Brain Metastases, Breast Cancer
Conditions
Keywords
GRN1005, ANG1005, Peptide-Drug Conjugate (PDC), LRP-1, Targeted Therapy, Breast Cancer, Brain Metastases, Brain Tumor, Blood Brain Barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases
Brief summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice. In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).
Detailed description
Please see Brief Summary section.
Interventions
Sponsors
Angiochem Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known) 3. Brain metastasis from breast cancer with or without prior WBRT 4. At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain \< 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions) 5. Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose 6. KPS ≥ 70% 7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose Key
Exclusion criteria
1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy 2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.) 3. Known leptomeningeal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra-cranial objective response rate in breast cancer patients with brain metastasis | Upon enrollment through end of study period (1 year after last patient is enrolled) |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Intra-cranial objective response duration | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| 3-month intra-cranial progression-free survival | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Six month overall survival (OS) | Upon enrollment through end of study period (1 year after last patient is enrolled) |
Countries
United States
Outcome results
None listed