A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment
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|ClinicalTrials.gov Identifier: NCT03092128|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : September 13, 2018
|Condition or disease|
|Gastrointestinal Stromal Tumors Germline Mutation Somatic Mutation Plasma Concentration|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Retrospective Study Based on Pharmacokinetics, Somatic Mutations and Genetic Polymorphisms Related to Individual Variations of Drug Effect and Adverse Drug Reaction of Imatinib in Gastrointestinal Stromal Tumor Treatment.|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
sensitive group; non-sensitive group
sensitive patients were defined as patients reached CR or PR after first month administration,SD after first three months administration. non-sensitive patients were defined as patients reached PD after first month administration and first three months administration.
- Progression free survival [ Time Frame: The time from the date of randomisation (baseline) to the date of objective tumour progression，and expected average of 36 months. ]Excluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.
- Number of patients with objective response and adverse events [ Time Frame: one month, three month, 12 month ]Objective responses (complete response plus partial response) and disease control (objective response plus stable disease≥6 weeks) were established according to RECIST.And adverse events was established according to CTCAE.
Biospecimen Retention: Samples With DNA
- FFPE samples of tissue needle biopsy were used for KIT and PDGFRA mutation detection.
- EDTA-whole blood was centrifuged at 4000rpm*10min,plasma was separated within four hours for somatic mutation detection.The remaining samples were used for germline mutation detection. All the blood samples were frozen in -80℃ until analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092128
|Contact: Wei Zhuang, Ph.Dfirstname.lastname@example.org|
|Contact: Min Huang, Professor||86-020-39943027||Huangmin@mail.sysu.edu.cn|
|Institute of Clinical Pharmacology, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Wei Zhuang, Ph. D 86-13427526343 email@example.com|
|Contact: Min Huang, Professor +86 020 87331409 ext 101 firstname.lastname@example.org|
|Study Chair:||Min Huang, Professor||Institute of Clinical Pharmacology, SunYat-senU|