Brain Metastases, HER2-negative Breast Cancer, Leptomeningeal Carcinomatosis, Leptomeningeal Metastases
Conditions
Keywords
ANG1005, Leptomeningeal carcinomatosis, Leptomeningeal disease, Leptomeningeal metastases, Brain metastases, HER2-negative, Breast cancer, Targeted therapy
Brief 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.
Interventions
DRUGANG1005
Investigational drug
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Sponsors
Angiochem Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization to experimental arm and comparator arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | From the date of randomization until death due to any cause, assessed for up to 2 years. |
Secondary
| Measure | Time frame |
|---|---|
| Central nervous system clinical benefit rate at 3, 6 and 12 months | At 3, 6 and 12 months. |
| 6-month and 12-month overall survival rates | At 6 and 12 months. |
| Central nervous system progression-free survival | From the date of randomization until central nervous system progression, assessed for up to 2 years. |
| Duration of leptomeningeal carcinomatosis response | Assessed for up to 2 years from first patient randomised. |
| 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. |
| Leptomeningeal carcinomatosis response rate | Assessed for up to 2 years from first patient randomised. |
Contacts
Primary ContactJohn Huss
Outcome results
None listed