A Phase IB Study of Serabelisib in Combination with a Specialized Diet in People with Colorectal, Endometrial, or Ovarian Cancer

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Full Title

A Phase 1b Study of Serabelisib in Combination with an Insulin Suppressing Diet (Study ISD) and with or without nab-paclitaxel in Adult Subjects with Advanced Solid Tumors with PIK3CA Mutations with or without PTEN Loss

Purpose

The purpose of this study is to assess the safety and effectiveness of the drug serabelisib in combination with a special diet to treat people with metastatic colorectal, endometrial, or ovarian cancer that contains a mutation in a gene called PIK3CA. Serabelisib blocks the protein made by this gene, called P13K, which can promote cancer growth and spread. By blocking P13K, serabelisib may stop cancer from growing and dividing.

Adding a special diet that is low in carbohydrates and high in fat may help reduce some of the side effects of serabelisib, such as increased sugar and insulin levels, and improve how the drug works. Serabelisib is a tablet that is taken orally (by mouth).

Who Can Join

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

  • Participants must have metastatic colorectal, endometrial, or ovarian cancer that contains a mutation in a gene called PIK3CA.
  • At least 3 weeks must pass between the completion of prior treatment and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Maria Rubinstein at 646-888-6954.

Protocol

22-346

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05300048