NCT03463265

Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

A Phase 2, Open-label Study of ABI-009 (Nab-Rapamycin) in Patients With Recurrent High-grade Glioma and Patients With Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Aadi Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.

Detailed description

A phase 2, open-label study of nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies, including temozolomide, bevacizumab, lomustine, and marizomib.

Conditions

• High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma

Interventions

Type	Name	Description
DRUG	nab-sirolimus	nab-sirolimus, single agent
DRUG	nab-sirolimus + temozolomide	temozolomide, combination
DRUG	nab-sirolimus + bevacizumab	bevacizumab, combination
DRUG	nab-sirolimus + lomustine	lomustine, combination
DRUG	nab-sirolimus + marizomib (MRZ)	marizomib (MRZ), combination
DRUG	nab-sirolimus + temozolomide + radiotherapy	temozolomide + radiotherapy, combination

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2018-03-13
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study