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

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01497665
First received: December 20, 2011
Last updated: March 8, 2016
Last verified: March 2016

December 20, 2011
March 8, 2016
November 2011
January 2013   (final data collection date for primary outcome measure)
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis [ Time Frame: upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
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.
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis [ Time Frame: upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01497665 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: Yes ]
  • Duration of Overall Objective Response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
  • Duration of Overall Progression Free Survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
  • Six Month Overall Survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Drug: GRN1005
650 mg/m2 IV every 3 weeks
Other Name: ANG1005
Experimental: GRN1005 alone
GRN1005 alone
Intervention: Drug: GRN1005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
February 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01497665
CP1005B017
Yes
Not Provided
Not Provided
Angiochem Inc
Angiochem Inc
Not Provided
Study Director: Betty Lawrence Angiochem Inc
Principal Investigator: Patrick Wen, MD Dana-Farber Cancer Institute
Angiochem Inc
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP