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
Phase II
NCT02091141
Cancer, All Other
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
  • Oncology and Hematology Care Willamette Falls