UnknownPhase 3

ANG1005 in Leptomeningeal Disease From Breast Cancer

150 participantsStarted 2023-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 radiation therapy
✓. Neurologically stable
✓. Eastern Cooperative Oncology Group performance status grade ≤2
✓. Adequate laboratory test results prior to first dose

Exclusion criteria

✕. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or 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 for leptomeningeal disease
✕. Pregnancy or lactation and patients planning to be pregnant during the study
✕. Peripheral neuropathy \> Grade 2
✕. Evidence of severe or uncontrolled diseases

What they're measuring

Overall survival

Timeframe: From the date of randomization until death due to any cause, assessed for up to 2 years.

Trial details

NCT IDNCT03613181

SponsorAngiochem Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

John Huss

1-514-788-7800 jhuss@angiochem.com

View on ClinicalTrials.gov More Leptomeningeal Carcinomatosis trials