Midostaurin (PKC412) for Locally Advanced Rectal Cancer
Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
1 other identifier
interventional
19
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2011
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 12, 2018
December 1, 2018
3.6 years
January 21, 2011
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
1.5 years
Secondary Outcomes (4)
To determine the rate of Dworak Tumor Regression Grade 3/4 for locally advanced rectal cancer treated with study combination at the MTD, stratified by KRAS status (mutant vs. wild type)
1.5 years
To determine surgical complication rate in patients who received preoperative radiation therapy
1.5 years
Perform an exploratory analysis of the impact of selected mutations in APC, PTEN, BRAF, NRAS, and PIK3CA, among other genes
1.5 year
To evaluate proteomic markers of response and resistance to midostaurin-based chemoradiation
1.5 years
Study Arms (1)
Midostaurin with chemoradiation
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore S Hong, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 25, 2011
Study Start
August 1, 2011
Primary Completion
March 1, 2015
Study Completion
December 1, 2018
Last Updated
December 12, 2018
Record last verified: 2018-12