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Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer

Phase 1
18 Years
Open (Enrolling)
Adenocarcinoma of the Rectum

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Trial Information

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Theodore S Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Rectum
  • rectal cancer
  • chemotherapy
  • chemoradiation
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115