ANG1005 in Leptomeningeal Disease From Breast Cancer

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ANG1005 in Leptomeningeal Disease From Breast Cancer

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03613181
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Angiochem Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Leptomeningeal Carcinomatosis, Leptomeningeal Metastases, Brain Metastases, HER2-negative Breast Cancer

Arms & Interventions

Arms

Experimental: ANG1005

ANG1005 Investigational Drug

Active Comparator: Physician's Best Choice

One of the protocol specified Physician's Best Choice therapies, assigned by the Investigator prior to randomization: capecitabine or eribulin or high-dose intravenous (IV) methotrexate.