This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
See above.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
Moores UC San Diego Cancer Center
La Jolla, California, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Objective Response Rate (ORR) (Arms 1 and 3)
To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma World Health Organization (WHO) Grade III patients (Arm 3)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
PFS3 (Arm 2)
To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
ORR in Arm 2
To determine the ORR in Arm 2
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
PFS at 3, 6 and 12 months
* To determine the number of patients without progression at 3, 6 and 12 months in Arms 1 and 3 * To determine the number of patients without progression at 6 and 12 months in Arm 2
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median PFS
To determine the median progression-free survival in each arm
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of response
To determine the median duration of response in each arm
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Overall survival
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
...and 2 more locations
To determine the median overall survival in each arm
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Safety and tolerability
To determine the number of participants with adverse events
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC])
To determine the drug concentration and distribution in the blood (plasma)
Time frame: At 0 h (pre-dose), at the end of infusion, at 2 and 4 hours post-dose on Day 1 of treatment cycles 1 and 3 (Week 1 and Week 9)