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A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Brain Metastases

Thank you

Trial Information

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases


Please see Brief Summary section.


Key

Inclusion Criteria:



1. Age ≥ 18 years

2. Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR
status must be known)

3. Brain metastasis from breast cancer with or without prior WBRT

4. At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0
cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose
(Metastatic brain lesions previously treated with SRS may not be target or non-target
lesions)

5. Patients must be neurologically stable: 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

6. KPS ≥ 70%

7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose

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 leptomeningeal disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Intra-cranial objective response rate in breast cancer patients with brain metastasis

Outcome Time Frame:

Upon enrollment through end of study period (1 year after last patient is enrolled)

Safety Issue:

No

Principal Investigator

Jean-Paul Castaigne, MD

Investigator Role:

Study Director

Investigator Affiliation:

Angiochem Inc

Authority:

United States: Food and Drug Administration

Study ID:

CP1005B016

NCT ID:

NCT01480583

Start Date:

October 2011

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Brain Metastases
  • GRN1005
  • ANG1005
  • Peptide-Drug Conjugate (PDC)
  • LRP-1
  • Targeted Therapy
  • Breast Cancer
  • Brain Metastases
  • Brain Tumor
  • Blood Brain Barrier
  • Trastuzumab
  • Herceptin
  • Paclitaxel
  • Taxol
  • Breast cancer with brain metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location
Mayo Clinic Rochester, Minnesota  55905
Henry Ford Hospital Detroit, Michigan  48202
Ingalls Memorial Hospital Harvey, Illinois  60426
Mayo Clinic Jacksonville, Florida  32224
Washington Cancer Institute Washington, District of Columbia  20010
City of Hope Duarte, California  91010
Dana Farber Cancer Institute Boston, Massachusetts  02115
Moffitt Cancer Center Tampa, Florida  33612
The West Clinic Memphis, Tennessee  38120
Indiana University Indianapolis, Indiana  46202
University of Southern California Los Angeles, California  90033
Cancer Center of Kansas Wichita, Kansas  67214
MD Anderson Houston, Texas  77230
Tennessee Oncology Nashville, Tennessee  37203
NCI Bethesda, Maryland  20892
University Hospitals Seidman Cancer Center Cleveland, Ohio  44106
Cone Health Cancer Center Greensboro, North Carolina  
Memorial Miller Hospital Long Beach, California  90806
Univ. of California at San Diego La Jolla, California  92093
Univ. Colorado Denver Aurora, Colorado  80045
Georgetown Univ. Washington DC, District of Columbia  20007
Northwest Hematology and Oncology Associates Coral Springs, Florida  33065
Univ. of Miami Miami, Florida  
Northeast Georgia Cancer, LLC Athens, Georgia  30607
Emory Univ. Atlanta, Georgia  30322
Northwestern Univ. Chicago, Illinois  60611
Univ. of North Carolina Chapel Hill, North Carolina  27599
Univ. of Pittsburgh Pittsburgh, Pennsylvania  15232
Neurosurgery PC Great Neck, New York  11021