Squamous NSCLCPhase 2NCT01861197
Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer
A Phase 2 study testing Dovitinib in people with Squamous NSCLC, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Efficacy of Dovitinib for Squamous NSCLC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Squamous NSCLC
- What is being tested?
- Dovitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active infection
- uncontrolled brain metastasis
- unstable angina or MI
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Myung-Ju Ahn, Ph.D., 822-3410-3459, silkahn@skku.edu
About this study
Efficacy of Dovitinib for Squamous NSCLC.
- Conditions
- Squamous NSCLC
- Being tested
- Dovitinib
- Keywords
- Efficacy, Dovitinib, Squamous NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DovitinibDrug
Dovitinib 500mg daily for 5 days on/ 2 day off until progression
| Study group | Role | What they receive |
|---|---|---|
| Dovitinib monotherapy | Experimental | Not described Receives: Drug: Dovitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous NSCLCStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
- Investigators
- Myung-Ju Ahn, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861197
- Sponsor's protocol ID
- 2012-09-070-002
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01861197
- Acronym / sponsor ID
- 2012-09-070-002
- Conditions
- Squamous NSCLC
- Keywords
- Efficacy, Dovitinib, Squamous NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (estimated)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Dovitinib for Squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dovitinib monotherapy | Experimental | Drug: Dovitinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- active infection
- uncontrolled brain metastasis
- unstable angina or MI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DovitinibDovitinib 500mg daily for 5 days on/ 2 day off until progression | Drug | Dovitinib monotherapy |
Primary outcome
response rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Ju Ahn principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dovitinib in people with Squamous NSCLC, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ju Ahn (822-3410-3459, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.