Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03433183
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2018-01-29
Brief Title:
SARC031 MEK Inhibitor Selumetinib AZD6244 in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Sarcoma Alliance for Research through Collaboration
Study Overview
Official Title:
SARC031 A Phase 2 Trial of the MEK Inhibitor Selumetinib AZD6244 Hydrogen Sulfate in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors
Status:
COMPLETED
Status Verified Date:
2023-03
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:
To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic neurofibromatosis type 1 NF1 associated or sporadic MPNST
Detailed Description:
I Primary Objective
To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST
II Secondary Objectives
To define and describe the toxicities of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST
To assess the impact on intensity and pain interference and correlate to changes in clinical imaging response and progression
To assess progression free and overall survival
Selumetinib will be given orally 50mg twice daily continuously and sirolimus will be given orally 4mg once daily with a cycle 1 day 1 loading dose of 12mg One cycle will be 28 days Patients will be able to remain on treatment as long as they do not experience progressive disease or unacceptable toxicity Stage 1 will require 7 patients with no further accrual if 0 of 7 respond If 1 or greater of the 7 patients respond accrual will continue until 21 patients have been enrolled
To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST
II Secondary Objectives
To define and describe the toxicities of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST
To assess the impact on intensity and pain interference and correlate to changes in clinical imaging response and progression
To assess progression free and overall survival
Selumetinib will be given orally 50mg twice daily continuously and sirolimus will be given orally 4mg once daily with a cycle 1 day 1 loading dose of 12mg One cycle will be 28 days Patients will be able to remain on treatment as long as they do not experience progressive disease or unacceptable toxicity Stage 1 will require 7 patients with no further accrual if 0 of 7 respond If 1 or greater of the 7 patients respond accrual will continue until 21 patients have been enrolled
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-NF150092 | OTHER_GRANT | Department of Defense | None |