RWF_ML28897

My Pathway: An Open Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

This is a multicenter, non-randomized, open-label study designed to evaluate four treatment regimens in patients with advanced cancer for whom there is no available, beneficial treatment. Patients with HER2 overexpression, amplification, or -activating mutation will be treated with Herceptin/Perjeta; those with epidermal growth factor receptor (EGFR), with Tarceva; those with BRAF-activating mutation, with Zelboraf; and those with Hedehog pathway potentially clinically relevant mutation, with Erivedge. Treatment will continue until disease progression or unacceptable toxicity occurs. Study is expected to last up to 5 years.

Inclusion Criteria:
• Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
• Molecular testing results from certified laboratories (using tissue from the most recent tumor biopsy in the metastatic setting) that show at least one of the following abnormalities: HER2 overexpression, amplification, or HER2-activating mutation
EGFR-activating mutation, BRAF-activating mutation, Hedgehog pathway potentially clinically relevant mutation (activating mutation of SMO or loss-of-function mutation of PTCH-1)
• Patients who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible patients should not have available therapies that will convey clinical benefit.
• No previous treatment with the specific assigned study drug or any other drug sharing the same target
• Progressive cancer at the time of study entry

Exclusion Criteria:
• Participants with hematologic malignancies
• Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade: Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy • Active or untreated brain metastases
• History of carcinomatous meningitis
• Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
• Pregnant or breastfeeding women, or intending to become pregnant during the study
• Any significant cardiovascular events within 6 months prior to study entry
• Pulmonary embolism within 30 days prior to study entry
• History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
• Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
• Eligible for another actively accruing Roche/Genentech-sponsored interventional clinical trial
Phase II
NCT02091141
Cancer
Multiple Tumor Types
Rachel Sanborn, M.D.
Genentech
Melissa Pomeroy
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside