Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02215629|
Recruitment Status : Withdrawn
First Posted : August 13, 2014
Last Update Posted : January 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Acute Myeloid Leukemia Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia||Drug: VS-4718||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||November 2016|
Experimental: Experimental VS4718
Oral VS-4718 administered BID during a 28 day cycle.
- To find the maximum tolerated dose of VS-4718 [ 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 ]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 [ 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 ]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)
- Measure Pharmacokinetics of VS-4718 [ 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. ]Systemic VS-4718 concentration as measured in plasma samples versus time by dosing cohort using descriptive statistics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215629
|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|