ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Conditions
Breast Cancer - Brain Metastases
Conditions: official terms
Brain Neoplasms - Breast Neoplasms - Neoplasm Metastasis
Conditions: Keywords
ANG1005, GRN1005, LRP-1, Targeted therapy, Breast cancer, Brain metastases, Brain tumor, Blood-brain barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases, Triple Negative, TNBC, HER2-positive, HER2-negative, Metastatic brain tumors
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ANG1005
Type: Drug
Overall Status
Recruiting
Summary
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
Detailed Description
See above.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. ≥ 18 years old

2. Breast cancer

3. Recurrent brain metastases from breast cancer

4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)

5. Neurologically stable

6. Karnofsky Performance Status (KPS) score ≥ 70

Exclusion Criteria:

1. Prior treatment with ANG1005/GRN1005

2. Pregnancy or lactation

3. Inadequate bone marrow reserve

4. Any evidence of severe or uncontrolled diseases

5. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV

6. CNS disease requiring immediate neurosurgery intervention (e.g., resection, shunt placement, etc.)

7. Known allergy to paclitaxel or any of its components
Locations
University of Arizona Cancer Center
Tucson, Arizona, United States
Status: Recruiting
Contact: Crystal Placencia, BS, CCRC - 520-694-1231 - cplacencia@email.arizona.edu
UC San Diego Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
Contact: Peter Clements - 858-822-1847 - pwclements@ucsd.edu
University of California - LAC Medical Center
Los Angeles, California, United States
Status: Active, not recruiting
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
Status: Active, not recruiting
UC - Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
Status: Recruiting
Contact: Janis DeJohn - 877-827-8839 - ucstudy@uci.edu
University of Colorado Cancer Center
Aurora, Colorado, United States
Status: Recruiting
Contact: Lori Fox, RN, BSN, MBA - 720-848-0691 - LORI.FOX@UCDENVER.EDU
GRU Cancer Center - Georgia Regents University
Augusta, Georgia, United States
Status: Recruiting
Contact: Sandra Wall, RN - 706-721-4430 - swall@gru.edu
Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Laurel R Chadde - 312-695-1371 - laurel.chadde@northwestern.edu
Horizon BioAdvance
Lafayette, Indiana, United States
Status: Recruiting
Contact: Beth Morris, RN, OCN, CCRC - 765-446-5111 - emorris@horizonbioadvance.com
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Nancy Tait, RN, BSN, CBCN - 410-328-3546 - ntait@umm.edu
National Cancer Institute
Bethesda, Maryland, United States
Status: Recruiting
Contact: Christine Bryla, RN, MSN - 301-451-7868 - christina.bryla@nih.gov
Westminister Cancer Center
Westminister, Maryland, United States
Status: Withdrawn
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: Ronald Brand - 616-954-5550 - rbrand@chcwm.com
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Neal Wilson, BS - 603-653-0590 - Neal.A.Wilson@hitchcock.org
University of New Mexico
Alburquerque, New Mexico, United States
Status: Recruiting
Contact: Ann Parsons, RN - 505-925-0371 - AParsons@salud.unm.edu
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
Commack, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu, MA, CCRP, CCRC - 516-478-0010 - kprabhu@nspc.com
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Status: Recruiting
Contact: Don Marx - 631-675-5143 - dmarx@NSHOA.com
The Long Island Brain Tumor Center at Neurological Surgery, P.C.
Lake Success, New York, United States
Status: Withdrawn
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Rachel Phipps, RN, BSN, OCN, CBCN - 919-843-7197 - rachel_phipps@med.unc.edu
Gabrail Cancer Center Research
Canton, Ohio, United States
Status: Withdrawn
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Dee Walick, RN, BSN - 216-636-0793 - walickd@ccf.org
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Status: Withdrawn
Hanover Cancer Center
Hanover, Pennsylvania, United States
Status: Withdrawn
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Brenda L Steele, BSN, RN, OCN, CCRC, CBCN - 412-641-2261 - steeleb@upmc.edu
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Brenda L Steele, BSN, RN, OCN, CCRC, CBCN - 412-641-2261 - steeleb@upmc.edu
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Silvia Hodge - 713-563-4525 - shodge@mdanderson.org
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Janie Martinez - 210-450-5715 - MartinezSJ@uthscsa.edu
Start Date
April 2014
Completion Date
October 2016
Sponsors
Angiochem Inc
Source
Angiochem Inc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page