NCT01861197

Brief Summary

Efficacy of Dovitinib for Squamous NSCLC.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

May 21, 2013

Last Update Submit

May 22, 2013

Conditions

Squamous NSCLC

Keywords

EfficacyDovitinibSquamous NSCLC

Outcome Measures

Primary Outcomes (1)

  • response rate

    6 months

Study Arms (1)

Dovitinib monotherapy

EXPERIMENTAL
Drug: Dovitinib

Interventions

DovitinibDRUG

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

Dovitinib monotherapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed squamous NSCLC
  • Previously treated with one or two lines of chemotherapy
  • FGFR amplification (FISH \> 5 copies of genes)
  • years or older
  • ECOG PS 0-2

You may not qualify if:

  • active infection
  • uncontrolled brain metastasis
  • unstable angina or MI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Study Officials

  • Myung-Ju Ahn

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myung-Ju Ahn

CONTACT

822-3410-3459silkahn@skku.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2015

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

KR(1)