ANG1005 in Leptomeningeal Disease From Breast Cancer (ANGLeD)

April 21, 2023 updated by: Angiochem Inc

A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANG1005
ANG1005 Investigational Drug
Investigational drug
Other Names:
  • paclitaxel trevatide
Active Comparator: 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.
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Other Names:
  • capecitabine
  • eribulin
  • high-dose IV methotrexate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From the date of randomization until death due to any cause, assessed for up to 2 years.
From the date of randomization until death due to any cause, assessed for up to 2 years.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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