A Phase I Study of XRD-0394 in People with Cancer Who Are Receiving Palliative Radiation Therapy

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Full Title

A Phase 1, Open-Label, Dose-Finding, Pharmacokinetic, and Pharmacodynamic Study of XRD-0394 in Subjects with Metastatic, Locally Advanced, or Recurrent Cancer Receiving Palliative Radiotherapy

Purpose

Palliative radiation therapy is the use of radiation to relieve the discomfort of cancer. Researchers believe that adding the investigational drug XRD-0394 to palliative radiation may be an effective treatment for cancer. In this study, they are seeking the best dose of XRD-0394 that can be given with palliative radiation in people with recurrent, locally advanced, or metastatic cancer.

XRD-0394 blocks proteins that allow cells to respond to DNA damage from radiation. By blocking these proteins, it may make cancer tumors more sensitive and responsive to radiation therapy. XRD-0394 is taken orally (by mouth).

This study will treat a small number of patients in a staggered format.

Eligibility

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

  • Patients must have recurrent, locally advanced, or metastatic cancer and be planning to receive palliative radiation therapy.
  • At least two weeks must pass between the completion of prior anticancer treatments and receipt of XRD-0394.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan T. Yang at 212-639-8157.

Protocol

21-241

Phase

I

Investigator

Yang, Jonathan, MD, PhD

Co-Investigators