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Clinical Trial 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.


Clinical Trial Description

Non applicable ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01514526
Study type Interventional
Source Spanish Oncology Genito-Urinary Group
Contact
Status Completed
Phase Phase 2
Start date January 2012
Completion date November 2016

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