Ignite Creation Date:
2024-05-06 @ 2:24 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02034110
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2013-12-05
Brief Title:
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Open-label Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This was a Phase II open-label non-randomized multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer ATC biliary tract cancer BTC gastrointestinal stromal tumor GIST low grade WHO G1G2 glioma LGG high grade WHO G3G4 glioma HGG non-seminomatous germ cell tumors NSGCT non-germinomatous germ cell tumors NGGCT adenocarcinoma of the small intestine ASI hairy cell leukemia HCL and multiple myeloma MM
Detailed Description:
This study was designed to determine the overall response rate ORR of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers Subjects needed to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status Only subjects with histologically confirmed advanced disease and no available standard treatment options were eligible for enrollment Subjects underwent screening assessments within 14 days up to 35 days for ophthalmology exam echocardiogram or disease assessments prior to the start of treatment to determine their eligibility for enrollment in the study All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily Subjects continued treatment until an unacceptable toxicity disease progression withdrawal of consent or death Once a subject discontinued treatment a post-treatment follow-up visit was conducted within 28 days 7 days after the last dose of study treatments Extended follow-up visits were conducted every 4 weeks - 7 days for the first 6 months and then every 3 months - 14 days thereafter A subject was considered to have discontinued the study if the subject was lost to follow-up or withdrew consent or another reason existed that prevented additional data from being collected on the subject A subject was considered to have completed the study at the time of death
For each histology up to 25 patients were planned to be enrolled in each of the 9 primary analysis cohorts A cohort could be closed or stopped early prior to capping at 25 patients for futility or efficacy An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy All planned histology cohorts enrolled at least one subject with the exception of the germ cell tumor cohort Enrolment in the study was closed in July 2018
For each histology up to 25 patients were planned to be enrolled in each of the 9 primary analysis cohorts A cohort could be closed or stopped early prior to capping at 25 patients for futility or efficacy An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy All planned histology cohorts enrolled at least one subject with the exception of the germ cell tumor cohort Enrolment in the study was closed in July 2018
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 |
|---|---|---|---|
| BRF117019 | OTHER | GlaxoSmithKline | None |
| 2013-001705-87 | EUDRACT_NUMBER | None | None |
| CDRB436X2201 | OTHER | None | None |