ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
NCT ID: NCT02048059
Last Updated: 2020-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2014-04-30
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ANG1005 in Leptomeningeal Disease From Breast Cancer
NCT03613181
Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
NCT01086605
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
NCT00010075
A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer
NCT00051051
Chemotherapeutic Agents in Brain/Breast
NCT00795678
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ANG1005
Participants 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.
ANG1005
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ANG1005
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
7. Adequate hematology and serum chemistry laboratory test results
8. Expected survival of ≥ 3 months
Exclusion Criteria
2. Evidence of symptomatic intracranial hemorrhage
3. Pregnancy or lactation
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled diseases
6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease
8. Severe cardiac conduction disturbance
9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention
10. Known severe hypersensitivity or allergy to paclitaxel or any of its components
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Angiochem Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Betty Lawrence
Role: STUDY_DIRECTOR
Angiochem Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona Cancer Center
Tucson, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California - LAC Medical Center
Los Angeles, California, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC - Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
GRU Cancer Center - Georgia Regents University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
Commack, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumors
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANG1005-CLN-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.