A Phase I Study Combining M3814 with Standard Chemotherapy in Patients with Platinum-Resistant Ovarian Cancer

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Full Title

A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum-Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)(NCI 10324) (CIRB)

Purpose

The purpose of this study is to find the best dose of M3814 that can be given in combination with standard chemotherapy (a drug called pegylated liposomal doxorubicin) in women with ovarian cancer that has continued to grow or came back despite prior chemotherapy that included a platinum-containing drug. Once the best dose is found, the treatment will be assessed in women with low-grade and high-grade serous ovarian cancer.

Anticancer treatments damage the genetic material (DNA) of cancer cells, but the cells often learn to repair the damage. M3814 blocks the activity of the enzymes that cancer cells use to repair their DNA, making them more vulnerable to the lethal effects of chemotherapy such as pegylated liposomal doxorubicin. M3814 is taken orally (by mouth) and the chemotherapy is given intravenously (by vein).

Eligibility

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

  • Patients must have ovarian cancer that has come back or continued to grow despite prior treatment.
  • Patients may not have previously received doxorubicin or pegylated liposomal doxorubicin.
  • At least 4 weeks must pass between 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rachel Grisham at 646-888-4653.

Protocol

20-193

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators