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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug177 | AZD5069 Wiki | 0.41 |
| drug2462 | MGC018 Wiki | 0.41 |
| drug2461 | MGA012 Wiki | 0.41 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1530 | Enzalutamide 40 MG Wiki | 0.41 |
| drug2301 | Laboratory Biomarker Analysis Wiki | 0.41 |
| drug4290 | Talabostat Mesylate plus Pembrolizumab Wiki | 0.41 |
| drug4937 | enzalutamide Wiki | 0.41 |
| drug1132 | ConvP Wiki | 0.41 |
| drug1350 | Docetaxel Wiki | 0.41 |
| drug194 | Abiraterone Acetate Wiki | 0.41 |
| drug583 | Berzosertib Wiki | 0.41 |
| drug5199 | rosuvastatin Wiki | 0.41 |
| drug1612 | FFP Wiki | 0.41 |
| drug4938 | enzalutamide Placebo Wiki | 0.41 |
| drug4421 | Tildrakizumab Wiki | 0.29 |
| drug4921 | digoxin Wiki | 0.29 |
| drug913 | Carboplatin Wiki | 0.24 |
| drug3386 | Probiotic Wiki | 0.24 |
| drug1116 | Control Wiki | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011471 | Prostatic Neoplasms NIH | 1.00 |
| D018288 | Carcinoma, Small Cell NIH | 0.29 |
| D055752 | Small Cell Lung Carcinoma NIH | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030357 | Small cell lung carcinoma HPO | 0.24 |
| HP:0100634 | Neuroendocrine neoplasm HPO | 0.24 |
| HP:0030731 | Carcinoma HPO | 0.12 |
Navigate: Correlations HPO
There are 6 clinical trials
ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.
Description: The maximum dose at which no more than 1 of 6 patients at same dose level experience a drug related toxicity (DLT), as defined in the protocol.
Measure: Establish the maximum tolerated dose (MTD) in Phase I of AZD5069 administered in combination with enzalutamide at 160mg OD. Time: 12 monthsDescription: Prostate specific antigen (PSA) decline ≥ 50% criteria confirmed 4 weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell count (CTC) of ≥ 5/7.5ml blood at baseline, conversion of CTC <5/7.5ml blood nadir.
Measure: Antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase II Time: 12 monthsDescription: For disease progression (see section 3.6) the Prostate Cancer Working Group 2 (PCWG2) criteria and RECIST (v1.1) criteria will be used. Treatment failure will be defined as: Progression of soft tissue/visceral disease by RECIST (v1.1) and/or, Progression of bone disease by PCWG2 bone scan criteria and/or Progression of PSA by PCWG2 PSA criteria.
Measure: Antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase II Time: 12 monthsDescription: Maximal PSA decline at any time during the trial and PSA decline after 12 weeks (as per PCWG2 criteria) of combination treatment.
Measure: PSA decline Time: 24 monthsDescription: Overall survival will be measured from the date of AZD5069 addition to enzalutamide to the date of death (whatever cause). Survival time of living patients will be censored on the last date of patient is known to be alive or lost to follow up.
Measure: Overall survival of patients in Phase II Time: 24 monthsDescription: rPFS will be measured from the date of AZD5069 addition to enzalutamide until: Progression of soft tissue/visceral disease by RESIST and/or, Progression of bone disease by PCWG2 bone scan criteria and/or, Death of any cause Patients withdrawn for any reason prior to radiological progression then the patient should be assessed until radiological progression has occurred. If however they have started another treatment then they will be censored at the start of the new treatment.
Measure: To estimate the radiologic progression free survival (rPFS) on the combination in Phase II Time: 24 monthsDescription: CTC fall by >30% will be expressed as the proportion of patients that have demonstrated a CTC fall of >30% after 12 weeks of combination treatment.
Measure: To assess the effects of AZD5069 and enzalutamide on the number of circulating tumour cells in Phase II Time: 24 monthsDescription: Recording the population exposure to the AZD5069 and enzalutamide combination will summarise safety. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measure: To further evaluate the safety and tolerability of the combination in patients who progress on enzalutamide in Phase II Time: 24 monthsDescription: Number of patients with a neutrophil to lymphocyte ratio (NLR) ≥ 3 (at baseline) that convert to an NLR < 3 (blood nadir) with AZD5069 and enzalutamide in combination.
Measure: To further characterise the PD profile of AZD5069 and enzalutamide when administered in combination in Phase II Time: 24 monthsDescription: Plasma concentration of enzalutamide and AZD5069 in whole blood
Measure: To characterise the pharmacokinetic (PK) profile of enzalutamide and AZD5069 when administered in combination in Phase I Time: 24 monthsDescription: Number of patients with a neutrophil to lymphocyte ratio (NLR) ≥ 3 (at baseline) that convert to an NLR < 3 (blood nadir) with AZD5069 and enzalutamide in combination.
Measure: To characterise the pharmacodynamic (PD) profile of AZD5069 and enzalutamide when administered in combination in Phase I Time: 24 monthsDescription: Antitumour activity will be defined by response rate on the basis of the following outcomes; if any of these occur, patients will be considered to have responded: PSA decline ≥ 50% criteria confirmed 4 weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell count (CTC) of ≥ 5/7.5ml blood at baseline, conversion of CTC <5/7.5ml blood nadir.
Measure: To estimate the antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase I. Time: 24 monthsDescription: Number of patients patients whose circulating myeloid derived suppressor cells (MDSCs) and intratumoral MDSCs reduce by 50% with AZD5069 and enzalutamide in combination.
Measure: To further characterise the PD profile of AZD5069 and enzalutamide when administered in combination in Phase II Time: 24 monthsDescription: Number of patients whose circulating myeloid derived suppressor cells (MDSCs) and intratumoral MDSCs reduce by 50% with AZD5069 and enzalutamide in combination.
Measure: To characterise the pharmacodynamic (PD) profile of AZD5069 and enzalutamide when administered in combination in Phase I Time: 24 monthsDescription: For disease progression (see section 3.6) the PCWG2 criteria and RECIST (v1.1) criteria will be used. Treatment failure will be defined as: Progression of soft tissue/visceral disease by RECIST (v1.1) and/or, Progression of bone disease by PCWG2 bone scan criteria and/or Progression of PSA by PCWG2 PSA criteria.
Measure: To estimate the antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase I. Time: 24 monthsThis phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.
Description: Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen [PSA] response of > 50%). Will be conducted using the Cochran-Mantel-Haenszel test, with one-sided p-value of =< 0.05 considered significant.
Measure: Response rate (complete response + partial response) Time: Up to 2 yearsDescription: Assessed by Prostate Cancer Working Group (PCWG)3. PFS to be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Progression-free survival (PFS) Time: From the time of randomization up to 2 yearsDescription: Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval. Comparison of time to PSA progression between arms will be conducted using the log-rank test.
Measure: Time to PSA progression Time: From the time of randomization up to 2 yearsDescription: Assessed by RECIST 1.1. rPFS will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Radiographic progression-free survival (rPFS) Time: From the time of randomization up to 2 yearsDescription: Will be summarized according to treatment arm. For toxicity reporting, all adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Type of adverse events, intensity (grading), and attribution will be provided in a listing. All adverse events resulting in discontinuation, dose modification, and/or dosing interruption, and/or treatment delay of drug will also be summarized. Laboratory test results will be classified according to the CTCAE version 5.0.
Measure: Incidence of adverse events Time: Up to 2 yearsDescription: OS will be estimated with the Kaplan Meier methodology. Comparison of OS between arms will be conducted using the log-rank test base on the intention-to-treat approach, where two treatment arms will be compared regardless of cross-over or any subsequent therapy.
Measure: Overall survival (OS) Time: From the time of randomization up to 2 yearsDescription: Gene mutation frequencies and mean +/- standard deviation of quantitative biomarkers will be summarized by arm and in overall population at baseline and/or at end of study.
Measure: Gene mutation frequencies Time: Baseline up to 2 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 monthsAn open-label, multicenter, Phase 1b/2 study to determine the composite response rate of BXCL701 administered orally and daily, combined wit PEMBRO, in patients with mCRPC enrolled in Stage 2, with either Small Cell Neuroendocrine Prostate Cancer(SCNC)(Cohort A) or adenocarcinoma phenotype (Cohort B). This study will also assess other efficacy parameters as well as the safety of the combined treatment. This study will consist of two (2) stages. Lead-in Stage, in which the safety and tolerability of the combination will be assessed and confirmed. And the Efficacy Stage, in which patients will be treated with BXCL701 combined with PEMBRO.
Description: Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria; circulating tumor cell (CTC) conversion from >5/7.5 mL to <5/7.5 mL12; and a greater than 50% prostate-specific antigen (PSA) decline from baseline.
Measure: Estimate the composite response rate of the combination of BXCL701 + PEMBRO Time: up to 36 monthsDescription: The median time frame with progression-free survival with the use of BXCL701 in combination with Pembro determined by radiographic evidence.
Measure: Estimate the median radiographic progression-free survival (rPFS) of the combination of BXCL701 and PEMBRO in Cohort A and B Time: up to 36 monthsDescription: The median time frame with progression-free survival with the use of BXCL701 in combination with Pembro
Measure: Estimate the median PSA progression-free survival (PSA PFS) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 monthsDescription: The median time frame with overall survival with the use of BXCL701 in combination with Pembro
Measure: Estimate the median overall survival (OS) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 monthsDescription: The timeframe in which the tumor reacts to BXCL701 in combination with Pembro
Measure: Estimate the median duration of response (DOR) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 monthsDescription: Determines the frequency and severity of known and unknown adverse events with the use of BXCL701 in combination with Pembro
Measure: Determine the risk profile of the use of BXCL701 in combination with PEMBRO. Time: up to 36 monthsThe primary purpose of this study is to determine the effect of multiple once daily administrations of enzalutamide on the pharmacokinetics of a single dose of digoxin (P-glycoprotein (P-gp) substrate) and rosuvastatin (breast cancer resistant protein (BCRP) substrate) in participants with prostate cancer. This study will also evaluate the safety and tolerability of multiple once daily administrations of enzalutamide alone and in combination with a single dose of digoxin (P-gp substrate) and rosuvastatin (BCRP substrate) in participants with prostate cancer, as well, assess the pharmacokinetics of enzalutamide and its active metabolite.
Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: maximum concentration (Cmax) Time: Up to Day 71Description: AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) Time: Up to Day 71Description: AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) Time: Up to Day 71Description: Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures)or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Measure: Number of participants with Adverse Events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant ECG values.
Measure: Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) Time: Up to Day 101Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: maximum concentration (Cmax) Time: Up to Day 71Description: AUCtau will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: area under the concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval (AUCtau) Time: Up to Day 71Description: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) Time: Up to Day 71The purpose of this study is to find out the side effects and safety of a combination of the anti-IL23 targeting monoclonal antibody tildrakizumab in combination with abiraterone acetate in men with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study small groups of patients will be treated with increasing doses of tildrakizumab in combination with a fixed dose of abiraterone acetate(1000mg once daily). Once Phase I has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Phase II part of the study. The Phase II part of the study will evaluate the optimized dose/schedule identified in Phase I of the study in patients with metastatic castration resistant prostate cancer.
Description: To determine a maximum tolerated dose (MTD) of tildrakizumab by establishing the dose at which the DLT rate is as close to the target DLT rate of 15% as possible, in combination with abiraterone at 1000 mg OD with prednisolone at 5 mg bid, and is deemed to be tolerable by the Safety Review Committee. This will be the RP2D for tildrakizumab.
Measure: Phase I - To describe the safety and tolerability of abiraterone acetate and tildrakizumab when given in combination. To establish a RP2D for tildrakizumab, in combination with abiraterone. Time: 12 monthsDescription: Antitumour activity will be defined by response rate on the basis of the following outcomes. If any of the following occur, patients will be considered to have responded: PSA decline ≥ 50% criteria confirmed 4-weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell (CTC) count of ≥ 5/7.5ml blood at baseline, conversion of CTC count to <5/7.5ml blood nadir.
Measure: Phase II - To determine the antitumour activity of tildrakizumab (at RP2D) in combination with abiraterone in men with mCRPC. Time: 12 monthsAlphabetical 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