The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Administered orally
Administered orally or IV
Event Free Survival as Determined by Blinded Independent Review Committee
Event free survival as determined by blinded independent review committee.
Time frame: Baseline up to approximately 11 months
Event Free Survival as Determined by Investigator Assessment
Event free survival as determined by investigator assessment
Time frame: Baseline up to approximately 11 months
Overall Survival (OS)
Overall survival
Time frame: Baseline to date of death due to any cause (up to approximately 18 months)
Overall Response Rate (ORR)
Overall response rate
Time frame: Baseline up to approximately 3 months
Disease Control Rate (DCR)
Disease control rate
Time frame: Baseline through to disease progression (up to approximately 3 months )
Duration of Response (DoR)
Duration of response
Time frame: Date of Complete Response (CR) or Partial Response (PR) or Minor Response (MR) to date of disease progression or death (up to approximately 3 months )
Pharmacokinetic (PK): Abemaciclib Plasma Concentration
PK Abemaciclib Plasma Concentrations
Time frame: Cycle 1 through Cycle 4 (21 Day cycle)
Abemaciclib Acceptability and Palatability Questionnaire
Participants evaluated abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to select one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham (UAB) - Children's Hospital - The Alabama Center for Childhood Cancer and Blood -T
Birmingham, Alabama, United States
RECRUITINGPhoenix Children's Hospital
Phoenix, Arizona, United States
RECRUITINGUniversity Of California - San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGChildren's Hospital of Orange County - Orange
Orange, California, United States
COMPLETEDLucile Packard Children's Hospital (LPCH) - Stanford University
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGChildren's National Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGNicklaus Children's Hospital
Miami, Florida, United States
RECRUITINGThe University of Chicago Medicine
Chicago, Illinois, United States
RECRUITINGRiley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
COMPLETEDThe Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center
Baltimore, Maryland, United States
ACTIVE_NOT_RECRUITING...and 53 more locations
Time frame: Day 1 of Cycles 1 through 3 (21 Day Cycles)]