- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613181
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
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
- Name: John Huss
- Phone Number: 1-514-788-7800
- Email: jhuss@angiochem.com
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:
- ≥ 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
Exclusion Criteria:
- 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
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:
|
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:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Meningeal Neoplasms
- Breast Neoplasms
- Carcinoma
- Neoplasm Metastasis
- Brain Neoplasms
- Neoplasms, Second Primary
- Meningeal Carcinomatosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Paclitaxel
- Capecitabine
- Methotrexate
Other Study ID Numbers
- ANG1005-CLN-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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