GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
NCT ID: NCT01497665
Last Updated: 2019-01-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2011-11-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GRN1005 alone
GRN1005 alone
GRN1005
650 mg/m2 IV every 3 weeks
Interventions
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GRN1005
650 mg/m2 IV every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
3. Known intra-cranial hemorrhage
4. Known leptomeningeal disease
18 Years
ALL
No
Sponsors
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Angiochem Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Betty Lawrence
Role: STUDY_DIRECTOR
Angiochem Inc
Patrick Wen, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Univ. of California San Diego
La Jolla, California, United States
Univ. Coloardo at Denver
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwestern Univ.
Chicago, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
McGill Univ.
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CP1005B017
Identifier Type: -
Identifier Source: org_study_id
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