- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282502
Midostaurin (PKC412) for Locally Advanced Rectal Cancer
Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Midostaurin with chemoradiation
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50 mg BID for 8 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
Time Frame: 1.5 years
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: 1.5 years
|
1.5 years
|
To determine surgical complication rate in patients who received preoperative radiation therapy
Time Frame: 1.5 years
|
1.5 years
|
Perform an exploratory analysis of the impact of selected mutations in APC, PTEN, BRAF, NRAS, and PIK3CA, among other genes
Time Frame: 1.5 year
|
1.5 year
|
To evaluate proteomic markers of response and resistance to midostaurin-based chemoradiation
Time Frame: 1.5 years
|
1.5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Midostaurin
Other Study ID Numbers
- 10-457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma of the Rectum
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Centre Leon BerardMerck Sharp & Dohme LLC; Debiopharm International SACompletedAdenocarcinoma of the Pancreas | Adenocarcinoma of the Rectum | Adenocarcinoma of the ColonFrance
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Weill Medical College of Cornell UniversitySanofiWithdrawnAdenocarcinoma of the Rectum | Adenocarcinoma of the ColonUnited States
-
Washington University School of MedicineCompletedRectal Cancer | Cancer of Rectum | Cancer of the Rectum | Neoplasm, Rectum | Rectum Cancer | Rectum Neoplasms | Adenocarcinoma of the RectumUnited States
-
TheraOpActive, not recruitingAdenocarcinoma of the Rectum | Adenocarcinoma of the ColonGermany
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage I Colon Cancer | Stage I Rectal Cancer
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John HaysSanofiUnknownMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal CancerUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingAdenocarcinoma of the Rectum | Adenocarcinoma of the ColonUnited States
-
National Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Adenocarcinoma of the Rectum | Adenocarcinoma...United States
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University of California, DavisNational Cancer Institute (NCI); Millennium Pharmaceuticals, Inc.CompletedUnspecified Adult Solid Tumor, Protocol Specific | Mucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IIIA Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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UNC Lineberger Comprehensive Cancer CenterWithdrawnCrossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRIAdvanced Adenocarcinoma of the Colon or RectumUnited States
Clinical Trials on Midostaurin
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University Medical Center GroningenUnknown
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Novartis PharmaceuticalsAvailableAcute Myeloid Leukemia | Mast Cell Leukemia | Aggressive Systemic Mastocytosis | Systemic Mastocytosis With an Associated Hematologic Neoplasm | FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia
-
Novartis PharmaceuticalsCompletedAML and High Risk MDSGermany, Italy, France, Netherlands, United States, Australia, Japan
-
Novartis PharmaceuticalsCompletedLeukemiaUnited States, Belgium, Netherlands, Canada, Austria, Germany, Australia, United Kingdom, Turkey, France, Poland, Norway
-
Novartis PharmaceuticalsTerminatedAcute Myeloid Leukemia | Acute Lymphoblastic LeukemiaSweden, Italy, France, United States, Netherlands
-
Technische Universität DresdenNovartis PharmaceuticalsCompletedAcute Myeloid LeukemiaGermany
-
University of KansasNovartisCompletedAcute Myeloid LeukemiaUnited States
-
Novartis PharmaceuticalsRecruitingFollicular Lymphoma | Acute Lymphoblastic Leukemia | Diffuse Large B-cell LymphomaBrazil
-
Technische Universität DresdenPfizer; Novartis PharmaceuticalsRecruiting
-
Richard Stone, MDMassachusetts General Hospital; Novartis; Beth Israel Deaconess Medical Center; Brigham and Women's HospitalActive, not recruitingRAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDSAcute Myeloid Leukemia | Myelodysplastic SyndromeUnited States