Phase I Study of Nilotinib Given With Radiation For Patients With High Risk Chordoma
Nilotinib will be taken orally daily in two cycles of 28 days each. Two weeks after taking
nilotinib, subjects will begin radiation therapy. Radiation therapy will continue every
weekday until Day 56 of the study. If it is determined that the subject's tumor cannot be
removed by surgery, an additional 3 weeks of radiation therapy will be applied after Day 56
of the study.
During study visits subjects will have physical exams, routine blood tests, urine and blood
clotting tests, and EKGs. Subjects will also have tumor assessment by chest CT and MRI or CT
of the tumor at screening, on approximately Day 56 of the study, then every 6 months for one
year and then annually thereafter if ther is no disease progression.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).
A DLT will be defined as any of the following events occurring during days 1-56 of study according to CTCAE version 4.0. MTD is then determined by identifying a dose cohort demonstrating > or = 30% rate of DLTs, which are defined as: Any Grade ≥ 3 nonhematologic toxicity except alopecia, nausea, or vomiting not otherwise controlled by maximual supportive care. Grade 4 neutropenia (ANC < 500/µL) lasting > 5 days, Grade 3 thrombocytopenia lasting > 7 days, or Grade 4 thrombocytopenia Failure to resume treatment delays within a defined period of time.
Edwin Choy, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|