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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANG1005 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG1005 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial objective response rate (iORR) | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty Lawrence | Angiochem Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | United States | ||
| UC San Diego Moores Cancer Center |
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| Label | URL |
|---|---|
| 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 | View source |
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| 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 |
| Number of Patients with adverse events | Upon enrollment through end of study period (1 year after last patient is enrolled |
| Plasma pharmacokinetics of ANG1005 | To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2) | On Day 1 of Cycles 1 and 3 |
| Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Intracranial clinical benefit rate (iCBR) at 3 and 6 months | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Potential immunogenicity of ANG1005 | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C531859 | paclitaxel-Angiopep-2 conjugate |
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