Non-Small Cell Lung CancerNCT02708667
An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients
An observational study of Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to May 2016
- Phase
- Observational
- 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
Study population: Patients who were diagnosed with stage III or IV non-small cell lung cancer (NSCLC), harbored ALK fusion gene and took crizotinib.
Who may be able to join
- patients who were histologically and cytologically confirmed NSCLC at stage III or IV
- harbored ALK fusion gene and took crizotinib
- age:18~75years
- Eastern cooperative oncology group performance status(ECOG PS): 0~2 points
- the expected lifetime is more than 12 weeks after being recruited
Who cannot join
- patients who also suffered from other malignant tumor
- uncontrolled systemic diseases,central nervous system (CNS) metastasis
- clinically active interstitial lung diseases
- severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
- taking drugs that interact with crizotinib
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Likun Chen, doctor, 13798019964
About this study
Official title: An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, crizotinib, hepatic toxicity
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse events
Measured: change from the date of taking crizotinib at 9 months
Secondary outcomes (1)
progression free survival
Measured: from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-kun Chen, Sun Yat-sen University
- Investigators
- Likun Chen, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708667
- Sponsor's protocol ID
- 2015-FXY-078-Internal medicine
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02708667
- Acronym / sponsor ID
- 2015-FXY-078-Internal medicine
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, crizotinib, hepatic toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 15 Mar 2016 (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.
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with stage III or IV non-small cell lung cancer (NSCLC), harbored ALK fusion gene and took crizotinib.
Key inclusion criteria (5 listed)
- patients who were histologically and cytologically confirmed NSCLC at stage III or IV
- harbored ALK fusion gene and took crizotinib
- age:18~75years
- Eastern cooperative oncology group performance status(ECOG PS): 0~2 points
- the expected lifetime is more than 12 weeks after being recruited
Key exclusion criteria (5 listed)
- patients who also suffered from other malignant tumor
- uncontrolled systemic diseases,central nervous system (CNS) metastasis
- clinically active interstitial lung diseases
- severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
- taking drugs that interact with crizotinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with adverse events
Time frame: change from the date of taking crizotinib at 9 months
1 secondary outcome
progression free survival
Time frame: from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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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.
Likun Chen principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 inclusion and 5 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 15 Mar 2016. 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.
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 Likun Chen (020-87342475, chenlk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adverse events (time frame: change from the date of taking crizotinib at 9 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 15 Mar 2016.