Status:
COMPLETED
Selumetinib in Cancers With BRAF Mutations
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine if selumetinib is safe and effective in treating patients with cancers with a mutated BRAF gene. Selumetinib is an investigational drug that works by...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the objective response rate to AZD6244 (selumetinib) in patients with cancers other than melanoma in which BRAF mutations have been identified prospectively. SECON...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign a written informed consent document
- Histologically confirmed metastatic or unresectable solid tumor
- Results from tumor tissue analysis that show a glutamic acid-for-valine substitution at amino acid position 600 in the BRAF gene (V600E) or other activating BRAF mutation, as determined by high-throughput genotyping
- Patients may have received any number of prior systemic treatments for their cancer
- At least one measurable site of disease by CT, according to standard RECIST criteria 1.0
- ECOG performance status 0-1
- Absolute neutrophil count \> 1500 per cubic mm
- Platelet count \> 100,000 per cubic mm
- Hemoglobin \> 9 g/dl
- Serum bilirubin \< 1.5 x upper limit of normal
- Serum AST and ALT \< 2.5 x upper limit of normal (=\< 5 x upper limit of normal, for liver metastases)
- Serum creatinine \< 1.5 x upper limit of normal
- For women of childbearing potential, negative serum pregnancy test and use of physician-approved method of birth control throughout the study
Exclusion
- Estimated life expectancy \> 12 weeks
- Patients with melanoma
- Have received chemotherapy or radiotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C), or a targeted therapy within 2 weeks prior to entering the study
- Have not recovered from adverse events due to agents previously administered (CTCAE v3 grade 1 or baseline)
- Currently receiving other investigational agents
- Known brain metastases, unless treated and stable off of corticosteroids for at least four weeks
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244
- Prior treatment with a selective inhibitor of RAF or MEK (e.g., RAF265); (note: prior sorafenib is allowed)
- Uncontrolled intercurrent illness, including but not limited to:
- Clinically significant active infection
- Symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia other than atrial fibrillation
- Psychiatric illness/social situations that would limit compliance with study requirements
- Refractory nausea or vomiting, swallowing disorder, or malabsorption syndrome that would interfere with swallowing or absorbing the study medication
- Pregnant and/or breast-feeding women
- Previous or concurrent malignancy, except for the following circumstances:
- Disease-free for at least three years and deemed by investigator to be at low risk for recurrence of that malignancy
- Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin)
- History of solid organ transplantation or other condition requiring the use of immunosuppressive medications
- Uncontrolled hypertension (systolic BP \>= 150 or diastolic BP \>= 100 that cannot be controlled with medications)
- A mean left ventricular ejection fraction (LVEF) less than 45%
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00888134
Start Date
July 1 2009
End Date
January 1 2015
Last Update
January 15 2016
Active Locations (5)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129