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This is a phase I/Ib, open-label, single-center, single-arm study of alisertib and osimertinib for patients with stage IV EGFR-mutated lung cancer, incorporating both a dose escalation and dose-expansion phase
The dose-escalation phase will consist of a modified 3+3 dose escalation and will be open to patients with metastatic lung cancer with an activating EGFR mutation who have progressed on and are currently receiving osimertinib therapy. The dose-escalation and expansion phases will be open to patients who have received any number of therapies as long as they are currently being treated with and tolerating osimertinib 80 mg orally once per day, and who have demonstrated radiographic progression by RECIST 1.1 criteria on their most recent scan.
To determine the safety and tolerability of the combination osimertinib + alisertib in patients with advanced EGFR-mutant NSCLC and identify a recommended phase II dose.
1. To evaluate the clinical efficacy of adding alisertib to osimertinib compared to "historical" data of platinum doublet chemotherapy in patients who have progressed on osimertinib monotherapy.
2. To explore tumor biomarkers, including TPX2, that predict response to osimertinib + alisertib.
3. To evaluate alisertib and osimertinib pharmacokinetics
4. To evaluate the CNS response rate of alisertib + osimertinib
Patients may continue treatment indefinitely until disease progression, intolerance, or other contraindication to study treatment.
Lung Cancer Metastatic
University of California, San Francisco
University of California, San Francisco
Published on BioPortfolio: 2019-09-16T03:26:48-0400
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Tumors or cancer of the LUNG.
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
An estrogen responsive cell line derived from a patient with metastatic human breast ADENOCARCINOMA (at the Michigan Cancer Foundation.)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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Lung cancer is the uncontrolled cell growth in tissues of the lung. Originating in the lungs, this growth may invade adjacent tissues and infiltrate beyond the lungs. Lung cancer, the most common cause of cancer-related death in men and women, is respons...