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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01861197
Recruitment Status : Unknown
Verified May 2013 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Brief Summary:
Efficacy of Dovitinib for Squamous NSCLC.

Condition or disease Intervention/treatment Phase
Squamous NSCLC Drug: Dovitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2013
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dovitinib monotherapy Drug: Dovitinib
Dovitinib 500mg daily for 5 days on/ 2 day off until progression

Primary Outcome Measures :
  1. response rate [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01861197

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Contact: Myung-Ju Ahn 822-3410-3459

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Ph.D.    822-3410-3459   
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Myung-Ju Ahn Samsung Medical Center
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Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center Identifier: NCT01861197    
Other Study ID Numbers: 2012-09-070-002
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013
Keywords provided by Myung-Ju Ahn, Samsung Medical Center:
Squamous NSCLC