ANG1005 in Leptomeningeal Disease From Breast Cancer

NCT ID: NCT03613181

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANG1005

ANG1005 Investigational Drug

Group Type: EXPERIMENTAL

ANG1005

Intervention Type: DRUG

Investigational drug

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.

Group Type: ACTIVE_COMPARATOR

Physician's Best Choice

Intervention Type: DRUG

Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.

Interventions

ANG1005

Investigational drug

Intervention Type: DRUG

Physician's Best Choice

Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.

Intervention Type: DRUG

Other Intervention Names

paclitaxel trevatide; capecitabine; eribulin; high-dose IV methotrexate.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiochem Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

John Huss

Role: CONTACT

jhuss@angiochem.com

1-514-788-7800

Other Identifiers

ANG1005-CLN-07

Identifier Type: -

Identifier Source: org_study_id