ANG1005 in Leptomeningeal Disease From Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Angiochem Inc
• Treatments: Capecitabine; Methotrexate; Paclitaxel

Criteria

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