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ANG1005 in Leptomeningeal Disease From Breast Cancer | Clinical Trials | Clareo Health

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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)

NCT03613181•Angiochem Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 18 years old
•2. HER2-negative breast cancer
•3. At least 2 months of expected survival
•4. Newly diagnosed leptomeningeal carcinomatosis
•5. Documented history of brain metastasis that has been previously treated with radiation therapy
•6. Neurologically stable
•7. Eastern Cooperative Oncology Group performance status grade ≤2
•8. Adequate laboratory test results prior to first dose
•9. Patients who are fertile must agree to remain abstinent or use reliable method of birth control

Exclusion Criteria

•1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
•2. Prior treatment with ANG1005
•3. Patients who have not had radiotherapy for their brain metastases
•4. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
•5. Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease
•6. Pregnancy or lactation and patients planning to be pregnant during the study
•7. Peripheral neuropathy \> Grade 2
•8. Evidence of severe or uncontrolled diseases
•9. Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
•10. History of interstitial lung disease
+4 more criteria

Key Dates

Start Date

December 1, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

April 24, 2023

Enrollment

150

ESTIMATED participants

Conditions

Leptomeningeal CarcinomatosisLeptomeningeal MetastasesBrain MetastasesHER2-negative Breast Cancer

Interventions

ANG1005

DRUG

Physician's Best Choice

DRUG

Contacts

John Huss

CONTACT

1-514-788-7800 jhuss@angiochem.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ANG1005 in Leptomeningeal Disease From Breast Cancer

Inclusion Criteria

Exclusion Criteria

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