Industry

Identifiers

NCT02215629

VS-4718-102

Details and patient eligibility

About

The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of leukemia patients and to find the right dose of VS-4718 for future clinical trials.

Other purposes of this study include:

Testing for study drug VS-4718 levels in blood over time and what happens to the study drug in patients.
To find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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