Selumetinib in Cancers With BRAF Mutations

Completed · Phase 2

Conditions studied: Adult Solid Neoplasm

In brief

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 blocking a protein called MEK, which is known to play a role in the growth of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of cancers that have mutations in the BRAF gene and depend on the activity of this gene for their growth and survival.

Key facts

Study ID

NCT00888134

Run by

National Cancer Institute (NCI)

People needed

28

Starts

2009-07-01

Expected to finish

2015-01-01

Last updated by the study team

2016-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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