SNPMiner Trials (Home Page)
Report for Clinical Trial NCT04072042
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Biomarker Driven, Open Label, Phase II Study of VEGFR2 Inhibitor Apatinib in Patients With Recurrent or Refractory Advanced Bone and Soft Tissue Sarcoma
The aim of this study is to evaluate the efficacy and safety of Apatinib monotherapy for relapsed or refractory advanced bone and soft tissue sarcoma with VEGFR-2 (KDR) 604A>G polymorphism as predictive biomarker
NCT04072042 Sarcoma MeSH: Sarcoma
HPO: Sarcoma Soft tissue sarcoma
1 Interventions
Name: Apatinib monotherapy
Description: patients will receive Apatinib 250mg tablet by mouth, bid.Type: DrugApatinib monotherapy
Primary Outcomes
Description: The proportion of patients that are progression-free according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Measure: progression free rate (PFR) Time: 4 months from recruitmentSecondary Outcomes
Description: The proportion of patients with negative biomarker that are progression-free according to RECIST 1.1
Measure: progression free rate (PFR) in biomarker negative sub-cohort Time: 4 months from recruitmentDescription: The difference of PFS between biomarker positive and biomarker negative sub-cohorts with log-rank test
Measure: progression free survival(PFS) between biomarker positive and negative sub-cohorts Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsDescription: Correlation of KDR 604 AA，AG，GG genotype with the incidence of pulmonary lesion cavitation or pneumothorax among all comers
Measure: Correlation of KDR polymorphism with pulmonary lesion cavitation/pneumothorax Time: 4 months from recruitmentDescription: Correlation of KDR 604 AA，AG，GG genotype with the incidence of hair depigmentation among all comers
Measure: Correlation of KDR polymorphism with hair depigmentation Time: 4 months from recruitmentDescription: Correlation of KDR 604 AA，AG，GG genotype with progression free survival according to RECIST 1.1 among all comers
Measure: Correlation of KDR polymorphism with progression-free survival(PFS) Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsDescription: The occurrence of each adverse events(AEs), severe AEs(SAEs) and death according the CTCAE_5.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: through study completion, an average of 8 monthsDescription: Correlation of CSF1R (rs10079250) genotype with the incidence of wound complications among all comers
Measure: Correlation of CSF1R polymorphism (rs10079250) with wound complication Time: through study completion, an average of 8 monthsDescription: Correlation of PDGFRα (rs35597368) genotype with the incidence of hand foot skin reaction among all comers
Measure: Correlation of PDGFRα polymorphism (rs35597368) with hand foot skin reaction Time: through study completion, an average of 8 monthsDescription: to correlate the incidence of targeted therapy related AEs （pulmonary lesion cavitation, pneumothorax, hair depigmentation) with the PFS
Measure: Early identification of AEs as predictive biomarker Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsOther Outcomes
Description: The PFS for each subgroups in terms of clinicopathological characteristics (age, gender, histological type, solitary or multiple metastases, unilateral or bilateral metastases, early or late metastases, calcifying or non-calcifying lesions, with or without lesion cavitation, with or without AEs [especially pneumothorax, hand-foot skin reactions, hair depigmentation], etc
Measure: Exploratory outcome: Subgroup analysis of progression-free survival(PFS) Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsDescription: To explore the molecular basis underlying the difference of biomarker positive and negative sub-cohorts using next generation sequencing
Measure: Exploratory outcome: the molecular analysis of tumor sample Time: through study completion, an average of 8 monthsDescription: to compare the growth pattern/ distribution of pulmonary versus extrapulmonary lesion at baseline and at disease progression between the two sub-cohorts
Measure: Exploratory outcome: the pattern of disease progression between the sub-cohorts Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsDescription: to compare the diagnostic value of the 1.0 mm versus 5.0 mm CT scan for the radiological evaluation of small lung nodule as tumor recurrence
Measure: Exploratory outcome: 1.0-mm CT scan for pulmonary assessment Time: Baseline until disease progression or death, whichever occurs first, assessed for an average of 8 monthsPurpose: Treatment
Single Group Assignment
There are 3 SNPs
SNPs
1 rs10079250
Correlation of CSF1R polymorphism (rs10079250) with wound complication.
Correlation of CSF1R (rs10079250) genotype with the incidence of wound complications among all comers.
2 rs20715592
Our preliminary data suggests that rs2071559_VEGFR2 604A>G polymorphism is associated pulmonary tumor cavitation (predisposes one to pneumothorax), hair depigmentation, superior efficacy and less likelihood of extra-pulmonary lesion.
3 rs35597368
Correlation of PDGFRα polymorphism (rs35597368) with hand foot skin reaction.
Correlation of PDGFRα (rs35597368) genotype with the incidence of hand foot skin reaction among all comers.