A Phase IA Study of PF-06873600 in Patients with Advanced Breast Cancer

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Full Title

Phase 1/2a Dose Escalation and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Anti-tumor Activity of PF-06873600 as a Single Agent and in Combination with Endocrine Therapy

Purpose

The purpose of this study is to find the highest dose of the investigational drug PF-06873600 that can be given safely in patients with advanced or metastatic HER2-negative breast cancer that has continued to grow despite prior treatment. Eventually, researchers would like to evaluate PF-06873600 in combination with hormonal therapy. The goal of this part of the study is to find the best dose.

PF-06873600 is thought to work by blocking growth signals in cancer cells. In a normal cell, “regulator proteins” make sure that the cell is healthy, and they signal that the cell is ready to divide (which is how cells grow and increase in number). But this regulatory process does not work well in cancer cells, which divide and grow uncontrollably. Laboratory studies have shown that PF-06873600 may prevent breast cancer cells from growing. PF-06873600 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 advanced or metastatic breast cancer that has continued to grow despite prior treatment with a CDK4/6 inhibitor and hormonal therapy and one or two prior regimens of chemotherapy.
  • Patients’ cancers must be negative for the HER2 protein.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Mahelia Bissassar at 646-888-5072 or Micaela Rodine at 646-888-4956. The Principal Investigator of this study is Dr. Komal Jhaveri.

Protocol

18-502

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases