NCT02220855

A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas

A Phase II Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Patrick Joseph Loehrer Sr. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thymic tumors are rare tumors, but represent the most common tumors of the anterior mediastinum. Thymoma has an indolent course in advanced disease and has the propensity to spread to the pleura. In first line therapy, combination chemotherapy produces responses in approximately 80% of patients. A number of single agents have activity in recurrent disease, but none are curable. Patients with recurrent thymoma have limited treatment options, and thus novel target modalities are needed. At the Indiana University Simon Cancer Center (IUSCC), more patients with advance thymoma are seen than any other institution in the country. Our main hypothesis is the PI3K pathway is an important driver for growth and metastasis of thymoma and that inhibition of the PI3K pathway is expected to produce clinically meaningful response in patients with recurrent thymoma.

Conditions

• Thymoma

Interventions

Type	Name	Description
DRUG	BKM120

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-03-27
• Completion: 2021-03-09
• First posted: 2014-08-20
• Last updated: 2022-04-11
• Results posted: 2018-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study