Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
Phase 2
120
about 10 years
1–39
11 sites in CO, DC, IL +7
What this study is about
Researchers are testing whether ribociclib and everolimus or ribociclib and temozolomide can help extend the lives of children and young adults with certain types of brain tumors. The trial will involve giving a treatment to patients whose tumors have specific genetic changes.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Everolimus
- 2.Take Ribociclib
- 3.Take Temozolomide (TMZ)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
mTOR inhibitor, ribociclib, temozolomide
oral (Oral Tablet), injection, intravenous
Primary: Establish MTD and RP2D of ribociclib and everolimus (Part 2, Stratum D), Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0 (Part 1- initial feasibility study), Overall Survival (OS) in DIPG (Part 2, Stratum B), Progression-Free Survival (PFS) in HGG (Part 2, Stratum A)
Secondary: Evaluate Health-Related Quality of Life Outcomes, Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0, Number of participants with ribociclib and temozolomide-related adverse events as assessed by CTCAE v5.0, Overall Survival in DHG, H3G34-mutant, Overall Survival in HGG
Oncology