A Phase I/II Study of Cobimetinib in Children and Young Adults with Previously Treated Solid Tumors

Full Title

A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Patients with Previously Treated Solid Tumors

Purpose

Cobimetinib is an anticancer drug approved for treating advanced melanoma. It works by inhibiting MEK, a protein which fuels cancer growth. In this study, researchers want to find the highest dose of cobimetinib that can be given safely (dose-escalation) in children with solid tumors that have continued to grow despite standard therapy and in young adults with persistent pediatric solid tumors. They also want to observe the effectiveness of this treatment (dose-expansion).

Cobimetinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • The dose-escalation phase of the study is for patients ages 6 to less than 18. The dose-expansion phase of the study is for patients ages 6 to less than 30.
  • Patients must have a solid tumor fueled by MEK that has continued to grow despite standard therapy or for which no standard therapy exists. Examples of tumors in which MEK may be active include brain tumors, soft-tissue sarcoma, neuroblastoma, melanoma, peripheral nerve sheath tumors, rhabdoid tumors, neurofibroma, and Schwannoma.
  • Patients must recover from the serious side effects of prior therapies before entering the study.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Protocol

16-041

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Locations