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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3346 | TBD Compound 3 Wiki | 0.45 |
| drug2388 | PF-07104091 monotherapy Wiki | 0.45 |
| drug876 | Continuation of ACEi/ARB Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4114 | standard chemotherapy Wiki | 0.45 |
| drug872 | Conjunctival swab and nasopharyngeal swab Wiki | 0.45 |
| drug3782 | anti-CD40 antibody (CDX-1140) Wiki | 0.45 |
| drug2483 | Phone Administration of Questionnaires Wiki | 0.45 |
| drug873 | Connected devices measurements Wiki | 0.45 |
| drug2386 | PF-07104091 + palbociclib Wiki | 0.45 |
| drug1072 | Discontinuation of ACEi/ARB Wiki | 0.45 |
| drug2854 | Remain COVID Free SSI Wiki | 0.45 |
| drug134 | AZD1390 Wiki | 0.45 |
| drug875 | Contain COVID Anxiety SSI Wiki | 0.45 |
| drug3345 | TBD Compound 2 Wiki | 0.45 |
| drug2387 | PF-07104091 + palbociclib + letrozole Wiki | 0.45 |
| drug3564 | UCPVax + Nivolumab Wiki | 0.45 |
| drug2983 | SBRT Wiki | 0.45 |
| drug2304 | Olaparib Oral Tablet [Lynparza] Wiki | 0.45 |
| drug3344 | TBD Compound 1 Wiki | 0.45 |
| drug869 | Computerized Talking Touchscreen Wiki | 0.45 |
| drug1281 | FLT3 Ligand (CDX-301) Wiki | 0.45 |
| drug3738 | YH25448 Wiki | 0.45 |
| drug2798 | Radiotherapy Wiki | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008175 | Lung Neoplasms NIH | 0.57 |
| D055752 | Small Cell Lung Carcinoma NIH | 0.32 |
| D010051 | Ovarian Neoplasms NIH | 0.26 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.77 |
| HP:0100526 | Neoplasm of the lung HPO | 0.34 |
Navigate: Correlations HPO
There are 5 clinical trials
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 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 YH25448 after administration of single dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD) Time: Up to 2 yearsDescription: Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD) Time: Up to 2 yearsDescription: Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 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 yearsLung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide. The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches. The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients. Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).
Description: PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.
Measure: 6 months Progression-Free Survival (PFS) rate Time: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)The purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.
Description: Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4
Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows: Time: up to 8 weeks after initiation of study therapyDescription: Length of time that patient survives from time of study registration
Measure: Overall survival (OS) duration Time: From date of registration until the date of death from any cause, assessed up to 2 yearsDescription: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.
Measure: Radiographic responses using descriptive statistics Time: From date of registration, assessed up to 4 monthsDescription: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning
Measure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer) Time: 1 yearDescription: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.
Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire) Time: 1 yearDescription: Average daily step counts
Measure: Daily step count using descriptive statistics Time: 1 yearCONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.
Description: Dose-limiting toxicities (DLTs), within 13.5 months of starting radiotherapy, in order to establish the Recommended Phase II Dose (RP2D) of each DDRi-RT combination.
Measure: Dose limiting Toxicities Time: 13.5 months after start of radiotherapyDescription: Safety will be reported based on the occurrence of SAEs, SARs and SUSARs. Toxicity will be reported based on adverse events, as graded by CTCAE V5.0, and determined by routine clinical assessments at each centre.
Measure: Safety and toxicity Time: 2 years after end of RTDescription: Treatment compliance will be measured by overall radiotherapy treatment time and delays, omissions and reductions to treatment doses (both DDRi and RT).
Measure: Treatment compliance Time: End of trial treatment (DDRi and RT)Description: Best overall response will be measured as the best response (complete response, partial response or stable disease) recorded until disease progression, reported up to 2 years post-RT. This will be assessed using RECIST 1.1
Measure: Best overall response Time: 2 years after end of RTDescription: This will be assessed using the Green Criteria. Disease Control includes either the complete disappearance of all evidence of malignant disease or residual radiographic abnormalities assessed by chest CT scan at 3 and 6 months after completion of RT, which then remains stable for an additional 6 months or more and which then qualifies as controlled local disease.
Measure: Disease control Time: 2 years after end of RTDescription: Participants who have not progressed at the time of analysis will be censored at the last date they were known to be alive and progression free
Measure: Progression-free survival Time: 2 years post-RTDescription: Participants who have not died at the time of analysis will be censored at the last date they were known to be alive
Measure: Overall survival Time: 2 years post-RTDescription: Health Related Quality of Life will be determined using EORTC QLQ-C30, IL-73 and IL-74
Measure: Changes in Health Related Quality of Life Time: 2 years after end of RTDescription: Objective response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy. The proportion of patients with evaluable scans that achieve at least a partial response, as defined by RECIST v1.1(31), will be presented with 95% confidence intervals.
Measure: Objective response rate Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Assessment of mutations in components of DDR pathway in archival tumour and cfDNA prior to therapy Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Assessment of T cells within the archival tumour specimens Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Changes in cfDNA during and following treatment with DDRi-RT compared to RT alone. Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Changes in circulating biomarkers of cardiac and respiratory toxicity during and following treatment with DDRi-RT compared to RT alone. Time: 3 months post end of RTDescription: Exploratory endpoint
Measure: Changes in circulating peripheral T cell sub-sets during and following treatment with DDRi-RT compared to RT alone. Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Changes in lung parenchyma during and following treatment with DDRi-RT compared to RT alone. Time: 2 years after end of RTTo assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.
Description: Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle Time: 28 daysDescription: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
Measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
Measure: Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
Measure: Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Measure: To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
Measure: To evaluate the preliminary antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose expansion Time: From baseline through disease progression or study completion (approximately 2 years)Description: Peak concentration of PF-07104091 during selected cycles
Measure: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: Time to peak concentration of PF-07104091 during selected cycles
Measure: Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 will be calculated at selected cycles
Measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091 Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Area under the curve of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Maximum plasma concentration of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of CR or PR using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation Time: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)Description: Time from first assessment of event endpoint to last assessment of using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints Time: From baseline through time to event on study or study completion (approximately 2 years)Alphabetical 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