Status:
WITHDRAWN
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Verastem, Inc.
Conditions:
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02215629
End Date
November 1 2016
Last Update
January 27 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.