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BerzosertibWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (14)


Name (Synonyms) Correlation
drug1131 Hydroxychloroquine, Doxycycline Wiki 1.00
drug782 Docetaxel Wiki 1.00
drug1223 Interferon-Alpha2B Wiki 1.00
drug1130 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 1.00
drug1127 Hydroxychloroquine, Azithromycin Wiki 1.00
drug656 Convalescent Serum Wiki 1.00
drug1129 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 1.00
drug1319 Laboratory Biomarker Analysis Wiki 1.00
drug1128 Hydroxychloroquine, Clindamycin Wiki 1.00
drug522 Carboplatin Wiki 0.71
drug1374 Losartan Wiki 0.35
drug1484 Methylprednisolone Wiki 0.30
drug2067 Remdesivir Wiki 0.26
drug2527 Tocilizumab Wiki 0.19

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D011471 Prostatic Neoplasms NIH 0.58
D002277 Carcinoma NIH 0.45

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0012125 Prostate cancer HPO 0.58
HP:0030731 Carcinoma HPO 0.45

There is one clinical trial.

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 Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Drug: Berzosertib Drug: Carboplatin Drug: Docetaxel 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


Related HPO nodes (Using clinical trials)