Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
Midostaurin capsules will be taken by mouth for 8 weeks. For the first 2 weeks midostaurin
will be taken alone (no chemoradiation). After 2 weeks standard chemoradiation will be
added to the midostaurin regimen. Subjects receive midostaurin and chemoradiation for an
additional 6 weeks. Physical exams will be done weekly. Blood samples will be taken and an
optional tumor biopsy will be performed in week 2.
4-5 weeks after completing chemoradiation and midostaurin subjects will undergo surgery as
standard of care. Tumor tissue from the surgery will be used for research purposes. A Ct
scan of chest, abdomen, and pelvis will be performed.
After completion of surgery, subjects will have an end of study visit with physical exam,
blood tests. CT scans of chest, abdomen, and pelvis will be performed yearly for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
Theodore S Hong, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|