Solid TumorPhase 2NCT02447419
Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors
A Phase 2 study testing Gefitinib in people with Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors. Gefitinib 250 mg will be administered orally daily. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Dec 2014to 1 Dec 2020
- 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
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
- (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
- ECOG performance status 0-2.
- Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
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- Adequate Organ Function Laboratory Values
- Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
- bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
- creatinine ≤1.5 x UNL
- Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
- Adequate heart function.
Who cannot join
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- Has known active central nervous system (CNS) metastases.
- Has an active infection requiring systemic therapy.
- Pregnancy or breast feeding
- Patients with cardiac problem.
- KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
- Any previous treatment with Gefitinib
- Patients with a risk factor of interstitial lung disease
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
Gefitinib 250 mg will be administered orally daily.
To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
- Conditions
- Solid Tumor
- Being tested
- Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Gefitinib 250mg will be administered orally daily
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib | Experimental | Gefitinib 250 mg will be administered orally daily Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: up too 100 weeks
Secondary outcomes (3)
progression-free survival
Measured: expected average of 24 weeks
overall survival
Measured: up too 100 weeks
Number of subjects with Adverse Events as a measure of safety
Measured: up too 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start3 Dec 2014
- Primary completionJun 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447419
- Sponsor's protocol ID
- 2014-10-029
- Status last verified
- Jun 2022
- First submitted
- 14 May 2015
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Byeon S, Hong JY, Lee J, Nam DH, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Use of Gefitinib in EGFR-Amplified Refractory Solid Tumors: An Open-Label, Single-Arm, Single-Center Prospective Pilot Study. Target Oncol. 2020 Apr;15(2):185-192. doi: 10.1007/s11523-020-00706-0.
PubMed 32107712
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT02447419
- Acronym / sponsor ID
- 2014-10-029
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 18 May 2015 (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.
This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
Gefitinib 250 mg will be administered orally daily.
To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib | Experimental | Drug: GefitinibGefitinib 250 mg will be administered orally daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
- (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
- ECOG performance status 0-2.
Key exclusion criteria (8 listed)
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- Has known active central nervous system (CNS) metastases.
- Has an active infection requiring systemic therapy.
- Pregnancy or breast feeding
- Patients with cardiac problem.
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 |
|---|---|---|
| GefitinibGefitinib 250mg will be administered orally daily | Drug | Gefitinib |
Primary outcome
overall response rate
Time frame: up too 100 weeks
3 secondary outcomes
progression-free survival
Time frame: expected average of 24 weeks
overall survival
Time frame: up too 100 weeks
Number of subjects with Adverse Events as a measure of safety
Time frame: up too 100 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 32107712Byeon S, Hong JY, Lee J, Nam DH, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Use of Gefitinib in EGFR-Amplified Refractory Solid Tumors: An Open-Label, Single-Arm, Single-Center Prospective Pilot Study. Target Oncol. 2020 Apr;15(2):185-192. doi: 10.1007/s11523-020-00706-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gefitinib in people with Solid Tumor, 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: up too 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447419, which also lists 1 linked publication.
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 15 Jun 2022.