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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: Non applicable
Sponsor: Spanish Oncology Genito-Urinary Group

Current Primary Outcome: Efficacy [ Time Frame: Up to 6 months (Study treatment expected duration) ]

Efficacy in terms of overall response rate (ORR) of dovitinib as treatment for metastatic or locally advanced non-resectable primary adrenocortical carcinoma (measured by an external evaluator)


Original Primary Outcome: Efficacy in terms of overall response rate (ORR) of dovitinib as treatment for metastatic or locally advanced non-resectable primary adrenocortical carcinoma (measured by an external evaluator) [ Time Frame: Up to 6 months (Study treatment expected duration) ]

Current Secondary Outcome:

  • Safety profile of dovitinib in study population [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    Safety will be assessed considering the number of study participants with Adverse Events during the conduct of the trial, from date of patient inclusion until the date of study end, up to 24 months.
  • Efficacy of dovitinib in reducing ACC hormonal production (cortisol, testosterone, aldosterone or estrogens) [ Time Frame: Up to 6 months (Study treatment expected duration) ]
    Efficacy of dovitinib in reducing ACC hormonal production (cortisol, testosterone, aldosterone or estrogens)
  • Progression free survival (PFS) in all treated patients (measured by an external evaluator) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of first documented progression, assessed up to 24 months.
  • Overall survival (OS)(measured by an external evaluator) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of of death from any cause, assessed up to 24 months.
  • Quality of Life (QoL) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of study end, up to 24 months.
  • Progression Free Survival and Overall Survival (determined by the local researchers) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.


Original Secondary Outcome:

  • Safety profile of dovitinib in study population [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    Safety will be assesed considering the number of study participants with Adverse Events during the conduct of the trial, from date of patient inclusion until the date of study end, up to 24 months.
  • Efficacy of dovitinib in reducing ACC hormonal production (cortisol, testosterone, aldosterone or estrogens) [ Time Frame: Up to 6 months (Study treatment expected duration) ]
  • Progression free survival (PFS) in all treated patients (measured by an external evaluator) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of first documented progression, assessed up to 24 months.
  • Overall survival (OS)(measured by an external evaluator) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of of death from any cause, assessed up to 24 months.
  • Quality of Life (QoL) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of study end, up to 24 months.
  • Progression Free Survival and Overall Survival (determined by the local researchers) [ Time Frame: Up to 24 months (Study expected duration, including patient treatment and follow up) ]
    From date of patient inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.


Information By: Spanish Oncology Genito-Urinary Group

Dates:
Date Received: December 21, 2011
Date Started: January 2012
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2016