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ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02048059
First Posted: January 29, 2014
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Angiochem Inc
  Purpose
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.

Condition Intervention Phase
Breast Cancer Brain Metastases Drug: ANG1005 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Resource links provided by NLM:


Further study details as provided by Angiochem Inc:

Primary Outcome Measures:
  • Intracranial objective response rate (iORR) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

Secondary Outcome Measures:
  • Duration of intracranial objective response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  • Median intracranial progression free survival (PFS) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  • Intracranial PFS rates at 3, 6 and 12 months [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  • 6-month overall survival rate [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  • Extracranial ORR (eORR) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  • Number of Patients with adverse events [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled ]
  • Pharmacokinetics [ Time Frame: On Day 1 of Cycles 1 and 3 ]
    To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)

  • Duration of Response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
  • Intracranial clinical benefit at 3 and 6 months [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

Enrollment: 72
Study Start Date: April 2014
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANG1005 Drug: ANG1005

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048059


Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
University of California - LAC Medical Center
Los Angeles, California, United States, 90033
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UC - Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Georgia
GRU Cancer Center - Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
National Cancer Institute
Bethesda, Maryland, United States, 20892-1903
United States, Michigan
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
Commack, New York, United States, 11725
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Angiochem Inc
Investigators
Study Director: Betty Lawrence Angiochem Inc
  More Information

Additional Information:
Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT02048059     History of Changes
Other Study ID Numbers: ANG1005-CLN-04
First Submitted: January 21, 2014
First Posted: January 29, 2014
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Angiochem Inc:
ANG1005
GRN1005
Low-density lipoprotein receptor-related protein (LRP-1)
Targeted therapy
Breast cancer
Brain metastases
Brain tumor
Blood-brain barrier
Trastuzumab
Herceptin
Paclitaxel
Taxol
Breast cancer with brain metastases
Triple Negative
Triple negative breast cancer (TNBC)
Herceptin 2 (HER2)-positive
HER2-negative
Metastatic brain tumors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action