GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/23/2019 |
Start Date: | November 2011 |
End Date: | February 2013 |
A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-Small Cell Lung Cancer Patients With Brain Metastases
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in
patients with brain metastases from non-small cell lung cancer (NSCLC).
patients with brain metastases from non-small cell lung cancer (NSCLC).
Key Inclusion Criteria:
1. Adult patients (≥ 18 years)
2. Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
3. Brain metastases from NSCLC, which:
have radiologically-progressed after WBRT or are present without prior WBRT
4. At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest
diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as
follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed
by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter)
confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is
allowed; however, metastatic brain lesions previously treated with SRS are not allowed
as target or as non-target lesions.
5. Patients must be neurologically stable, defined as being 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 of GRN1005 (Cycle 1,
Day 1).
6. Karnofsky Performance Score (KPS) ≥ 80%
7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005
(with the exception of local radiation therapy for palliation to extra-cranial sites,
i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE
v4.0 Grade 1.0.
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 intra-cranial hemorrhage
4. Known leptomeningeal disease
We found this trial at
10
sites
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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