Brain Metastases, Breast Cancer
Conditions
Keywords
ANG1005, GRN1005, Low-density lipoprotein receptor-related protein (LRP-1), Targeted therapy, Breast cancer, Brain metastases, Brain tumor, Blood-brain barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases, Triple Negative, Triple negative breast cancer (TNBC), Herceptin 2 (HER2)-positive, HER2-negative, Metastatic brain tumors
Brief summary
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
Interventions
DRUGANG1005
Sponsors
Angiochem Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate (iORR) | Upon enrollment through end of study period (1 year after last patient is enrolled) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median intracranial progression-free survival (PFS) | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| Intracranial PFS rates at 3, 6 and 12 months | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| 6-month overall survival (OS) rate | Upon enrollment through end of study period (1 year after last patient is enrolled | — |
| Extracranial objective response rate (eORR) and duration of response | Upon enrollment through end of study period (1 year after last patient is enrolled | — |
| Duration of intracranial objective response | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| Plasma pharmacokinetics of ANG1005 | On Day 1 of Cycles 1 and 3 | To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2) |
| Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| Intracranial clinical benefit rate (iCBR) at 3 and 6 months | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| Potential immunogenicity of ANG1005 | Upon enrollment through end of study period (1 year after last patient is enrolled) | — |
| Number of Patients with adverse events | Upon enrollment through end of study period (1 year after last patient is enrolled | — |
Countries
United States
Outcome results
None listed