Clinical trial · Interventional
Midostaurin (PKC412) for Locally Advanced Rectal Cancer
Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Midostaurin | Drug | Midostaurin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Midostaurin with chemoradiation
- interventionNames
- Drug: Midostaurin
Primary outcomes (1)
- measure
- To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
- timeFrame
- 1.5 years
Secondary outcomes (4)
- measure
- 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)
- timeFrame
- 1.5 years
- measure
- To determine surgical complication rate in patients who received preoperative radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available