Clinical trial NCT03613181: ANG1005 in Leptomeningeal Disease From Breast Cancer
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
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: Angiochem Inc
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to experimental arm and comparator arm
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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