Full TitleA 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)
The purpose of this study is to find the best dose of peposertib (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.
Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin, work in different ways to stop the growth of tumor cells - either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving peposertib and pegylated liposomal doxorubicin may work better in patients with ovarian cancer than pegylated liposomal doxorubicin alone. Peposertib is taken orally (by mouth) and the chemotherapy is given intravenously (by vein).
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.