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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01497665
First received: December 20, 2011
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Drug: GRN1005
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Angiochem Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRN1005 alone
GRN1005 alone
Drug: GRN1005
650 mg/m2 IV every 3 weeks
Other Name: ANG1005

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497665

Locations
United States, California
Univ. of California San Diego
La Jolla, California, United States, 92093
United States, Colorado
Univ. Coloardo at Denver
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Univ.
Chicago, Illinois, United States, 60611
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Canada, Quebec
McGill Univ.
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Angiochem Inc
Investigators
Study Director: Jean-Paul Castaigne, MD Angiochem Inc
Principal Investigator: Patrick Wen, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT01497665     History of Changes
Other Study ID Numbers: CP1005B017
Study First Received: December 20, 2011
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiochem Inc:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014