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Name (Synonyms) | Correlation | |
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drug1096 | Comprehensive treatment Wiki | 0.71 |
drug1117 | Control (albumin 5%) Wiki | 0.71 |
drug1137 | Convalescent Plasma (anti-SARS-CoV-2 plasma) Wiki | 0.50 |
Name (Synonyms) | Correlation | |
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D002289 | Carcinoma, Non-Small-Cell Lung NIH | 0.29 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D018352 | Coronavirus Infections NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0030358 | Non-small cell lung carcinoma HPO | 0.29 |
Navigate: Correlations HPO
There are 2 clinical trials
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of Lazertinib when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
Description: An adverse event is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measure: Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability Time: Up to 2 yearsDescription: Plasma Concentration of Lazertinib after administration of single dose will be evaluated.
Measure: Part D: Plasma Concentration of Lazertinib After Administration of Single Dose (SD) Time: Up to 2 yearsDescription: Plasma Concentration of Lazertinib after administration of multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of Lazertinib After Administration of Multiple Dose (MD) Time: Up to 2 yearsDescription: Plasma Concentration of Lazertinib metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of Lazertinib Metabolites (M6 and M7) After Administration of Single and Multiple Dose Time: Up to 2 yearsDescription: ORR is defined as the percentage of participants who have at least one confirmed Partial response (PR) or Complete response (CR) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) prior to disease progression or recurrence. CR is defined when all target lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception of lymph nodes which must be less than (<)10 millimeters (mm) to be considered non-pathological) and no new lesions have developed since baseline. PR is defined when the sum of diameters of the TLs has decreased by 30 percent (%) or more compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions.
Measure: Part D: Overall Response Rate (ORR) Time: Up to 2 yearsDescription: DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.
Measure: Part D: Duration of Response (DoR) Time: Up to 2 yearsDescription: DCR is defined as the percentage of participants with a best overall, extracranial and intracranial response of CR, PR or Stable Disease (SD). CR is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. PR is defined as At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm for extracranial and intracranial lesion, respectively.
Measure: Part D: Disease Control Rate (DCR) Time: Up to 2 yearsDescription: Tumor shrinkage is measured at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline measured as greater than or equal to (>=) 10 mm in the longest lesion diameter with computed tomography (CT) or magnetic resonance imaging (MRI).
Measure: Part D: Tumor Shrinkage Time: Up to 2 yearsDescription: PFS is defined as the time from first dosing date until documented disease progression or death from any cause whichever occur first based on investigator assessment using RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm for extracranial and intracranial lesion, respectively.
Measure: Part D: Progression Free Survival (PFS) Time: Up to 2 yearsDescription: OS is defined as the interval between the date of first dose and the date of participants death due to any cause.
Measure: Part D: Overall Survival (OS) Time: Up to 2 yearsThe purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
Description: Cmax is defined as maximum plasma concentration.
Measure: Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib Time: Predose up to 120 hours post doseDescription: %AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.
Measure: Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib Time: Predose up to 120 hours post doseDescription: An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Measure: Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Time: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports