ANG1005 in Leptomeningeal Disease From Breast Cancer

Phase 3

Not yet recruiting

• Conditions: HER2-negative Breast Cancer; Leptomeningeal Carcinomatosis; Leptomeningeal Metastases; Brain Metastases
• Interventions: Drug: Physician's Best Choice; Drug: ANG1005

• Registration Number: NCT03613181
• Lead Sponsor: Angiochem Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician's Best Choice	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.
ANG1005	ANG1005	ANG1005 Investigational Drug

Primary Outcome Measures

Name	Time	Method
Overall survival	From the date of randomization until death due to any cause, assessed for up to 2 years.

Secondary Outcome Measures

Name	Time	Method
6-month and 12-month overall survival rates	At 6 and 12 months.
Overall survival in triple negative breast cancer patients	From the date of randomization until death due to any cause, assessed for up to 2 years.
Leptomeningeal carcinomatosis response rate	Assessed for up to 2 years from first patient randomised.
Duration of leptomeningeal carcinomatosis response	Assessed for up to 2 years from first patient randomised.
Central nervous system clinical benefit rate at 3, 6 and 12 months	At 3, 6 and 12 months.
Central nervous system progression-free survival	From the date of randomization until central nervous system progression, assessed for up to 2 years.