Who is sponsoring NCT00747799?

NCT00747799 is sponsored by Sun Yat-sen University.

What condition does NCT00747799 study?

NCT00747799 studies Nasopharyngeal Neoplasms.

What drugs are being tested in NCT00747799?

Interventions: Sorafenib plus Cisplatin and 5-fluorouracil.

What is the status of NCT00747799?

NCT00747799 is currently COMPLETED.

Last reviewed 2013-12-08 · How we verify

Phase II Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Are Failure of Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

NCT00747799 Phase 2 COMPLETED

This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	COMPLETED
Enrolment	54
Start date	2009-01
Completion	2011-11

Conditions

Nasopharyngeal Neoplasms

Interventions

Sorafenib plus Cisplatin and 5-fluorouracil

Primary outcomes

Objective response rate (CR+PR) — January 2009 to May 2011
In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.

Countries

China