Non Small Cell Lung CancerNCT03680183
Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)
An observational study of Non Small Cell Lung Cancer and Hepatitis B, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Hepatitis B
- What is being tested?
- Entecavir 1Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2018to 31 Dec 2021
- How long will I take part?
- 1 Year
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients diagnosed of non-small-cell lung cancer. Controlled group are HBV negative and HBV group are diagnosed of chronic hepatitis B. All subjects should be able to make their own decision and sign informed concerned.
Who may be able to join
- pathological confirmed non-small-cell lung cancer
- with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
- liver function, ALT and/or AST <= 2*upper limit of normal (ULN)
- diagnosed of chronic hepatitis B
- Hepatitis B negative as controlled group
- receiving one type of TKIs
- Age between 18-70
Who cannot join
- diagnosed of acute/ active hepatitis B
- diagnosed of AIDS
- unable to make decision because of metastasis to central nervous system
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510182
Wenying Shu, PhD, 86-20-66673666 ext. 2006, 790840799@qq.com
Tiantian Cheng, MD, 86-20-66673677, gyzlgcp@163.com
About this study
Official title: Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.
Read the detailed description
Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer, Hepatitis B
- Being tested
- Entecavir 1Mg Oral Tablet
- Keywords
- Tyrosine kinase inhibitors, pharmacokinetics, Hepatitis B
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir 1Mg Oral TabletDrug
Also called Bicyclol Tablets
The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)
| Study group | Role | What they receive |
|---|---|---|
| Pre-exposure | Entecavir 1Mg Oral Tablet Receives: Drug: Entecavir 1Mg Oral Tablet | |
| Post-exposure | Entecavir 1Mg Oral Tablet Receives: Drug: Entecavir 1Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average plasma concentration of the drugs (TKIs)
compare the concentration of TKIs prior to and after anti-HBV treatment
Measured: one year after recruit
Secondary outcomes (1)
Incidence of adverse reaction caused by TKIs
the adverse reaction of TKIs before and after anti-HBV treatment
Measured: one year after recruit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start22 May 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion31 Dec 2021 (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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian-Tian Cheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Investigators
- Shuzhong Cui, MD, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680183
- Sponsor's protocol ID
- PTKI-HBV-01
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
- ClinicalTrials.gov ID
- NCT03680183
- Acronym / sponsor ID
- PTKI-HBV-01
- Conditions
- Non Small Cell Lung Cancer, Hepatitis B
- Keywords
- Tyrosine kinase inhibitors, pharmacokinetics, Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Sep 2018 (actual)
- 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.
The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.
Detailed description
Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-exposure | – | Drug: Entecavir 1Mg Oral TabletEntecavir 1Mg Oral Tablet |
| Post-exposure | – | Drug: Entecavir 1Mg Oral TabletEntecavir 1Mg Oral Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients diagnosed of non-small-cell lung cancer. Controlled group are HBV negative and HBV group are diagnosed of chronic hepatitis B. All subjects should be able to make their own decision and sign informed concerned.
Key inclusion criteria (7 listed)
- pathological confirmed non-small-cell lung cancer
- with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
- liver function, ALT and/or AST <= 2*upper limit of normal (ULN)
- diagnosed of chronic hepatitis B
- Hepatitis B negative as controlled group
Key exclusion criteria (3 listed)
- diagnosed of acute/ active hepatitis B
- diagnosed of AIDS
- unable to make decision because of metastasis to central nervous system
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 |
|---|---|---|
| Entecavir 1Mg Oral TabletAlso: Bicyclol TabletsThe anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST) | Drug | Post-exposure, Pre-exposure |
Primary outcome
Average plasma concentration of the drugs (TKIs)
Time frame: one year after recruit
compare the concentration of TKIs prior to and after anti-HBV treatment
1 secondary outcome
Incidence of adverse reaction caused by TKIs
Time frame: one year after recruit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Shuzhong Cui, MD study director
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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 and Hepatitis B, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical 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 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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 Wenying Shu, PhD (86-20-66673666 ext. 2006, 790840799@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average plasma concentration of the drugs (TKIs) (time frame: one year after recruit). 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 28 Sep 2018.