Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations.
Description: ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours [RECIST] 1.1) that is confirmed at least 4 weeks later.
Measure: Cohort A: Objective response rate (ORR) by response evaluation ceiteria in solid tumours (RECIST) version 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: Composite response rate is defined as the investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and prostate cancer working group 3 (PCWG3) for bone lesions, prostate specific antigen (PSA) decline, and/or circulating tumour cell [CTC] conversion.
Measure: Cohort B: Composite response rate by RECIST version 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: DoR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.
Measure: Cohort A: Duration of response (DoR) by RECIST version 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: PFS is defined as the time from start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression.
Measure: Cohort A: Progression free survival (PFS) by RECIST version 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: Radiological ORR is defined as the percentage of participants with a confirmed response of CR or PR in their soft tissue and visceral lesions assessed by RECIST 1.1 in the absence of bone progression assessed by PCWG3.
Measure: Cohort B: ORR by RECIST version 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: Conversion of CTC count is defined as a conversion from unfavourable at baseline (≥ 5/7.5 mL blood) to favourable post-baseline (< 5/7.5 mL blood). The percentage of participants with CTC count conversion based on those with unfavourable CTC at baseline, will be presented for this study.
Measure: Cohort B: Proportion of participants with confirmed CTC count conversion from unfavourable to favourable Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: Proportion of participants with a PSA decline of ≥ 50% confirmed by a second consecutive measurement at least 3 weeks later.
Measure: Cohort B: Proportion of participants with confirmed prostate specific antigen (PSA) decline ≥ 50% Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: rPFS is defined as the time from the start of treatment until the date of objective radiographic disease progression or death.
Measure: Cohort B: Radiological progression free survival (rPFS) by RECIST 1.1 Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: Change in tumour size will be determined.
Measure: Cohort A and Cohort B: Percentage change in tumour size Time: From Screening (Day -28 to -1) until disease progression or withdrawal of consent (upto approximately 3 years)Description: To assess the safety and tolerability profile of ceralasertib.
Measure: Cohort A and B: Number of participants with serious and non-serious adverse events Time: From screening (Day -28 to -1) until 30 days after last doseAlphabetical 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