Status:
COMPLETED
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
Lead Sponsor:
Angiochem Inc
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Detailed Description
Please see Brief Summary section.
Eligibility Criteria
Inclusion
- Key
- Age ≥ 18 years
- Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
- Brain metastasis from breast cancer with or without prior WBRT
- 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)
- 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
- KPS ≥ 70%
- Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose
- Key
Exclusion
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01480583
Start Date
October 1 2011
End Date
October 1 2015
Last Update
July 13 2016
Active Locations (2)
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1
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
2
NCI
Rockville, Maryland, United States, 20892