A Phase II Study of Olaparib plus Ceralasertib in People with Recurrent Osteosarcoma

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Full Title

Phase II Trial of Olaparib in Combination with Ceralasertib in Patients with Recurrent Osteosarcoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the anticancer drug olaparib and the investigational drug ceralasertib in adolescents and young adults with osteosarcoma (bone cancer) that has come back or continues to grow after prior treatment.

Olaparib is a type of medication called a PARP inhibitor. These drugs block PARP proteins from repairing damage in cancer cells, and this blocking action may cause the cancer cells to die. Ceralasertib blocks a protein called ATR that helps repair DNA damage to cancer cells. When given in combination, these drugs have more activity together against cancer than they do when given separately. Both medications are tablets that taken orally (by mouth).

There are two groups in this study:

  • Group 1 will include patients with inoperable osteosarcoma that has come back or stopped responding to therapy
  • Group 2 will include patients with osteosarcoma that has come back in their lungs and can be surgically removed. In addition to receiving olaparib and ceralasertib, they will have surgery to remove the cancer from their lungs.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have persistent or recurrent inoperable osteosarcoma OR recurrent operable osteosarcoma that has spread to the lungs.
  • At least 3 weeks must pass since the completion of previous therapies and receipt of the study treatment.
  • 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 12-40 who weigh at least 40 kilograms (88.1 pounds).

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-373

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Kinnaman, Michael, MD