ANG1005 in Leptomeningeal Disease From Breast Cancer (ANGLeD)

Angiochem

Status and phase: Not yet enrolling; Phase 3

Conditions: Brain Metastases; Leptomeningeal Carcinomatosis; HER2-negative Breast Cancer; Leptomeningeal Metastases

Treatments: Drug: Physician's Best Choice; Drug: ANG1005

Study type: Interventional

Funder types: Industry

Identifiers

NCT03613181

ANG1005-CLN-07

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

ANG1005

Experimental group

Description:

ANG1005 Investigational Drug

Treatment:

Drug: ANG1005

Physician's Best Choice

Active Comparator group

Description:

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.

Treatment:

Drug: Physician's Best Choice