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A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in NSCLC Patients Treatment

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ClinicalTrials.gov Identifier: NCT01994057
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Guan shaoxing, PHD, Sun Yat-sen University

Tracking Information
First Submitted Date November 1, 2013
First Posted Date November 25, 2013
Last Update Posted Date November 10, 2020
Study Start Date September 2013
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2020)
Progression free survival [ Time Frame: The length of time from either the date of diagnosis to that patients diagnosed with the disease are still alive ]
Excluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.
Original Primary Outcome Measures
 (submitted: November 20, 2013)
Progression free survival [ Time Frame: the time from the date of randomisation (baseline) to the date of objective tumour progression,an expected average of 12 months ]
Excluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2013)
Number of patients with objective response and adverse events [ Time Frame: one month, three 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 NCI-CTC .
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2019)
Number of patients with ADR [ Time Frame: one month, three month ]
Such as rash
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in NSCLC Patients Treatment
Official Title Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.
Brief Summary For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.
Detailed Description The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  1. FFPE samples of tissue needle biopsy were used for EGFR mutation detection.
  2. 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.
Sampling Method Non-Probability Sample
Study Population locally advanced or metastatic NSCLC (non-small cell lung cancer) patients; administrated with gefitinib,erlotinib .
Condition
  • Non-small Cell Lung Cancer (NSCLC)
  • EGFR-TKI Resistant Mutation
  • EGFR-TKI Sensitizing Mutation
  • Germline Mutations
  • Somatic Mutation
Intervention Not Provided
Study Groups/Cohorts sensitive group; resistant group

sensitive patients were defined as patients reached CR or PR after first month administration,SD after first three months administration.

resistant patients were defined as patients reached PD after first month administration and first three months administration

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 28, 2019)
1000
Original Estimated Enrollment
 (submitted: November 20, 2013)
200
Estimated Study Completion Date December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:

uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shaoxing Guan, PHD +86 13129351756 ext +8613129351756 guanshx3@mail2.sysu.edu.cn
Contact: Min Huang, Professor +86 020 87331409-101 huangmin@mail.sysu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01994057
Other Study ID Numbers 2012ZX09506001-004 (2)
(2) ( Other Identifier: China: National Natural Science Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Guan shaoxing, PHD, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators
Study Chair: Min Huang, Professor school of pharmaceutical sciences , SunYat-senU
PRS Account Sun Yat-sen University
Verification Date November 2020