ANG1005 in Leptomeningeal Disease From Breast Cancer

Brain Metastases Clinical Trial

— ANGLeD  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613181
• Other study ID #: ANG1005-CLN-07
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Angiochem Inc
• Contact: John Huss
• Phone: 1-514-788-7800
• Email: jhuss[@]angiochem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

11. Severe conduction disturbance

12. Central nervous system disease requiring immediate neurosurgical intervention

13. Known allergy to paclitaxel or any of its components

14. Contra-indication for contrast-enhanced MRI

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Neoplasms
• Carcinoma
• HER2-negative Breast Cancer
• Leptomeningeal Carcinomatosis
• Leptomeningeal Metastases
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Angiochem Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From the date of randomization until death due to any cause, assessed for up to 2 years.
Secondary	Central nervous system progression-free survival		From the date of randomization until central nervous system progression, assessed for up to 2 years.
Secondary	Central nervous system clinical benefit rate at 3, 6 and 12 months		At 3, 6 and 12 months.
Secondary	6-month and 12-month overall survival rates		At 6 and 12 months.
Secondary	Leptomeningeal carcinomatosis response rate		Assessed for up to 2 years from first patient randomised.
Secondary	Duration of leptomeningeal carcinomatosis response		Assessed for up to 2 years from first patient randomised.
Secondary	Overall survival in triple negative breast cancer patients		From the date of randomization until death due to any cause, assessed for up to 2 years.