A Phase I Study of PF-07284890 to Treat Solid Tumors with a BRAF Mutation

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Full Title

A Two-Part, Phase 1A/B, Open-Label, Multicenter Trial Evaluating Pharmacokinetics, Safety and Efficacy of PF-07284890 (ARRY-461) in Participants with BRAF V600-MUTANT Solid Tumors with and without Brain Involvement

Purpose

The purpose of this study is to assess the investigational drug PF-07284890, given alone or in combination with binimetinib, in patients with advanced solid tumors that have grown despite treatment and contain a BRAFV600 gene mutation. The BRAFV600 gene makes a protein involved in cell growth. PF-07284890 blocks the activity of this protein; researchers believe that PF-07284890, given alone or in combination with binimetinib, may stop cancer cells from growing and spreading. Both medications are taken orally (by mouth).

In the first part of the study, researchers will determine the highest dose of PF-07284890 that can be given safely alone and with binimetinib; the dose of binimetinib will remain the same as escalating doses of PF-07284890 are assessed. In the second part of the study, the recommended dose of PF-07284890 that was determined in the first part of the study will be given to new groups of patients who receive either PF-07284890 alone or PF-07284890 plus binimetinib.

PF-07284890 is also thought to enter the brain more effectively than currently available medications that block BRAFV600 mutations. This study may therefore be best suited for patients with tumors that grow within the brain or have spread to the brain.

Eligibility

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

  • Patients must have melanoma, non-small cell lung cancer, a brain tumor, or other solid tumor that contains a BRAFV600 mutation and has continued to grow or spread despite treatment.
  • Patients with cancers that have spread to the brain may be eligible.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to ask about eligibility, please call 646-888-4226.

Protocol

21-255

Phase

I

Investigator

Co-Investigators