Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03817515
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2022-03-16
First Post:
2019-01-22
Brief Title:
Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation
Sponsor:
Aadi Bioscience Inc
Organization:
Aadi Bioscience Inc
Study Overview
Official Title:
Expanded Access for an Intermediate-size Population for ABI-009 Sirolimus Albumin-bound Nanoparticles for Injectable Suspension in Patients With Advanced Perivascular Epithelioid Cell Tumors PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2022-03
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:
Expanded Access for an Intermediate-size Population for ABI-009 Sirolimus Albumin-bound Nanoparticles for Injectable Suspension in Patients with Advanced Perivascular Epithelioid Cell Tumors PEComa and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation
Detailed Description:
Expanded Access for an Intermediate-size Population for ABI-009 Sirolimus Albumin-bound Nanoparticles for Injectable Suspension in Patients with Advanced Perivascular Epithelioid Cell Tumors PEComa and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation
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