This study was conducted in subjects with grade IV astrocytic tumors (a type of cancer that can occur in the brain or spinal cord) in first or second relapse.
The goal of this clinical trial is to learn if the drug cabozantinib works for people with astrocytic tumors. It also was designed to learn about the safety of cabozantinib. The main questions are: 1. Does cabozantinib work and how well do patients tolerate the drug for over 12 weeks. 2. Was the drug safe and how well could patients tolerate treatment for the entire treatment period. Participants were assigned to one of the four treatment groups: Arm 1. Take cabozantinib at a dose of 25 mg once every day (po QD) continuously until progression. Arm 2. Take cabozantinib at a dose of 75 mg once every day continuously until progression. Arm 3. Take cabozantinib at a dose of 125 mg once every day for 2 weeks, followed by 50 mg every day (po QD) for the remainder of the treatment period; Arm 4. Take cabozantinib at a dose of 125 mg once every day for 2 weeks, followed by 1 week off. For the remainder of the treatment period, patients received cabozantinib at a dose of 125 mg once every day for three weeks followed by one week of rest.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Encinitas, California, United States
Unnamed facility
Pleasant Hill, California, United States
Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any event with an onset date on or after the date of first dose of study drug, or any ongoing event on the date of first dose that worsened in severity after the date of first dose. TEAEs were defined as AEs that started on or after the first administration of study drug up to the date of last dose plus 30 days. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Time frame: Up to 13 months
Expansion Phase: Objective Response Rate (ORR)
ORR was defined as the number of participants for whom the best overall response at the time of data cutoff is confirmed complete response (CR) or confirmed partial response (PR) as assessed per modified Response Assessment in Neuro-Oncology (RANO) criteria. CR = Disappearance of all enhancing target lesion(s) and no glucocorticoids (other than a physiologic replacement dose of a maximum of 1.2 mg dexamethasone equivalent dose per day) taken for the 5 days immediately preceding the date of the current magnetic resonance imaging (MRI). PR = ≥50% decrease in the sum of the products of perpendicular diameters of all target enhancing lesions on the current MRI scan compared to the baseline MRI scan and glucocorticoids stable or decreased. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses.
Time frame: Up to 13 months
Expansion Phase: Progression Free Survival at 6 Months as Per Independent Radiology Facility
Progression-free survival at 6 months (PFS6) was defined as the proportion of participants alive and progression-free 182 days after Study Day 1. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses.
Time frame: Month 6
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Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Amherst, New York, United States
Unnamed facility
Rochester, New York, United States
...and 9 more locations