Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Squamous NSCLC Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01861197
• Other study ID #: 2012-09-070-002
• Status: Recruiting
• Phase: Phase 2
• First received: May 21, 2013
• Last updated: May 22, 2013
• Start date: March 2013

Study information

• Verified date: May 2013
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn
• Phone: 822-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Efficacy of Dovitinib for Squamous NSCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed squamous NSCLC

• Previously treated with one or two lines of chemotherapy

• FGFR amplification (FISH > 5 copies of genes)

• 20 years or older

• ECOG PS 0-2

Exclusion Criteria:

• active infection

• uncontrolled brain metastasis

• unstable angina or MI

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Squamous NSCLC

Intervention

Drug:
• Dovitinib
Dovitinib 500mg daily for 5 days on/ 2 day off until progression

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		6 months	No