Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

Summary

* Design: non-randomized, open label, phase II clinical trial. * Study population and disease: adult patients with metastatic or locally advanced non-resectable adrenocortical carcinoma, confirmed histologically. * Estimated number of patients: 15. * Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2 days off. * Treatment duration: study treatment period will be continued until disease progression, unacceptable toxicity, death or premature withdrawal from study. An average of 6 months treatment period is expected. * Study duration: expected recruitment period will be 18 months, and patients will be followed for 6 additional months after last patient is included in the trial.Study total expected duration is 24 months. * Sites: the study is planned to be conducted in 7 Spanish centers.

Timeline

Start

2012-01

Primary completion

2013-07

Completion

2016-11

Drugs

Indications