PRO 02/ML28897 MY PATHWAY STUDY
PRO 02/ML28897 MY PATHWAY STUDY: An Open-Label Phase IIA Study Evaluating Trastuzumab/ Pertuzumab, Erlotinib, Vermurafenib, and Vismodegib in Patients Who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to
Four different treatment regimens will be evaluated simultaneously in groups of patients who have advanced solid tumors that has progressed following administration of standard of care treatment, or for whom no standard therapy exists, or for whom therapies that will convey clinical benefit are not available, and in whom a trial of targeted therapy is considered the best available treatment option.
- Erlotinib is a targeted drug that blocks the activity of epidermal growth factor receptor (EGFR), a protein found in increased amounts in certain cancers. EGFR, when overactive, leads to abnormal cell growth. By blocking the activity of EGFR, erlotinib works to help stop this abnormal growth.
- Trastuzumab and pertuzumab are drugs that target the HER2 receptor, a protein found in high quantities in HER2-positive cancers. Pertuzumab is believed to work in a way that is complementary to trastuzumab, as the two medicines target different regions on the HER2 receptor.
- Vemurafenib is a targeted drug that inhibits BRAF kinase, a protein found in certain cancers. BRAF kinase causes abnormal cell growth. By blocking the activity of the BRAF kinase, vemurafenib stops this abnormal growth. The presence of abnormal BRAF kinase in cancer cells can be detected by finding a mutation in the BRAF gene within the cancer.
- Vismodegib is a targeted drug that inhibits the hedgehog pathway in cancer cells. When overactive, the hedgehog pathway plays an important role in the cell’s ability to grow and multiply as a cancer cell. By blocking the hedgehog pathway, vismodegib can stop this abnormal growth. The hedgehog pathway is known to be overactive in cancers with mutations in the genes responsible for this pathway.
Are you Eligible? (Inclusion Criteria)
- Age 18 years or older
- No previous treatment with the specific assigned study drug
- Progressive cancer at the time of study entry