Non-small Cell Lung CancerPhase 2NCT01017679
Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg
A Phase 2 study testing Gefitinib 500mg/Gefitinib 250mg in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gefitinib 500mg/Gefitinib 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- received at least one chemotherapy regimen
- with stable disease after a month treatment of gefitinib(CT scan)
- the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
- Age >18 years, either sex
- with a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
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- WHO performance status(PS)<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)
- N>=1.5×109/L, Plt>=1.5×109/L,Hb>=10g/dL
- ALP<2.5×ULN.If ALP>=2.5ULN, AST\&ALT should <1.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN，AST\&ALT<2.5ULN(without liver metastasis) or <5ULN (with liver metastasis).
- Signed and dated informed consent before the start of specific protocol procedures.
- recruiting and receiving treatment in 5 days after last CT scan
- Patients able to taken oral drug
Who cannot join
- Life expectancy <= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
- experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
- can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
- allergic to gefitinib
- Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
- Pregnant or breast-feeding women
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Phase II Multi-centre Randomized Controlled Study of Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg
This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gefitinib 500mg/Gefitinib 250mg
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib 500mg/Gefitinib 250mgDrug
Also called Iressa
Gefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Drug gefitinib(Iressa) 500 mg Everyday Receives: Drug: Gefitinib 500mg/Gefitinib 250mg |
| 2 | Active comparator | Oral Drug gefitinib(Iressa) 250 mg Everyday Receives: Drug: Gefitinib 500mg/Gefitinib 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the difference of Response rate(CR & PR)
Measured: 3 years
Secondary outcomes (1)
Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms
Measured: 3 and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017679
- Sponsor's protocol ID
- 08-JC-003
- Status last verified
- Jan 2012
- First submitted
- 10 Nov 2009
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-centre Randomized Controlled Study of Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg
- ClinicalTrials.gov ID
- NCT01017679
- Acronym / sponsor ID
- 08-JC-003
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- May 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Nov 2009 (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 is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gefitinib 500mg/Gefitinib 250mgOral Drug gefitinib(Iressa) 500 mg Everyday |
| 2 | Active comparator | Drug: Gefitinib 500mg/Gefitinib 250mgOral Drug gefitinib(Iressa) 250 mg Everyday |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- received at least one chemotherapy regimen
- with stable disease after a month treatment of gefitinib(CT scan)
- the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
- Age >18 years, either sex
Key exclusion criteria (8 listed)
- Life expectancy <= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
- experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
- can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
- allergic to gefitinib
- Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
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 |
|---|---|---|
| Gefitinib 500mg/Gefitinib 250mgAlso: IressaGefitinib 500mg or 250mg is Taken Orally everyday by Experimental and controlled Arms respectively | Drug | 1, 2 |
Primary outcome
Comparing the difference of Response rate(CR & PR)
Time frame: 3 years
1 secondary outcome
Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms
Time frame: 3 and a half years
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 10 Dec 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.
Li Zhang, MD principal investigator
Sun Yat-sen University
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 500mg/Gefitinib 250mg in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
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 10 Dec 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 China. 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?
Comparing the difference of Response rate(CR & PR) (time frame: 3 years). 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 10 Dec 2013.