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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Experimental VS4718
Oral VS-4718 administered BID during a 28 day cycle.
Drug: VS-4718



Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Verastem, Inc.
Investigators
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT02215629    
Other Study ID Numbers: VS-4718-102
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: October 2015
Keywords provided by Verastem, Inc.:
Leukemia
Acute Leukemia
Relapsed Leukemia
Refractory Leukemia
Acute Myeloid Leukemia
B-Cell Acute Lymphoblastic Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases