Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528691
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Entrectinib as a Single Agent in Upfront Therapy for Children 3 Years of Age With NTRK123 or ROS1-FUSED CNS Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children 3 Years of Age With NTRK123 or ROS1-FUSED CNS Tumors GLOBOTRK
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 123 or ROS1 fused high grade glioma or other central nervous system CNS tumors
Detailed Description:
PRIMARY OBJECTIVE
To determine the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK123- or ROS1-fused high-grade glioma HGG Cohort 1
SECONDARY OBJECTIVES
To estimate the 2-year and 5-year progression free survival PFS and overall survival OS in patients who are younger than 3 years of age with NTRK123- or ROS1-fused HGG treated with entrectinib as first line therapy Cohort 1
To estimate the duration of response DOR in patients who are younger than 3 years of age with NTRK123- or ROS1-fused HGG treated with entrectinib as first line therapy Cohort 1
To evaluate the fraction of patients with NTRK123- or ROS1-fused HGG treated who have second surgeries and a gross-total resection after treatment with entrectinib is achieved overall and by country and hospital Cohort 1
To describe the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG Cohort 2
To estimate the 2-year and 5-year PFS and OS in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG treated with entrectinib as first line therapy Cohort 2
To estimate the duration of response DOR in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG treated with entrectinib as first line therapy Cohort 2
To evaluate the fraction of patients with NTRK123- or ROS1-fused CNS tumors other than HGG who have second surgeries and a gross-total resection after treatment with entrectinib is achieved overall and by country and hospital Cohort 2
To describe toxicities experienced by patients younger than 3 years of age treated with entrectinib Cohort 1 and 2
To evaluate number of patients that are screened for the study and eligible versus enrolled and treated with entrectinib Cohort 1 and 2
To measure the time intervals days from time of initial diagnostic surgery to screening and enrollment in this study Cohort 1 and 2
The trial will have 2 cohorts Cohort 1 patients diagnosed with NTRK123- or ROS1-fused high-grade glioma HGG and Cohort 2 patients diagnosed with NTRK123- or ROS1-fused CNS tumors other than HGG
Patients receive entrectinib enterally once daily QD on days 1-28 of each cycle Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients requiring bridging therapy prior to starting entrectinib may receive cyclophosphamide intravenously IV over 1 hour on day 1 etoposide IV over 1 hour on day 1 and 2 carboplatin IV over 1 hour on day 2 filgrastim subcutaneously SC or IV or pegfilgrastim SC on day 3
A gross total resection or significant debulking may become possible if a response to entrectinib is seen If surgical resection is performed and a gross total resection is achieved 24 cycles of entrectinib will be completed including those before and after surgery
After treatment patients will be followed for 5 years
To determine the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK123- or ROS1-fused high-grade glioma HGG Cohort 1
SECONDARY OBJECTIVES
To estimate the 2-year and 5-year progression free survival PFS and overall survival OS in patients who are younger than 3 years of age with NTRK123- or ROS1-fused HGG treated with entrectinib as first line therapy Cohort 1
To estimate the duration of response DOR in patients who are younger than 3 years of age with NTRK123- or ROS1-fused HGG treated with entrectinib as first line therapy Cohort 1
To evaluate the fraction of patients with NTRK123- or ROS1-fused HGG treated who have second surgeries and a gross-total resection after treatment with entrectinib is achieved overall and by country and hospital Cohort 1
To describe the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG Cohort 2
To estimate the 2-year and 5-year PFS and OS in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG treated with entrectinib as first line therapy Cohort 2
To estimate the duration of response DOR in patients who are younger than 3 years of age with NTRK123- or ROS1-fused CNS tumors other than HGG treated with entrectinib as first line therapy Cohort 2
To evaluate the fraction of patients with NTRK123- or ROS1-fused CNS tumors other than HGG who have second surgeries and a gross-total resection after treatment with entrectinib is achieved overall and by country and hospital Cohort 2
To describe toxicities experienced by patients younger than 3 years of age treated with entrectinib Cohort 1 and 2
To evaluate number of patients that are screened for the study and eligible versus enrolled and treated with entrectinib Cohort 1 and 2
To measure the time intervals days from time of initial diagnostic surgery to screening and enrollment in this study Cohort 1 and 2
The trial will have 2 cohorts Cohort 1 patients diagnosed with NTRK123- or ROS1-fused high-grade glioma HGG and Cohort 2 patients diagnosed with NTRK123- or ROS1-fused CNS tumors other than HGG
Patients receive entrectinib enterally once daily QD on days 1-28 of each cycle Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients requiring bridging therapy prior to starting entrectinib may receive cyclophosphamide intravenously IV over 1 hour on day 1 etoposide IV over 1 hour on day 1 and 2 carboplatin IV over 1 hour on day 2 filgrastim subcutaneously SC or IV or pegfilgrastim SC on day 3
A gross total resection or significant debulking may become possible if a response to entrectinib is seen If surgical resection is performed and a gross total resection is achieved 24 cycles of entrectinib will be completed including those before and after surgery
After treatment patients will be followed for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None