Adrenocortical Carcinoma Clinical Trial
Official title:
Phase II Clinical Trial of Dovitinib (TKI-258) in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma
- 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.
Non applicable ;
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