ANG1005 in Leptomeningeal Disease From Breast Cancer

Last updated: April 21, 2023
Sponsor: Angiochem Inc
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Brain Metastases

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT03613181
ANG1005-CLN-07
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 radiationtherapy
  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 ofbirth control

Exclusion

Exclusion Criteria:

  1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapyor 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 forleptomeningeal 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 withhepatitis 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

Study Design

Total Participants: 150
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2024