ANG1005 in Leptomeningeal Disease From Breast Cancer

NCT03613181 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: ANG1005-CLN-07
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Keywords

ANG1005; Leptomeningeal carcinomatosis; Leptomeningeal disease; Leptomeningeal metastases; Brain metastases; HER2-negative; Breast cancer; Targeted therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

Secondary Outcomes (6)

• Central nervous system progression-free survival

  From the date of randomization until central nervous system progression, assessed for up to 2 years.

• Central nervous system clinical benefit rate at 3, 6 and 12 months

  At 3, 6 and 12 months.

• 6-month and 12-month overall survival rates

  At 6 and 12 months.

• 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.

Study Arms (2)

ANG1005

EXPERIMENTAL

ANG1005 Investigational Drug

Drug: ANG1005

Physician's Best Choice

ACTIVE COMPARATOR

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.

Drug: Physician's Best Choice

Interventions

ANG1005 DRUG

Investigational drug

Also known as: paclitaxel trevatide

ANG1005

Physician's Best Choice DRUG

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

Also known as: capecitabine, eribulin, high-dose IV methotrexate.

Physician's Best Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• Patients who are fertile must agree to remain abstinent or use reliable method of birth control

You may not qualify if:

• 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
• Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
• History of interstitial lung disease
• Severe conduction disturbance
• Central nervous system disease requiring immediate neurosurgical intervention
• Known allergy to paclitaxel or any of its components
• Contra-indication for contrast-enhanced MRI

Sponsors & Collaborators

• Angiochem Inc: lead

MeSH Terms

Conditions

Meningeal Carcinomatosis; Brain Neoplasms; Meningeal Neoplasms; Breast Neoplasms

Interventions

paclitaxel-Angiopep-2 conjugate; Capecitabine; eribulin; Methotrexate

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

John Huss

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to experimental arm and comparator arm

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 3, 2018
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04