Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1929 | MGC018 Wiki | 0.58 |
| drug2388 | PF-07104091 monotherapy Wiki | 0.58 |
| drug876 | Continuation of ACEi/ARB Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug83 | ADCT-301 Wiki | 0.58 |
| drug853 | Community based combination HIV prevention package Wiki | 0.58 |
| drug2386 | PF-07104091 + palbociclib Wiki | 0.58 |
| drug1072 | Discontinuation of ACEi/ARB Wiki | 0.58 |
| drug2387 | PF-07104091 + palbociclib + letrozole Wiki | 0.58 |
| drug1928 | MGA012 Wiki | 0.58 |
| drug2458 | Pembrolizumab Wiki | 0.41 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055752 | Small Cell Lung Carcinoma NIH | 0.41 |
| D002292 | Carcinoma, Renal Cell NIH | 0.33 |
| D010051 | Ovarian Neoplasms NIH | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005584 | Renal cell carcinoma HPO | 0.33 |
| HP:0002894 | Neoplasm of the pancreas HPO | 0.29 |
| HP:0030731 | Carcinoma HPO | 0.20 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002664 | Neoplasm HPO | 0.11 |
Navigate: Correlations HPO
There are 3 clinical trials
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.
Description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
Measure: Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Limiting toxicities as defined per protocol, as related to ADCT-301 Time: Up to 3 yearsDescription: Adverse events will be graded according to CTAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of Adverse Events of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Serious Adverse Events (SAE) Time: Up to 3 yearsDescription: AEs will be graded according to CTCAE v.4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of SAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence or progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Overall survival (OS) defined as the time between the start of treatment and death from any cause
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Noncompartmental analysis of the maximum concentration (Cmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the time to maximum concentration (Tmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the accumulation index (AI)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of clearance (CL)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of volume of distribution (Vd)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Measure: Number of confirmed positive anti-drug antibody (ADA) responses Time: Up to 3 yearsThe purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.
Description: Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Measure: Incidence of Adverse Events of MGC018 and MGC018 + MGA012 as assessed by CTCAE v4.03 Time: 30 days after last doseDescription: Maximum tolerated or maximum administered dose of MGC018 and MGC018 + MGA012
Measure: Maximum Tolerated Dose Time: up to 42 days from first doseDescription: Efficacy assessed as best overall response rate using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measure: Preliminary anti-tumor activity of MGC018 and MGC018+MGA012 Time: 24 monthsDescription: Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA)
Measure: PSA response rate Time: 24 monthsDescription: For prostate cancer patients, time from first dose to first radiographic progression in soft tissue or bone, or death from any cause
Measure: Radiographic progression-free survival Time: 24 monthsDescription: For prostate cancer patients, change from baseline in pain intensity as measured by the Brief Pain Inventory-Short Form scale
Measure: Patient-reported Outcome Time: 24 monthsDescription: Area under the plasma concentration versus time curve of MGC018 and MGC018+MGA012
Measure: Area under the curve Time: 24 monthsDescription: Maximum Plasma Concentration of MGC018 and MGC018+MGA012
Measure: Cmax Time: 24 monthsDescription: Time to reach maximum (peak) plasma concentration of MGC018 and MGC018+MGA012
Measure: Tmax Time: 24 monthsDescription: Trough plasma concentration of MGC018 and MGC018+MGA012
Measure: Ctrough Time: 24 monthsDescription: Total body clearance of the drug from plasma of MGC018 and MGC018+MGA012
Measure: CL Time: 24 monthsDescription: Apparent volume of distribution at steady state of MGC018 and MGC018+MGA012
Measure: Vss Time: 24 monthsDescription: Terminal half life of MGC018 and MGC018+MGA012
Measure: t1/2 Time: 24 monthsDescription: Percent of patients with anti-drug antibodies against MGC018 and MGA012
Measure: Immunogenicity Time: 24 monthsTo 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