NCT03613181

ANG1005 in Leptomeningeal Disease From Breast Cancer

A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Angiochem Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.

Conditions

• Leptomeningeal Carcinomatosis
• Leptomeningeal Metastases
• Brain Metastases
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	ANG1005	Investigational drug
DRUG	Physician's Best Choice	Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2018-08-03
• Last updated: 2023-04-24

Regulatory

• FDA-regulated drug study