Back to resultsGRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L) (GRABM-L)
Primary Purpose
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GRN1005
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) With Brain Metastases focused on measuring GRN1005, ANG1005, LRP-1, Targeted Therapy, Brain Tumor, Blood Brain Barrier, Peptide-Drug Conjugate (PDC), Brain Metastases, Paclitaxel, Taxol, NSCLC, Non-Small Cell Lung Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Adult patients (≥ 18 years)
- Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
Brain metastases from NSCLC, which:
have radiologically-progressed after WBRT or are present without prior WBRT
- 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.
- 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).
- Karnofsky Performance Score (KPS) ≥ 80%
- 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:
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known intra-cranial hemorrhage
- Known leptomeningeal disease
Sites / Locations
- Univ. of California San Diego
- Univ. Coloardo at Denver
- H. Lee Moffitt Cancer Center
- Northwestern Univ.
- Ingalls Memorial Hospital
- Dana Farber Cancer Institute
- Karmanos Cancer Institute
- Univ. of Pittsburgh Medical Center
- Tennessee Oncology
- McGill Univ.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GRN1005 alone
Arm Description
GRN1005 alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Duration of Overall Objective Response
Duration of Overall Progression Free Survival
Six Month Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01497665
Brief Title
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
Acronym
GRABM-L
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiochem Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Keywords
GRN1005, ANG1005, LRP-1, Targeted Therapy, Brain Tumor, Blood Brain Barrier, Peptide-Drug Conjugate (PDC), Brain Metastases, Paclitaxel, Taxol, NSCLC, Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRN1005 alone
Arm Type
Experimental
Arm Description
GRN1005 alone
Intervention Type
Drug
Intervention Name(s)
GRN1005
Other Intervention Name(s)
ANG1005
Intervention Description
650 mg/m2 IV every 3 weeks
Primary Outcome Measure Information:
Title
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis
Description
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.
Time Frame
upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Duration of Overall Objective Response
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Duration of Overall Progression Free Survival
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Six Month Overall Survival
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Adult patients (≥ 18 years)
Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
Brain metastases from NSCLC, which:
have radiologically-progressed after WBRT or are present without prior WBRT
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.
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).
Karnofsky Performance Score (KPS) ≥ 80%
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:
NCI CTCAE v4.0 Grade ≥ 2 neuropathy
CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
Known intra-cranial hemorrhage
Known leptomeningeal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Lawrence
Organizational Affiliation
Angiochem Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patrick Wen, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ. of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Univ. Coloardo at Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Univ.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ. of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
McGill Univ.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
12. IPD Sharing Statement
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GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
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