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GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)

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

NCT01497665•Angiochem Inc

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (10)

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

Key Dates

Start Date

November 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

February 1, 2013

Last Updated

January 22, 2019

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer (NSCLC) With Brain Metastases

Interventions

GRN1005

DRUG