Back to resultsANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Primary Purpose
Breast Cancer, Brain Metastases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ANG1005
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Arizona Cancer Center
- UC San Diego Moores Cancer Center
- University of California - LAC Medical Center
- University of Southern California - Norris Comprehensive Cancer Center
- UC - Irvine Chao Family Comprehensive Cancer Center
- University of Colorado Cancer Center
- GRU Cancer Center - Georgia Regents University
- Northwestern University
- University of Maryland - Greenebaum Cancer Center
- National Cancer Institute
- Cancer & Hematology Centers of Western Michigan
- University of New Mexico
- The Long Islan Brain Tumor Center at Neurological Surgery P.C.
- University of North Carolina at Chapel Hill
- Cleveland Clinic
- Magee Womens Hospital
- UPMC Cancer Center
- MD Anderson Cancer Center
- Univeristy of Texas Health Science Center in San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ANG1005
Arm Description
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.
Outcomes
Primary Outcome Measures
Intracranial objective response rate (iORR)
Secondary Outcome Measures
Duration of intracranial objective response
Median intracranial progression-free survival (PFS)
Intracranial PFS rates at 3, 6 and 12 months
6-month overall survival (OS) rate
Extracranial objective response rate (eORR) and duration of response
Number of Patients with adverse events
Plasma pharmacokinetics of ANG1005
To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
Intracranial clinical benefit rate (iCBR) at 3 and 6 months
Potential immunogenicity of ANG1005
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02048059
Brief Title
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Official Title
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiochem Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Brain Metastases
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ANG1005
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ANG1005
Primary Outcome Measure Information:
Title
Intracranial objective response rate (iORR)
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Outcome Measure Information:
Title
Duration of intracranial objective response
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Median intracranial progression-free survival (PFS)
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
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)
Title
6-month overall survival (OS) rate
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled
Title
Extracranial objective response rate (eORR) and duration of response
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled
Title
Number of Patients with adverse events
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled
Title
Plasma pharmacokinetics of ANG1005
Description
To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Time Frame
On Day 1 of Cycles 1 and 3
Title
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Intracranial clinical benefit rate (iCBR) at 3 and 6 months
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
Title
Potential immunogenicity of ANG1005
Time Frame
Upon enrollment through end of study period (1 year after last patient is enrolled)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Lawrence
Organizational Affiliation
Angiochem Inc
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
University of California - LAC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Southern California - Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC - Irvine Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
GRU Cancer Center - Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland - Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1903
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univeristy of Texas Health Science Center in San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22203732
Description
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
Learn more about this trial
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
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