Non-small Cell Lung CancerPhase 4NCT01720901
Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
A Phase 4 study testing Icotinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2016
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
- Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
- Signed and dated informed consent before the start of specific protocol procedures.
Who cannot join
- Allergic to icotinib.
- Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Read the detailed description
This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib
- 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.
IcotinibDrug
Also called Conmana, BPI-2009
Icotinib will be administered 250 mg one time by month, 3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Icotinib will be administered 250 mg one time by month, 3 times per day. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
Measured: 4.5 months
Secondary outcomes (3)
Overall survival
Overall survival is a duration from the date that first dose is given to the date of death.
Measured: 12 months
Tumor response
Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.
Measured: 6 weeks
Adverse Events
Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Accrual limitations
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 Betta Pharmaceuticals Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Chengping, M.D., Principal investigator, Xiangya Hospital, Central-South Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720901
- Sponsor's protocol ID
- BD-IC-IV41
- Status last verified
- May 2015
- First submitted
- 31 Oct 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
- ClinicalTrials.gov ID
- NCT01720901
- Acronym / sponsor ID
- BD-IC-IV41
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Accrual limitations
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Nov 2012 (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.
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Detailed description
This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: IcotinibIcotinib will be administered 250 mg one time by month, 3 times per day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
- Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
- Signed and dated informed consent before the start of specific protocol procedures.
Key exclusion criteria (3 listed)
- Allergic to icotinib.
- Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
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 |
|---|---|---|
| IcotinibAlso: Conmana, BPI-2009Icotinib will be administered 250 mg one time by month, 3 times per day. | Drug | Icotinib |
Primary outcome
Progression-free survival
Time frame: 4.5 months
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
3 secondary outcomes
Overall survival
Time frame: 12 months
Tumor response
Time frame: 6 weeks
Adverse Events
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
Hu Chengping, M.D. principal investigator
Xiangya Hospital, Central-South Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icotinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. 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 4 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: paused, as of the sponsor's last update on 22 May 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Progression-free survival (time frame: 4.5 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 22 May 2015.