A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in NSCLC Patients Treatment
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| ClinicalTrials.gov Identifier: NCT01994057 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2013
Last Update Posted : November 10, 2020
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Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Guan shaoxing, PHD, Sun Yat-sen University
| Tracking Information | |||||||||
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| 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 |
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.
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| Original Primary Outcome Measures |
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.
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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 .
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Number of patients with ADR [ Time Frame: one month, three month ] Such as rash
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| 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 |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | locally advanced or metastatic NSCLC (non-small cell lung cancer) patients; administrated with gefitinib,erlotinib . | ||||||||
| Condition |
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| 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 |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment |
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. |
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| Sex/Gender |
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| Ages | 18 Years to 85 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 ) |
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| 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 |
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| PRS Account | Sun Yat-sen University | ||||||||
| Verification Date | November 2020 | ||||||||