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    HP:0012125: Prostate cancer

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (17)


    Name (Synonyms) Correlation
    drug3904 Talabostat Mesylate plus Pembrolizumab Wiki 0.45
    drug540 Berzosertib Wiki 0.45
    drug3318 Remain COVID Free SSI Wiki 0.45
    Name (Synonyms) Correlation
    drug2098 Laboratory Biomarker Analysis Wiki 0.45
    drug2239 MGC018 Wiki 0.45
    drug4476 enzalutamide Placebo Wiki 0.45
    drug183 Abiraterone Acetate Wiki 0.45
    drug4713 rosuvastatin Wiki 0.45
    drug3625 Simulation Intervention Wiki 0.45
    drug4475 enzalutamide Wiki 0.45
    drug1249 Docetaxel Wiki 0.45
    drug4459 digoxin Wiki 0.45
    drug1023 Contain COVID Anxiety SSI Wiki 0.45
    drug2238 MGA012 Wiki 0.45
    drug4017 Tildrakizumab Wiki 0.32
    drug848 Carboplatin Wiki 0.32
    drug1030 Control Wiki 0.12

    Correlated MeSH Terms (6)


    Name (Synonyms) Correlation
    D011471 Prostatic Neoplasms NIH 1.00
    D018288 Carcinoma, Small Cell NIH 0.45
    D055752 Small Cell Lung Carcinoma NIH 0.32
    Name (Synonyms) Correlation
    D018358 Neuroendocrine Tumors NIH 0.26
    D064726 Triple Negative Breast Neoplasms NIH 0.20
    D002277 Carcinoma NIH 0.16

    Correlated HPO Terms (3)


    Name (Synonyms) Correlation
    HP:0030357 Small cell lung carcinoma HPO 0.32
    HP:0100634 Neuroendocrine neoplasm HPO 0.26
    HP:0030731 Carcinoma HPO 0.16

    Clinical Trials

    Navigate: Correlations   HPO

    There are 5 clinical trials


    1 A Phase 2 Study of M6620 in Combination With Carboplatin Compared With Docetaxel in Combination With Carboplatin in Metastatic Castration-Resistant Prostate Cancer

    This 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.

    NCT03517969
    Conditions
    1. Castration-Resistant Prostate Carcinoma
    2. Metastatic Prostate Carcinoma
    3. Stage IV Prostate Cancer AJCC v8
    Interventions
    1. Drug: Berzosertib
    2. Drug: Carboplatin
    3. Drug: Docetaxel
    4. Other: Laboratory Biomarker Analysis
    MeSH:Carcinoma Prostatic Neoplasms
    HPO:Carcinoma Prostate cancer Prostate neoplasm

    Primary Outcomes

    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 years

    Secondary Outcomes

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Other Outcomes

    Description: 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 years

    Description: 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 years
    2 A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors

    The 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.

    NCT03729596
    Conditions
    1. Advanced Solid Tumor, Adult
    2. Metastatic Castrate Resistant Prostate Cancer
    3. Non Small Cell Lung Cancer
    4. Triple Negative Breast Cancer
    Interventions
    1. Biological: MGC018
    2. Biological: MGA012
    MeSH:Prostatic Neoplasms Triple Negative Breast Neoplasms
    HPO:Prostate cancer Prostate neoplasm

    Primary Outcomes

    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 dose

    Description: Maximum tolerated or maximum administered dose of MGC018 and MGC018 + MGA012

    Measure: Maximum Tolerated Dose

    Time: up to 42 days from first dose

    Secondary Outcomes

    Description: 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 months

    Description: Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA)

    Measure: PSA response rate

    Time: 24 months

    Description: 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 months

    Description: 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 months

    Description: Area under the plasma concentration versus time curve of MGC018 and MGC018+MGA012

    Measure: Area under the curve

    Time: 24 months

    Description: Maximum Plasma Concentration of MGC018 and MGC018+MGA012

    Measure: Cmax

    Time: 24 months

    Description: Time to reach maximum (peak) plasma concentration of MGC018 and MGC018+MGA012

    Measure: Tmax

    Time: 24 months

    Description: Trough plasma concentration of MGC018 and MGC018+MGA012

    Measure: Ctrough

    Time: 24 months

    Description: Total body clearance of the drug from plasma of MGC018 and MGC018+MGA012

    Measure: CL

    Time: 24 months

    Description: Apparent volume of distribution at steady state of MGC018 and MGC018+MGA012

    Measure: Vss

    Time: 24 months

    Description: Terminal half life of MGC018 and MGC018+MGA012

    Measure: t1/2

    Time: 24 months

    Description: Percent of patients with anti-drug antibodies against MGC018 and MGA012

    Measure: Immunogenicity

    Time: 24 months
    3 Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases, Administered in Combination With the Anti-Programmed Cell Death 1 Monoclonal Antibody Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype

    An 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.

    NCT03910660
    Conditions
    1. Prostate Cancer
    2. Neuroendocrine Tumors
    3. Small Cell Carcinoma
    Interventions
    1. Drug: Talabostat Mesylate plus Pembrolizumab
    MeSH:Prostatic Neoplasms Neuroendocrine Tumors Carcinoma, Small Cell Small Cell Lung Carcinoma
    HPO:Neuroendocrine neoplasm Prostate cancer Prostate neoplasm Small cell lung carcinoma

    Primary Outcomes

    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 months

    Secondary Outcomes

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months
    4 A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer

    The 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.

    NCT04094519
    Conditions
    1. Prostate Cancer
    Interventions
    1. Drug: enzalutamide
    2. Drug: enzalutamide Placebo
    3. Drug: digoxin
    4. Drug: rosuvastatin
    MeSH:Prostatic Neoplasms
    HPO:Prostate cancer Prostate neoplasm

    Primary Outcomes

    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 71

    Description: 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 71

    Description: 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 71

    Secondary Outcomes

    Description: 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 101

    Description: 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 101

    Description: 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 101

    Description: 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 101

    Description: 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 71

    Description: 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 71

    Description: 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 71
    5 ACTION: Phase I/II Trial of Abiraterone Acetate in Combination With Tildrakizumab (Anti-IL23 Targeting Monoclonal Antibody) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    The 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.

    NCT04458311
    Conditions
    1. Metastatic Castration Resistant Prostate Cancer
    Interventions
    1. Drug: Abiraterone Acetate
    2. Drug: Tildrakizumab
    MeSH:Prostatic Neoplasms
    HPO:Prostate cancer Prostate neoplasm

    Primary Outcomes

    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 months

    Description: 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 months

    HPO Nodes


    Reports

    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.

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