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Midostaurin (PKC412) for Locally Advanced Rectal Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Radiation Oncology, Gastrointestinal Malignancies
NCT ID: NCT01282502 (View complete trial on
DFCI Protocol ID: 10-457


This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call 5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of kinase inhibitor which works by blocking proteins associated with cancer cell growth. Previous studies also suggest that midostaurin may help increase the effectiveness of radiation therapy. In this research we are looking for the highest dose of midostaurin that can be given safely in combination with standard chemoradiation.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Theodore Hong, MD, Massachusetts General Hospital

Site-responsible Investigators:
Harvey Mamon, MD, PhD, Brigham and Women's Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Beverly Spicer, 617-632-5264,

Eligibility Criteria

Inclusion Criteria: - Adenocarcinoma of the rectum - T3/4 or N+ disease - Life expectancy > 3 months - Normal organ and marrow function Exclusion Criteria: - Metastatic disease - Pregnant or breastfeeding - Prior radiotherapy - Receiving other investigational agents - History of inflammatory bowel disease - Active scleroderma or CREST syndrome - Uncontrolled intercurrent illness - History of a different malignancy unless disease free for at least 5 years - HIV or active viral hepatitis - Impaired cardiac function
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