Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To assess the anti-tumor activity associated with trametinib monotherapy in patients with triple negative breast cancer (TNBC). SECONDARY OBJECTIVES: I. To assess the anti-tumor activity associated with trametinib in combination with AKT inhibitor GSK2141795 after progression on trametinib in patients with metastatic TNBC. II. To determine the progression-free survival following the initiation of treatment with trametinib monotherapy in patients with metastatic TNBC. III. To determine the progression-free survival following the initiation of treatment with trametinib in combination with GSK2141795 in patients with metastatic TNBC. IV. To determine the overall survival following the initiation of treatment with trametinib with GSK214179 in patients with metastatic TNBC. V. To determine the nature and degree of toxicities associated with trametinib monotherapy and trametinib in combination with GSK2141795 in patients with metastatic TNBC. VI. To determine the biomarker potential of phosphatase and tensin homolog (PTEN) to predict response to single agent trametinib. VII. To determine molecular markers of sensitivity and resistance to trametinib monotherapy and trametinib in combination with GSK2141795 in patients with metastatic TNBC. OUTLINE: PART 1: Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 52 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
