Gastrointestinal Stromal Tumor, MalignantNCT06628739
Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes
An observational study of Gastrointestinal Stromal Tumor, Malignant, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Imatinib (IM) has significantly enhanced the prognosis of patients (pts) with advanced gastrointestinal stromal tumors (GISTs). The clinical outcomes may correlate with IM exposure. However, the efficacy threshold, particularly based on different primary KIT mutant, remains undefined. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrointestinal Stromal Tumor, Malignant
- What is being tested?
- Imatinib
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 May 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From July 2017 to June 2022, 168 patients with advanced GIST who received imatinib treatment regularly and had pharmacokinetic (PK) blood samples availabe were enrolled in the study.
Who may be able to join
- Histologically confirmed metastatic or recurrent GIST
- Aged 18 or older
- Treated with imatinib as first-line therapy
- Had imatinib Cmin measurement at steady state(at least one month after treatment) ≥2 times under long-term maintenance dose of regular medication
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
Who cannot join
- Poor appliance
- Important treatment data missing
- Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Correlation Between Imatinib Trough Concentration and Efficacy in Advanced Gastrointestinal Stromal Tumors Patients with Different Genotypes
Imatinib (IM) has significantly enhanced the prognosis of patients (pts) with advanced gastrointestinal stromal tumors (GISTs). The clinical outcomes may correlate with IM exposure. However, the efficacy threshold, particularly based on different primary KIT mutant, remains undefined. The objective of this study is to establish the efficacy threshold of imatinib (IM) plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.
Read the detailed description
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. The majority of GIST are driven by activating mutuations of KIT (60-70%) or platelet-derived growth factor receptor alpha (PDGFRA, 10-15%), in which KIT exon 11 mutation (52-58%) and KIT exon 9 mutation (6-9%) are the most common types of KIT mutations. Patients with different activating KIT mutations have different sensitivity to imatinib therapy. In the first-line therapy, patients with KIT exon 11 mutation receiving Imatinib with standard dose of 400mg/d has the best therapeutic effect. Patients with KIT exon 9 mutation have poor sensitivity to the standard dose of imatinib, while higher doses can lead to better outcomes. The clinical outcomes may correlate with IM exposure. However, the efficacy threshold of imatinib in Chinese patients with advanced GIST remains unclear. The investigators aim to establish the efficacy threshold of imatinib plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.
- Being tested
- Imatinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Higher or lower imatinib Cmin
The long-term maintenance dose of every patient was determined by the physician based on the guidelines and the patients' individual conditions such as adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| IM Cmin below deciles boundary | Patients with imatinib Cmin less than the decile boundary based on each imatinib Cmin distribution decile. | |
| IM Cmin above deciles boundary | Patients with imatinib Cmin greater than or equal to the decile boundary based on each imatinib Cmin distribution decile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival (PFS) was defined as time from initiation of imatinib treatment until disease progression, as assessed by Choi criteria, or death caused by any reason.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
objective response rate
Objective response rate (ORR) was defined as rate of Complete Response (CR) and Partial Response (PR).
Measured: through study completion, an average of 1 year
Overall survival
Overall survival (OS) was defined as time from initiation of imatinib treatment until death caused by any reason.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jul 2017
- Primary completion30 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal Tumor, MalignantStudies 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
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhua Zhang, MD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhang Xinhua, Professor, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628739
- Sponsor's protocol ID
- No.[2023]184
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Imatinib Trough Concentration and Efficacy in Advanced Gastrointestinal Stromal Tumors Patients with Different Genotypes
- ClinicalTrials.gov ID
- NCT06628739
- Acronym / sponsor ID
- No.[2023]184
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 8 Oct 2024 (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.
Imatinib (IM) has significantly enhanced the prognosis of patients (pts) with advanced gastrointestinal stromal tumors (GISTs). The clinical outcomes may correlate with IM exposure. However, the efficacy threshold, particularly based on different primary KIT mutant, remains undefined. The objective of this study is to establish the efficacy threshold of imatinib (IM) plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.
Detailed description
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. The majority of GIST are driven by activating mutuations of KIT (60-70%) or platelet-derived growth factor receptor alpha (PDGFRA, 10-15%), in which KIT exon 11 mutation (52-58%) and KIT exon 9 mutation (6-9%) are the most common types of KIT mutations. Patients with different activating KIT mutations have different sensitivity to imatinib therapy. In the first-line therapy, patients with KIT exon 11 mutation receiving Imatinib with standard dose of 400mg/d has the best therapeutic effect. Patients with KIT exon 9 mutation have poor sensitivity to the standard dose of imatinib, while higher doses can lead to better outcomes. The clinical outcomes may correlate with IM exposure. However, the efficacy threshold of imatinib in Chinese patients with advanced GIST remains unclear. The investigators aim to establish the efficacy threshold of imatinib plasma trough concentration (Cmin) at steady-state in Chinese patients with advanced GIST, additionally to define subgroup thresholds based on various primary KIT mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM Cmin below deciles boundary | – | –Patients with imatinib Cmin less than the decile boundary based on each imatinib Cmin distribution decile. |
| IM Cmin above deciles boundary | – | –Patients with imatinib Cmin greater than or equal to the decile boundary based on each imatinib Cmin distribution decile. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From July 2017 to June 2022, 168 patients with advanced GIST who received imatinib treatment regularly and had pharmacokinetic (PK) blood samples availabe were enrolled in the study.
Key inclusion criteria (5 listed)
- Histologically confirmed metastatic or recurrent GIST
- Aged 18 or older
- Treated with imatinib as first-line therapy
- Had imatinib Cmin measurement at steady state(at least one month after treatment) ≥2 times under long-term maintenance dose of regular medication
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
Key exclusion criteria (3 listed)
- Poor appliance
- Important treatment data missing
- Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal
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 |
|---|---|---|
| ImatinibAlso: Higher or lower imatinib CminThe long-term maintenance dose of every patient was determined by the physician based on the guidelines and the patients' individual conditions such as adverse reactions. | Drug | – |
Primary outcome
Progression free survival
Time frame: through study completion, an average of 1 year
Progression free survival (PFS) was defined as time from initiation of imatinib treatment until disease progression, as assessed by Choi criteria, or death caused by any reason.
2 secondary outcomes
objective response rate
Time frame: through study completion, an average of 1 year
Overall survival
Time frame: through study completion, an average of 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 8 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Zhang Xinhua, Professor study director
First Affiliated Hospital, Sun Yat-Sen 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 Gastrointestinal Stromal Tumor, Malignant, run by First Affiliated Hospital, 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 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: finished, as of the sponsor's last update on 8 Oct 2024. 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?
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: through study completion, an average of 1 year). 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 8 Oct 2024.