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Title:
My Pathway: MY PATHWAY: AN OPEN-LABEL PHASE IIA STUDY EVALUATING TRASTUZUMAB/PERTUZUMAB, ERLOTINIB, VEMURAFENIB/COBIMETINIB, VISMODEGIB, ALECTINIB, AND ATEZOLIZUMAB IN PATIENTS WHO HAVE ADVANCED SOLID TUMORS WITH MUTATIONS OR GENE EXPRESSION ABNORMALITIES PREDICTIVE OF RESPONSE TO ONE OF THESE AGENTS(Protocol Number: ML28897/PRO 02)
Protocol Number:
J1480
Phase:
Phase II
Physician:
Roisin Connolly
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This is a multicenter, non-randomized, open-label Phase IIa study for patients with histologically documented metastatic cancer (solid tumors, not including hematologic malignancies). Four different treatment regimens will be evaluated simultaneously in groups of patients who have advanced solid tumors that have 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.
Eligibility:
Patients must have molecular alterations (mutations, gene expression abnormalities) predictive of response to one of these agents. Patients will have completed molecular testing at a CLIA-certified laboratory showing that tumor tissue demonstrated at least one of the following abnormalities: HER2 overexpression, amplification, or HER2-activating mutation, EGFR-activating mutation, BRAF-activating mutation, or Hedgehog pathway potentially clinically relevant mutation (activating mutation of SMO or loss-of-function mutation of PTCH-1). Molecular testing results used for patient eligibility must have been obtained from the most recent tumor biopsy, which must have been obtained in the metastatic setting. Patients cannot have previous treatment with the specific assigned study drug or any other drug sharing the same target. Patients will be considered if they are in good physical condition and laboratory results indicate adequate hematologic, renal and liver function.
Treatment:
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. This is given by IV infusion as an outpatient every 3 weeks. Erlotinib is a targeted drug that blocks the activity of epidermal growth factor receptor (EGFR), a protein found in increased amounts in certain cancers. This is an oral medication given and the treatment cycle is 28 days. Vemurafenib is a targeted drug that inhibits BRAF kinase, a protein found in certain cancers. This is an oral medication and the treatment cycle is 28 days. Vismodegib is a targeted drug that inhibits the hedgehog pathway in cancer cells. This is an oral medication and the treatment cycle is 28 days. Patients will receive therapy for two cycles (8 weeks for oral drugs, 6 weeks for trastuzumab/pertuzumab), and will then be evaluated for response. Patients with objective response or stable disease will continue therapy, with repeat evaluations after every two cycles for the first 24 weeks, followed by repeat evaluations every 12 weeks, until tumor progression, occurrence of unacceptable toxicity, or other discontinuation criteria is met.
Population:
Adult
Last Update
03/05/2019 05:03 AM