Non-small Cell Lung Cancer (NSCLC) With Brain Metastases Clinical Trial
— GRABM-LOfficial title:
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
| Verified date | January 2019 |
| Source | Angiochem Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | February 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | McGill Univ. | Montreal | Quebec |
| United States | Univ. Coloardo at Denver | Aurora | Colorado |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Northwestern Univ. | Chicago | Illinois |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Ingalls Memorial Hospital | Harvey | Illinois |
| United States | Univ. of California San Diego | La Jolla | California |
| United States | Tennessee Oncology | Nashville | Tennessee |
| United States | Univ. of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Angiochem Inc |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis | Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR. | upon enrollment through end of study period (1 year after last patient is enrolled) | |
| Secondary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Upon enrollment through end of study period (1 year after last patient is enrolled) | ||
| Secondary | Duration of Overall Objective Response | Upon enrollment through end of study period (1 year after last patient is enrolled) | ||
| Secondary | Duration of Overall Progression Free Survival | Upon enrollment through end of study period (1 year after last patient is enrolled) | ||
| Secondary | Six Month Overall Survival | Upon enrollment through end of study period (1 year after last patient is enrolled) |