A Phase 2 Study of Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel in People With Endometrial Cancer

Full Title

An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) with Paclitaxel, and a Substudy Evaluating PIKTOR with Paclitaxel plus an Insulin-Suppressing Diet, in Patients with Advanced or Recurrent Endometrial Cancer

Purpose

Researchers want to see how well the drugs sapanisertib and serabelisib (PIKTOR) work when given together to treat endometrial cancer. The people in this study have endometrial cancer that has come back or grown after treatment. They also have genetic changes in the pathway that PIKTOR targets. These changes can cause resistance to chemotherapy drugs.

If you take part in this study, you will take PIKTOR and also receive paclitaxel. PIKTOR is taken orally (by mouth) and paclitaxel is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

• Have advanced endometrial cancer that grew or came back after treatment and has genetic changes in the PI3K/AKT/mTOR tumor pathway.
• Have had at least 1 but no more than 4 prior regimens of anti-cancer medication.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Maria Rubinstein’s office at 646-888-6954.