Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03224767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2017-07-19
Brief Title:
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of BRAFMEK Inhibitors in Papillary Craniopharyngiomas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment
II To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment
SECONDARY OBJECTIVES
I To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
II To determine the toxicity of BRAFMEK inhibitors in patients with papillary craniopharyngiomas
III To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma
IV To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma
V To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
VI To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
TERTIARY OBJECTIVES
I To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
II To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
III To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
IV To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
V To evaluate molecular biomarkers of response in papillary craniopharyngiomas
VI To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid DNA in patients with papillary craniopharyngiomas
OUTLINE
Patients receive vemurafenib orally PO twice daily BID on day 1-28 and cobimetinib PO once daily QD on days 1-21 Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity Patients may then receive radiation therapy surgery or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician
After completion of study treatment patients with disease progression are followed up every 16 weeks for 2 years and all other patients are followed up every 6 months for 5 years
I To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment
II To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment
SECONDARY OBJECTIVES
I To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
II To determine the toxicity of BRAFMEK inhibitors in patients with papillary craniopharyngiomas
III To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma
IV To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma
V To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
VI To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
TERTIARY OBJECTIVES
I To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
II To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
III To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors
IV To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAFMEK inhibitors
V To evaluate molecular biomarkers of response in papillary craniopharyngiomas
VI To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid DNA in patients with papillary craniopharyngiomas
OUTLINE
Patients receive vemurafenib orally PO twice daily BID on day 1-28 and cobimetinib PO once daily QD on days 1-21 Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity Patients may then receive radiation therapy surgery or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician
After completion of study treatment patients with disease progression are followed up every 16 weeks for 2 years and all other patients are followed up every 6 months for 5 years
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 |
|---|---|---|---|
| U10CA180821 | NIH | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA180821 |
| NCI-2017-00740 | REGISTRY | None | None |