Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma

Summary

This phase I/II trial studies the side effects and best dose of sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating patients with sarcoma that is too large to be removed (locally advanced) or has spread to other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Timeline

Start

2015-11-30

Primary completion

2018-12-07

Completion

2022-07-11

Outcome

Missed primary endpoint

Stopped: “Interim monitoring”

registry analysis (superiority test); Phase II - Analysis Group 2 MLN0128 vs Phase II - Analysis Group 2 Pazopanib; p = 0.1419; Hazard Ratio (HR) 1.36; Log Rank NCT02601209 ↗

Drugs

Indications