Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02684058
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2016-02-04
Brief Title:
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma LGG or Relapsed or Refractory High Grade Glioma HGG
Status:
COMPLETED
Status Verified Date:
2023-11
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 purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma LGG or relapsed or refractory high grade glioma HGG
Detailed Description:
This study combines two pediatric glioma cohorts LGG and HGG cohorts into a multi-center open-label Phase II study
The LGG cohort is a multi-center randomized open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive LGG whose tumor was unresectable and who required first systemic treatment Participants in the LGG cohort were randomized in a 21 ratio to either dabrafenib plus trametinib or carboplatin with vincristine
The HGG cohort is a multi-center single-arm open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive refractory or relapsed HGG tumors after having received at least one previous standard therapy
The duration of treatment for participants on dabrafenib plus trametinib in LGG and for all patients in the HGG cohort was continued until the loss of clinical benefit in the opinion of the Investigator unacceptable toxicity start of a new anti-neoplastic therapy discontinuation at the discretion of the investigator or patientlegal guardian lost to follow-up death study termination by the sponsor or until disease progression The duration of treatment for patients in the carboplatin with vincristine arm in LGG cohort was continued for the prescribed number of cycles as tolerated or until unacceptable toxicity start of a new anti-neoplastic therapy discontinuation at the discretion of the investigator or patientlegal guardian lost to follow-up death study is terminated by the sponsor or until disease progression Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross over to receive dabrafenib in combination with trametinib after centrally confirmed RANO-defined disease progression Crossover was allowed during the treatment period or the post-treatment period
After discontinuation of study treatment all participants LGG and HGG cohorts were followed for safety for at least 30 days after the last dose of study treatment All participants who discontinued study treatment for reasons other than disease progression death loss to follow up or withdrawal of consent moved into the post-treatment efficacy follow-up phase Finally all participants were followed for survival once they discontinued study treatment for at least 2 years after the last patient first study treatment except if consent was withdrawn death or the patient was lost to follow-up or discontinued study
The LGG cohort is a multi-center randomized open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive LGG whose tumor was unresectable and who required first systemic treatment Participants in the LGG cohort were randomized in a 21 ratio to either dabrafenib plus trametinib or carboplatin with vincristine
The HGG cohort is a multi-center single-arm open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive refractory or relapsed HGG tumors after having received at least one previous standard therapy
The duration of treatment for participants on dabrafenib plus trametinib in LGG and for all patients in the HGG cohort was continued until the loss of clinical benefit in the opinion of the Investigator unacceptable toxicity start of a new anti-neoplastic therapy discontinuation at the discretion of the investigator or patientlegal guardian lost to follow-up death study termination by the sponsor or until disease progression The duration of treatment for patients in the carboplatin with vincristine arm in LGG cohort was continued for the prescribed number of cycles as tolerated or until unacceptable toxicity start of a new anti-neoplastic therapy discontinuation at the discretion of the investigator or patientlegal guardian lost to follow-up death study is terminated by the sponsor or until disease progression Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross over to receive dabrafenib in combination with trametinib after centrally confirmed RANO-defined disease progression Crossover was allowed during the treatment period or the post-treatment period
After discontinuation of study treatment all participants LGG and HGG cohorts were followed for safety for at least 30 days after the last dose of study treatment All participants who discontinued study treatment for reasons other than disease progression death loss to follow up or withdrawal of consent moved into the post-treatment efficacy follow-up phase Finally all participants were followed for survival once they discontinued study treatment for at least 2 years after the last patient first study treatment except if consent was withdrawn death or the patient was lost to follow-up or discontinued study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-004015-20 | EUDRACT_NUMBER | None | None |