A Phase I/II Study of MLN0128 (Sapanisertib) versus Pazopanib in Patients with Locally Advanced, Inoperable, or Metastatic Sarcoma

Full Title

A Phase I/Randomized Phase II Study of MLN0128 vs. Pazopanib in Patients with Locally Advanced/Unresectable and/or Metastatic Sarcoma (Alliance A091304) (CIRB)

Purpose

Pazopanib is a drug approved for the treatment of soft-tissue sarcoma. Doctors continue to seek new drugs for sarcoma that slow the cancer's growth and extend patients' lives. In this study, researchers are comparing the safety and effectiveness of the investigational drug MLN0128 (sapanisertib) with pazopanib in patients with locally advanced, inoperable, or metastatic sarcoma.

Sapanisertib interferes with cancer growth by blocking a protein called mTOR, while pazopanib blocks an enzyme involved in cancer growth called tyrosine kinase. Patients will be randomly assigned to receive sapanisertib or pazopanib. Both drugs are taken orally (by mouth).

Eligibility

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

  • Patients must have locally advanced, inoperable, or metastatic sarcoma that continues to grow despite prior therapy.
  • At least 4 weeks must pass between completion of previous treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tap at 646-888-4163.

Protocol

16-036

Phase

I/II

Investigator

Co-Investigators

Locations