A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Dana Farber Cancer Institute SC (1)
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Incident rate of dose limiting toxicities (DLTs)
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Time frame: 21 days
Incidence of adverse events (AEs)
To characterize the safety and tolerability of IDH305
Time frame: 30 months
Plasma PK parameters (AUC, Cmax, Tmax)
To characterize the PK profile of IDH305
Time frame: 30 months
Changes of 2-hydroxyglutarate concentration in patient specimens
To characterize the PD profile of IDH305
Time frame: 30 months
Overall response rate (ORR)
To assess any preliminary anti-tumor activity of IDH305
Time frame: 30 months
Incidence of serious adverse events (SAE)
To characterize the safety and tolerability of IDH305
Time frame: 30 months
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Columbia University Medical Center- New York Presbyterian Onc Dept.
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
...and 6 more locations