Back to resultsANG1005 in Leptomeningeal Disease From Breast Cancer (ANGLeD)
Primary Purpose
Leptomeningeal Carcinomatosis, Leptomeningeal Metastases, Brain Metastases
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ANG1005
Physician's Best Choice
Sponsored by
About this trial
This is an interventional treatment trial for Leptomeningeal Carcinomatosis focused on measuring ANG1005, Leptomeningeal carcinomatosis, Leptomeningeal disease, Leptomeningeal metastases, Brain metastases, HER2-negative, Breast cancer, Targeted therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ANG1005
Physician's Best Choice
Arm Description
ANG1005 Investigational Drug
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.
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Central nervous system progression-free survival
Central nervous system clinical benefit rate at 3, 6 and 12 months
6-month and 12-month overall survival rates
Leptomeningeal carcinomatosis response rate
Duration of leptomeningeal carcinomatosis response
Overall survival in triple negative breast cancer patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03613181
Brief Title
ANG1005 in Leptomeningeal Disease From Breast Cancer
Acronym
ANGLeD
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiochem Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to experimental arm and comparator arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANG1005
Arm Type
Experimental
Arm Description
ANG1005 Investigational Drug
Arm Title
Physician's Best Choice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ANG1005
Other Intervention Name(s)
paclitaxel trevatide
Intervention Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
Physician's Best Choice
Other Intervention Name(s)
capecitabine, eribulin, high-dose IV methotrexate.
Intervention Description
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From the date of randomization until death due to any cause, assessed for up to 2 years.
Secondary Outcome Measure Information:
Title
Central nervous system progression-free survival
Time Frame
From the date of randomization until central nervous system progression, assessed for up to 2 years.
Title
Central nervous system clinical benefit rate at 3, 6 and 12 months
Time Frame
At 3, 6 and 12 months.
Title
6-month and 12-month overall survival rates
Time Frame
At 6 and 12 months.
Title
Leptomeningeal carcinomatosis response rate
Time Frame
Assessed for up to 2 years from first patient randomised.
Title
Duration of leptomeningeal carcinomatosis response
Time Frame
Assessed for up to 2 years from first patient randomised.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Huss
Phone
1-514-788-7800
Email
jhuss@angiochem.com
12. IPD Sharing Statement
Learn more about this trial
ANG1005 in Leptomeningeal Disease From Breast Cancer
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