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

NCT01514526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-04-25

No results posted yet for this study

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.

Conditions

  • Adrenocortical Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • Jesús García-Donás Jiménez, MD · Spanish Oncology Genito-Urinary Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-07-31
Completion
2016-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514526 on ClinicalTrials.gov