A Phase IB/II Study of Talazoparib and Axitinib for People with Previously Treated Advanced Kidney Cancer

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Full Title

A Phase Ib/II Study of Talazoparib and Axitinib in Metastatic Renal Cell Carcinoma

Purpose

This study has two principal aims. The first is to determine the optimal medication dose to use when combining two oral drugs, talazoparib and axitinib, in patients with metastatic kidney cancer that came back or continued to grow despite prior treatment. The second is to see how effective that dose level is in these patients.

Axitinib blocks the development of blood vessels that cancer cells need to grow and spread (“angiogenesis”). Talazoparib prevents cancer cells from repairing their DNA, which eventually leads to their death. Studies suggest that combining axitinib and talazoparib may be more effective than giving either drug on its own.

Axitinib is already used for previously treated kidney cancer, and talazoparib is used to treat certain breast cancers. Their use together in this study is considered investigational. Both drugs are 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 inoperable or metastatic clear cell renal cell cancer that persists or came back despite prior treatment that included immunotherapy and an angiogenesis inhibitor.
  • Prior treatment with axitinib and talazoparib is not permitted.
  • The number of prior cancer treatments received is taken into account in determining whether patients are eligible.
  • At least 3 weeks must pass since the completion of prior therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • Patients must have adequate organ function, based on blood tests before study entry.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-888-4544.

Protocol

20-001

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators