A Phase I Study of BVD-523 in Patients with Advanced Cancers

Protocol
13-254
Full Title
A Phase 1 Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients with Advanced Malignancies
Phase
I
Purpose

The purpose of Part 1of this study is to find the highest dose of an investigational drug called BVD-523 that can be given safely to patients with advanced cancers that have continued to grow despite standard therapy, or for which no standard therapy exists. In Part 2 of the study, researchers will also observe the preliminary effectiveness of BVD-523 against certain cancers, including melanoma.

BVD-523 works by blocking the functions of a protein called extracellular signal-related kinase (ERK), which is part of a major pathway involved in the growth and spread of several types of cancer. BVD-523 is a pill that is taken orally (by mouth).

Eligibility

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

  • Patients must have an advanced cancer that has continued to grow despite standard therapy or for which no standard therapy exists.
  • Patients may have received up to two prior regimens of therapy for metastatic cancer.
  • In Part 2 of this study, patients must have certain types of cancer with certain genetic mutations.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Solit at 646-422-4459.

Disease(s)
Melanoma
Solid Tumors
Locations
Related Diseases