Clinical trial · Observational
Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes
Correlation Between Imatinib Trough Concentration and Efficacy in Advanced Gastrointestinal Stromal Tumors Patients with Different Genotypes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor, Malignant | Malignant Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- IM Cmin below deciles boundary
- description
- Patients with imatinib Cmin less than the decile boundary based on each imatinib Cmin distribution decile.
- label
- IM Cmin above deciles boundary
- description
- Patients with imatinib Cmin greater than or equal to the decile boundary based on each imatinib Cmin distribution decile.
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- through study completion, an average of 1 year
- description
- 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.
Secondary outcomes (2)
- measure
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Poor appliance * Important treatment data missing * Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal
References
Publications (0)
Data not yet available