Back to resultsDose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
Primary Purpose
Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
VS-4718
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Acute Myeloid Leukemia focused on measuring Leukemia, Acute Leukemia, Relapsed Leukemia, Refractory Leukemia, Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental VS4718
Arm Description
Oral VS-4718 administered BID during a 28 day cycle.
Outcomes
Primary Outcome Measures
To find the maximum tolerated dose of VS-4718
In the absence of a dose limiting toxicity (DLT), each subject will receive VS-4718 for a minimum of 28 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles until disease progression or other treatment discontinuation criteria have been met. It is estimated that subjects could potentially receive VS-4718 for up to an additional 2-3 cycles before withdrawal criteria apply.
Safety and Tolerability of VS-4718 Measurements
Specific key measures/observations used to assess safety and tolerability will be: serious adverse events, incidence and severity of adverse events, physical exams (including vital sign measurements), ECGs, and clinical laboratory evaluations (chemistry, hematology, coagulation, urinalysis)
Secondary Outcome Measures
Measure Pharmacokinetics of VS-4718
Systemic VS-4718 concentration as measured in plasma samples versus time by dosing cohort using descriptive statistics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02215629
Brief Title
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
Official Title
A Phase I Dose Escalation Study of VS-4718, A Focal Adhesion Kinase Inhibitor, In Subjects With Relapsed or Refractory Acute Myeloid Leukemia or B-Cell Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verastem, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Keywords
Leukemia, Acute Leukemia, Relapsed Leukemia, Refractory Leukemia, Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental VS4718
Arm Type
Experimental
Arm Description
Oral VS-4718 administered BID during a 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
VS-4718
Primary Outcome Measure Information:
Title
To find the maximum tolerated dose of VS-4718
Description
In the absence of a dose limiting toxicity (DLT), each subject will receive VS-4718 for a minimum of 28 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles until disease progression or other treatment discontinuation criteria have been met. It is estimated that subjects could potentially receive VS-4718 for up to an additional 2-3 cycles before withdrawal criteria apply.
Time Frame
Dose Escalation will occurr according to the standard 3+3 design where three subjects are dosed with the same dosage in the first Cycle (of 28 days); subjects will be evaluated for DLTs on Days: 1, 8, 15, 22 and 28 of first Cycle
Title
Safety and Tolerability of VS-4718 Measurements
Description
Specific key measures/observations used to assess safety and tolerability will be: serious adverse events, incidence and severity of adverse events, physical exams (including vital sign measurements), ECGs, and clinical laboratory evaluations (chemistry, hematology, coagulation, urinalysis)
Time Frame
Safety and tolerability of VS-4718 will be evaluated in each Cycle of 28 days; more specifically, evaluations will occur at a minimum on Days 1, 8, 15, 22, and 28 of the first Cycle
Secondary Outcome Measure Information:
Title
Measure Pharmacokinetics of VS-4718
Description
Systemic VS-4718 concentration as measured in plasma samples versus time by dosing cohort using descriptive statistics
Time Frame
Measured concentrations during Cycle 1 on Days 1, 2, 15, and 16. Also on Cycle 2 Day 1 for subjects that continue on study after Cycle 1.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop Youssoufian, MD
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
We'll reach out to this number within 24 hrs