Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT02048059
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old
2. Breast cancer
3. Recurrent brain metastases from breast cancer
4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
5. Neurologically stable
6. Karnofsky Performance Status (KPS) score ≥ 70
7. Adequate hematology and serum chemistry laboratory test results
8. Expected survival of ≥ 3 months
Exclusion Criteria:
1. Prior treatment with ANG1005/GRN1005
2. Evidence of symptomatic intracranial hemorrhage
3. Pregnancy or lactation
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled diseases
6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease
8. Severe cardiac conduction disturbance
9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention
10. Known severe hypersensitivity or allergy to paclitaxel or any of its components
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02048059
Study Brief:
Protocol Section:
NCT02048059