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

NCT ID: NCT01861197

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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Efficacy of Dovitinib for Squamous NSCLC.

Detailed Description

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Conditions

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Squamous NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dovitinib monotherapy

Group Type EXPERIMENTAL

Dovitinib

Intervention Type DRUG

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

Interventions

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Dovitinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Myung-Ju Ahn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myung-Ju Ahn

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myung-Ju Ahn

Role: CONTACT

822-3410-3459

Facility Contacts

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Myung-Ju Ahn, Ph.D.

Role: primary

822-3410-3459

Other Identifiers

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2012-09-070-002

Identifier Type: -

Identifier Source: org_study_id

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