Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes

NCT06628739 | Completed

• 1 other identifier: No.[2023]184
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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. 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

Gastrointestinal Stromal Tumor, Malignant

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• objective response rate

  through study completion, an average of 1 year

• Overall survival

  through study completion, an average of 1 year

Study Arms (2)

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.

Interventions

Imatinib DRUG

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.

Also known as: Higher or lower imatinib Cmin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Poor appliance
• Important treatment data missing
• Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma for imatinib steady-state trough concentration measuring

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Zhang Xinhua, Professor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: October 8, 2024
• Study Start: July 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: May 31, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)