Midostaurin (PKC412) for Locally Advanced Rectal Cancer

Completed · Phase 1

Conditions studied: Adenocarcinoma of the Rectum

In brief

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.

Key facts

Study ID

NCT01282502

Run by

Massachusetts General Hospital

People needed

19

Starts

2011-08-01

Expected to finish

2018-12-01

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the rectum
• T3/4 or N+ disease
• Life expectancy > 3 months
• Normal organ and marrow function

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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