Last updated: April 21, 2023
Sponsor: Angiochem Inc
Overall Status: Active - Not Recruiting
Phase
3
Condition
Carcinoma
Brain Metastases
Neoplasm Metastasis
Treatment
N/AClinical Study ID
NCT03613181
ANG1005-CLN-07
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥ 18 years old
- HER2-negative breast cancer
- At least 2 months of expected survival
- Newly diagnosed leptomeningeal carcinomatosis
- Documented history of brain metastasis that has been previously treated with radiationtherapy
- Neurologically stable
- Eastern Cooperative Oncology Group performance status grade ≤2
- Adequate laboratory test results prior to first dose
- Patients who are fertile must agree to remain abstinent or use reliable method ofbirth control
Exclusion
Exclusion Criteria:
- Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapyor shunt
- Prior treatment with ANG1005
- Patients who have not had radiotherapy for their brain metastases
- Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
- Patients for whom intrathecal therapy is the most appropriate therapy forleptomeningeal disease
- Pregnancy or lactation and patients planning to be pregnant during the study
- Peripheral neuropathy > Grade 2
- Evidence of severe or uncontrolled diseases
- Presence of an infection including abscess or fistulae, or known infection withhepatitis B or C or HIV
- History of interstitial lung disease
- Severe conduction disturbance
- Central nervous system disease requiring immediate neurosurgical intervention
- Known allergy to paclitaxel or any of its components
- Contra-indication for contrast-enhanced MRI
Study Design
Total Participants: 150
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2024