Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843253
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-04-20
Brief Title:
Study of Ribociclib and Everolimus in HGG and DIPG
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
PhaseII Study of Ribociclib and Everolimus Following Radiotherapy in Pediatric and Young Adult Patients Newly Diagnosed With HGG Including DIPG Which Harbor Alterations of the Cell Cycle andor PI3KmTOR Pathways
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma HGG including DIPG that have genetic changes in pathways cell cycle PI3KmTOR that these drugs target
The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG including DIPG
The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG including DIPG
Detailed Description:
This is a multicenter international phase II study of post-radiotherapy RT combination of ribociclib and everolimus to treat pediatric adolescent and young adult patients newly diagnosed with HGG and DIPG that harbor alterations of the cell cycle andor PI3KmTOR pathways to assess treatment efficacy Part 2 The study will include a feasibility cohort Part 1 to identify the dose of ribociclib PfOS Powder for Oral Suspension that is safe and tolerable in combination with everolimus Efficacy for Part 2 study will be defined by progression-free survival PFS HGG stratum A and Overall Survival OS DIPG stratum B with key longitudinal biomarker correlatives Outcomes among patients with primary thalamic spinal cord andor secondary radiation related HGG strata C will be descriptively analyzed Objective radiographic response rates and agent-specific toxicities will also be assessed with a feasibility cohort to determine the recommended phase II dose RP2D of the combination of ribociclib and everolimus in patients with metastatic disease who received upfront craniospinal irradiation stratum D
Protocol therapy with the maintenance combination of ribociclib and everolimus must begin no later than 35 calendar days post-completion of RT The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT Each cycle will be 28 days in duration and treatment can continue up to a total of 26 cycles Ribociclib will be given orally once daily for 3 weeks days 1-21 with one week off Everolimus will be given orally daily continuously days 1-28
Protocol therapy with the maintenance combination of ribociclib and everolimus must begin no later than 35 calendar days post-completion of RT The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT Each cycle will be 28 days in duration and treatment can continue up to a total of 26 cycles Ribociclib will be given orally once daily for 3 weeks days 1-21 with one week off Everolimus will be given orally daily continuously days 1-28
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None