Solid TumorNCT03258099
Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
An observational study of Solid Tumor and Capecitabine, run by Cui Yimin at 7 sites in China.
Trial summary
Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Capecitabine, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- detection of genotype
- How many people
- 2,200 participants
- Where
- 7 sitesChina
- Study dates
- 28 Dec 2017to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese solid tumor patients with the treatment of capecitabine-based chemotherapy.
Who may be able to join
- Any native Chinese men or women at least 18 years of age;
- Sign informed consent of the research;
- Have a histologic or cytologic diagnosis of solid tumor;
- Will receive capecitabine-based chemotherapy; Or patients who received capecitabine chemotherapy meet the inclusion and exclusion criteria of the research, and their clinical information is complete to obtain;
- Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after discontinuation of study treatment.Women with childbearing potential must have a negative pregnancy test within 7 days prior to study enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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- Have discontinued all previous therapies for cancer for at least 28 days prior to study entry, and have recovered from the acute effects of therapy.
- Have adequate organ function, including:
- Bone marrow reserve:
- ANC≥1.5×109/L
- PLT≥100×109/L
- HGB≥10g/dL
- Hepatic:
- Bilirubin ≤ 1.5ULN
- ALT, AST ≤2.5 ULN, ≤5ULN when liver metastases are known.
- Renal: Src ≤1.5mg/dl
- Electrolytes: Patients may be entered into the study if, in the investigators' opinion, any electrolyte disorders, including K<3.4mEq/L, Ca<8.4mEq/L, or Mg<1.2mEq/l, may be appropriately managed and stabilized by the time of the laboratory evaluation prior to the chemotherapy. If electrolytes have not been stabilized during this time, the patient will be discontinued from the study.
- Have an estimated life expectancy, in the judgment of the investigator, which will permit the patient to complete the PK phase and at least 2 cycle of the evaluation of the toxicities.
Who cannot join
- Serious concomitant systemic disorder, including active infection, which is incompatible with the study (at the discretion of the investigator).
- History of human immunodeficiency virus, hepatitis B, or hepatitis C infections.
- Cardiac: Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. It is recommended that patients with arrhythmias (persistent or paroxysmal ventricular or supraventricular arrhythmias, including atrial fibrillation or bradycardia (heart rate <50 beats per minute))be excluded at the investigator's discretion.
- Known family history of unexplained sudden death.
- Personal history of unexplained syncope within the last year.
- Patients with complete gastrectomy or other significant gastrointestinal diseases that, in the investigator's opinion, may significantly impact drug absorption.
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- Inability to swallow tablets.
- Women who are breast feeding, lactating, or pregnant.
- Patients with known allergies to capecit and its supplementary materials.
- Drugs and herbal supplements that are known to be potent or moderate inhibitors or inducers of cytochrome P450 (CYP) are specifically excluded. Foods that are known to be potent or moderate inhibitors of CYP are also specifically excluded during the study.
- Patients receiving herbal regimens.
- Use of drugs with narrow therapeutic windows that are also known substrates of CYP2C9.
- Patients with DPYD deficiency.
- History of administration Usevir or its analogs within 28 days.
- Patients with severe renal impairment (CrCl <30ml/min)
- Failure for any reason to satisfy the investigator for adequate fitness to participated in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Fuling Center Hospital of Chongqing City
Chongqing, Chongqing Municipality, 408000
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of capecitabine in toxicities, through the pharmacogenomics research.
The aim of this study is to evaluating the association genetic polymorphisms with capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of capecitabine and provide scientific basis for precise medication guide for people to use capecitabine.
- Conditions
- Solid Tumor, Capecitabine, Drug-Related Side Effects and Adverse Reactions, Pharmacogenetics, Pharmacokinetics
- Being tested
- detection of genotype
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of genotypeGenetic
detection of genotype by next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| wild genotype | Through next generation sequencing, distinguish wild genotype of capecitabine Receives: Genetic: detection of genotype | |
| mutant genotype | Through next generation sequencing, distinguish mutant genotype of capecitabine Receives: Genetic: detection of genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe diarrhea toxicity
The toxicity induced by capecitabine-based chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Patients with grade 3-4 adverse events will be considered as having severe toxicity. At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
Measured: At 1 year
Incidence of severe hand-foot syndrome toxicity
The toxicity induced by capecitabine-based chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Patients with grade 3-4 adverse events will be considered as having severe toxicity. At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
Measured: At 1 year
Secondary outcomes (4)
Incidence of other severe toxicities
The other toxicities induced by capecitabine-based chemotherapy during observation time, including gastrointestinal toxicity, neurotoxicity, hematological toxicity etc., will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Toxicities with grade 3-4 will be considered as severe toxicity, except for severe neurotoxicity (grade 2-3). At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
Measured: At 1 year
Genotyping
Collect blood specimen, then detect genotype by next generation sequencing.
Measured: Before chemotherapy
The kinds of the metabolites
Determine the metabolic profiles of capecitabine. This outcome is not applicable to patients retrospectively collected.
Measured: Pre-dose and 3 hours after the last administration in the first cycle
Area under the curve [AUC]
Determine the AUC of capecitabine and its metabolites. This outcome is not applicable to patients retrospectively collected.
Measured: Pre-dose and 3 hours after the last administration in the first cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start28 Dec 2017
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258099
- Sponsor's protocol ID
- 2016[1239]-1
- Status last verified
- Aug 2019
- First submitted
- 17 Aug 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT03258099
- Acronym / sponsor ID
- 2016[1239]-1
- Conditions
- Solid Tumor, Capecitabine, Drug-Related Side Effects and Adverse Reactions, Pharmacogenetics, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Aug 2017 (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.
Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of capecitabine in toxicities, through the pharmacogenomics research.
The aim of this study is to evaluating the association genetic polymorphisms with capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of capecitabine and provide scientific basis for precise medication guide for people to use capecitabine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wild genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish wild genotype of capecitabine |
| mutant genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish mutant genotype of capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese solid tumor patients with the treatment of capecitabine-based chemotherapy.
Key inclusion criteria (18 listed)
- Any native Chinese men or women at least 18 years of age;
- Sign informed consent of the research;
- Have a histologic or cytologic diagnosis of solid tumor;
- Will receive capecitabine-based chemotherapy; Or patients who received capecitabine chemotherapy meet the inclusion and exclusion criteria of the research, and their clinical information is complete to obtain;
- Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after discontinuation of study treatment.Women with childbearing potential must have a negative pregnancy test within 7 days prior to study enrollment;
Key exclusion criteria (16 listed)
- Serious concomitant systemic disorder, including active infection, which is incompatible with the study (at the discretion of the investigator).
- History of human immunodeficiency virus, hepatitis B, or hepatitis C infections.
- Cardiac: Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. It is recommended that patients with arrhythmias (persistent or paroxysmal ventricular or supraventricular arrhythmias, including atrial fibrillation or bradycardia (heart rate <50 beats per minute))be excluded at the investigator's discretion.
- Known family history of unexplained sudden death.
- Personal history of unexplained syncope within the last year.
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 |
|---|---|---|
| detection of genotypedetection of genotype by next generation sequencing | Genetic | mutant genotype, wild genotype |
Primary outcome
Incidence of severe diarrhea toxicity
Time frame: At 1 year
The toxicity induced by capecitabine-based chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Patients with grade 3-4 adverse events will be considered as having severe toxicity. At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
Incidence of severe hand-foot syndrome toxicity
Time frame: At 1 year
The toxicity induced by capecitabine-based chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Patients with grade 3-4 adverse events will be considered as having severe toxicity. At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
4 secondary outcomes
Incidence of other severe toxicities
Time frame: At 1 year
Genotyping
Time frame: Before chemotherapy
The kinds of the metabolites
Time frame: Pre-dose and 3 hours after the last administration in the first cycle
Area under the curve [AUC]
Time frame: Pre-dose and 3 hours after the last administration in the first cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Capecitabine, run by Cui Yimin at 7 sites 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 18 inclusion and 16 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Incidence of severe diarrhea toxicity (time frame: At 1 year). The study lists 2 primary outcomes in all. 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 Aug 2019.