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

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verastem, Inc.

Criteria

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