Non-small Cell Lung CancerPhase 4NCT01465243
Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose
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 determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
- Measurable, evaluable disease outside of a radiation port.
Who cannot join
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
Trial locations and contacts
1 site in 1 country.
China1 site
307 Hospital of People's Liberation Army（PLA）
Beijing, Beijing Municipality, 100071
About this study
Official title: An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy
To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.
Read the detailed description
Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib
- Keywords
- Efficacy, Safety, EGFR-TKI, phase IV, NSCLC, Dose escalation
- 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 BPI-2009, Conmana
125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | This is a single arm study. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: 6-12 months
Secondary outcomes (5)
Overall survival
Measured: 6 months -1 year
Objective response rate
Measured: 3-6 months
Time to progression
Measured: 3-6 months
Health-Related Quality of Life (HR QOL)
Measured: 1 year
Number of Participants with adverse events and serious adverse events (SAEs)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionFeb 2014
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Xi qing, M.D., Principal investigator, 307 Hospital of People's Liberation Army（PLA）
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465243
- Sponsor's protocol ID
- BD-IC-IV01
- Status last verified
- Feb 2014
- First submitted
- 1 Nov 2011
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. 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 Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy
- ClinicalTrials.gov ID
- NCT01465243
- Acronym / sponsor ID
- BD-IC-IV01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Efficacy, Safety, EGFR-TKI, phase IV, NSCLC, Dose escalation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Nov 2011 (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 determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.
Detailed description
Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.
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: IcotinibThis is a single arm study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
- Measurable, evaluable disease outside of a radiation port.
Key exclusion criteria (2 listed)
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
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: BPI-2009, Conmana125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day) | Drug | Icotinib |
Primary outcome
Progression-free Survival
Time frame: 6-12 months
5 secondary outcomes
Overall survival
Time frame: 6 months -1 year
Objective response rate
Time frame: 3-6 months
Time to progression
Time frame: 3-6 months
Health-Related Quality of Life (HR QOL)
Time frame: 1 year
Number of Participants with adverse events and serious adverse events (SAEs)
Time frame: 1 year
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 17 Feb 2014.
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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 Xi qing, M.D. principal investigator
307 Hospital of People's Liberation Army（PLA）
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 3 inclusion and 2 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 17 Feb 2014. 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?
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?
Progression-free Survival (time frame: 6-12 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 17 Feb 2014.