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This Phase 1 study examines the drug Midostaurin (PKC412) in patients with locally advanced rectal cancer. It included patients with T3/4 or node-positive adenocarcinoma of the rectum and normal organ and bone marrow function. It was carried out in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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