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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3672 | Sofusa DoseConnect Wiki | 1.00 |
| drug1381 | Enbrel Wiki | 1.00 |
| drug2933 | Placebo Administration Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001172 | Arthritis, Rheumatoid NIH | 0.27 |
| D001168 | Arthritis NIH | 0.23 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001370 | Rheumatoid arthritis HPO | 0.27 |
| HP:0001369 | Arthritis HPO | 0.23 |
Navigate: Correlations HPO
There is one clinical trial.
This phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. CD24Fc binds to injured cell components and prevents inflammatory responses. CD24Fc also acts to turn off the immune system after it has been activated ("immune checkpoint"). Adding CD24Fc to standard treatment may shorten the recovery time and reduce the severity of side effects from immunotherapy.
Description: Will assess event of new AE of >= grade 3 that are outside the spectrum of immune related adverse events (irAEs) when CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) is given in cancer patients who developed grade 2-3 irAEs. Toxicity is evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system.
Measure: Incidence of new adverse event (AE) of >= grade 3 (Phase I) Time: At day 60Description: Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Recovery rate (Phase II) Time: At day 42Description: Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
Measure: Time to recovery from grade 2 or 3 irAE (Phase II) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Measure: Recovery rate (reduction of irAE by one grade) (Phase I) Time: At day 42Description: Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase II) Time: Up to 1 yearDescription: Descriptive statistics will be used to summarize use of steroids (drug, dose, duration) and other treatment for irAE.
Measure: Use of steroids and other drugs (drug, dose, duration) (Phase II) Time: Up to 1 yearDescription: The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Measure: Overall response rate after retreatment with ICI with or without CD24Fc after resolution of irAE (Phase II) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize PFS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Measure: Progression free survival (PFS) (Phase II) Time: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize OS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Measure: Overall survival (OS) (Phase II) Time: From diagnosis to death, assessed up to 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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