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D011471: Prostatic Neoplasms

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 (18)


Name (Synonyms) Correlation
drug3864 digoxin Wiki 0.45
drug3083 Sensitivity and Couples' Intervention Wiki 0.45
drug1929 MGC018 Wiki 0.45
Name (Synonyms) Correlation
drug460 Berzosertib Wiki 0.45
drug3478 Tildrakizumab Wiki 0.45
drug3373 Talabostat Mesylate plus Pembrolizumab Wiki 0.45
drug4094 rosuvastatin Wiki 0.45
drug3082 Sensitivity Intervention Wiki 0.45
drug3875 enzalutamide Wiki 0.45
drug851 Communication type Wiki 0.45
drug1079 Docetaxel Wiki 0.45
drug151 Abiraterone Acetate Wiki 0.45
drug1806 Laboratory Biomarker Analysis Wiki 0.45
drug930 Couples' Intervention Wiki 0.45
drug1928 MGA012 Wiki 0.45
drug3876 enzalutamide Placebo Wiki 0.45
drug729 Carboplatin Wiki 0.32
drug881 Control Wiki 0.14

Correlated MeSH Terms (5)


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

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0012125 Prostate cancer HPO 0.89
HP:0030357 Small cell lung carcinoma HPO 0.45
HP:0100634 Neuroendocrine neoplasm HPO 0.26
Name (Synonyms) Correlation
HP:0030731 Carcinoma HPO 0.16
HP:0002664 Neoplasm HPO 0.09

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


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Data processed on September 26, 2020.

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