NCT01514526

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

Phase II Clinical Trial of Dovitinib (TKI-258) in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non applicable

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	Dovitinib	Dovitinib (TKI-258), gelatin capsule of 100mg, developed and supplied by Novartis Inc. The study regimen consists of the administration of 500 mg / day (5 x 100mg) once daily, taken orally with a large amount of water, preferably one hour prior to a meal or at least two hours following a meal. This dose will be taken once daily according to 5 days on/2 days off schedule. The patient will continue on treatment until disease progression,unacceptable toxicity, death or premature withdrawal.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-07-01
• Completion: 2016-11-01
• First posted: 2012-01-23
• Last updated: 2017-04-25

Locations

7 sites across 1 country: Spain