Title: Phase II Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas With Dysregulation of the mTOR Pathway1

Description: For this single arm, phase 2 study, researchers are evaluating whether TAK-228, a novel, orally administered mTOR inhibitor, is an efficacious therapy among patients with unresectable or metastatic soft tissue sarcoma.

Patients must be at least 18 years old, have disease displaying PI3K pathway dysregulation, and be refractory to at least 1 prior therapy, excluding neoadjuvant/adjuvant therapy “in a curative setting.”

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Patients will receive 3 mg of the experimental medicine daily for 21 days per cycle.

The primary outcome is progression-free survival among patients with PI3K/AKT/mTOR pathway dysregulation; secondary outcomes include toxicity rates, overall response rate, and overall survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02987959.

Status: This study is open and recruiting participants as of April 17, 2017.

This study is sponsored by Fox Chase Cancer Center.


  1. Clinicaltrials.gov. Study of TAK-228 (MLN0128) in soft tissue sarcomas. NCT02987959. https://clinicaltrials.gov/ct2/show/NCT02987959. Accessed April 17, 2017.