ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
1 other identifier
interventional
72
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Apr 2014
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 25, 2020
February 1, 2020
1.9 years
January 21, 2014
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracranial objective response rate (iORR)
Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Outcomes (10)
Duration of intracranial objective response
Upon enrollment through end of study period (1 year after last patient is enrolled)
Median intracranial progression-free survival (PFS)
Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months
Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate
Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response
Upon enrollment through end of study period (1 year after last patient is enrolled
- +5 more secondary outcomes
Study Arms (1)
ANG1005
EXPERIMENTALParticipants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- Breast cancer
- Recurrent brain metastases from breast cancer
- At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
- Neurologically stable
- Karnofsky Performance Status (KPS) score ≥ 70
- Adequate hematology and serum chemistry laboratory test results
- Expected survival of ≥ 3 months
You may not qualify if:
- Prior treatment with ANG1005/GRN1005
- Evidence of symptomatic intracranial hemorrhage
- Pregnancy or lactation
- Inadequate bone marrow reserve
- Any evidence of severe or uncontrolled diseases
- Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
- History of interstitial lung disease or evidence of clinically significant interstitial lung disease
- Severe cardiac conduction disturbance
- Central nervous system (CNS) disease requiring immediate neurosurgery intervention
- Known severe hypersensitivity or allergy to paclitaxel or any of its components
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angiochem Inclead
Study Sites (19)
University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
University of California - LAC Medical Center
Los Angeles, California, 90033, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC - Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
GRU Cancer Center - Georgia Regents University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
National Cancer Institute
Bethesda, Maryland, 20892-1903, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
Commack, New York, 11725, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Betty Lawrence
Angiochem Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 29, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2016
Study Completion
September 1, 2017
Last Updated
February 25, 2020
Record last verified: 2020-02