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Enzyme Inhibitor

Berzosertib + Carboplatin +/- Docetaxel for Prostate Cancer

Q: With what type of ailment is Berzosertib most often used?

<p>Berzosertib is not only useful for treating <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, but also common secondary conditions like head and <a href="https://www.withpower.com/clinical-trials/soft-tissue-sarcoma">soft tissue sarcoma</a> (STS), as well as non-Hodgkin <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>.</p>

Phase 2

Waitlist Available

Led By Atish D Choudhury

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically or cytologically confirmed prostate cancer with progressive disease

Patients must have metastatic disease by bone scan or other nodal or visceral lesions on CT or MRI and a castrate level of testosterone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying a two-drug combination (berzosertib and carboplatin) with or without docetaxel to see if it is more effective than carboplatin and docetaxel alone in treating patients with castration-resistant prostate cancer that has spread to other parts of the body.

Who is the study for?

This trial is for men with metastatic castration-resistant prostate cancer that has progressed despite previous treatments. Participants must have a low testosterone level, adequate organ function, and no severe side effects from past cancer therapies. They should not have brain metastases or active infections and must not be on certain drugs that could interact with the study medication.Check my eligibility

What is being tested?

The trial is testing the effectiveness of berzosertib (M6620) combined with carboplatin, with or without docetaxel, in treating advanced prostate cancer. Berzosertib blocks enzymes needed for cell growth while carboplatin and docetaxel are chemotherapy drugs aiming to kill or stop the spread of tumor cells.See study design

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as fatigue, nausea, hair loss, blood disorders like anemia or clotting problems, nerve damage which might cause numbness or tingling sensations, and increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed and getting worse.

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My cancer has spread, shown by scans, and I have low testosterone levels.

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My kidneys are functioning well enough (creatinine clearance rate is good).

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I have had at least 2 treatments for advanced prostate cancer that did not respond to hormone therapy.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate (complete response + partial response)

Secondary outcome measures

Incidence of adverse events

Progression-free survival (PFS)

Radiographic progression-free survival (rPFS)

+1 more

Other outcome measures

Gene mutation frequencies

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (carboplatin, berzosertib)Experimental Treatment3 Interventions

Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (docetaxel, carboplatin)Active Control3 Interventions

Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Berzosertib

2021

Completed Phase 2

~80

Carboplatin

2014

Completed Phase 3

~6670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,513 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Atish D ChoudhuryPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Media Library

Berzosertib (M6620) (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03517969 — Phase 2

Prostate Cancer Research Study Groups: Arm B (carboplatin, berzosertib), Arm A (docetaxel, carboplatin)

Prostate Cancer Clinical Trial 2023: Berzosertib (M6620) Highlights & Side Effects. Trial Name: NCT03517969 — Phase 2

Berzosertib (M6620) (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517969 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the dangers of Berzosertib for patients?

"While Phase 2 trials are not as robust as Phase 3 trials, there is still some data supporting the safety of Berzosertib."

Answered by AI

Where can patients find this trial being offered?

"There are 23 locations where this clinical trial is currently accepting patients. A few of these sites include University of California Davis Comprehensive Cancer Center in Sacramento, California, Smilow Cancer Hospital-Orange Care Center in Orange, Massachusetts, and Smilow Cancer Hospital-Derby Care Center in Derby, Ohio."

Answered by AI

How many people are currently signed up to participate in this research?

"This study is not recruiting patients at this time. The trial was first posted on 10/12/2018 and was most recently edited on 7/16/2022. If you are exploring other studies, there are currently 3772 studies actively looking for patients with prostate cancer and 1013 studies for Berzosertib actively recruiting participants."

Answered by AI

With what type of ailment is Berzosertib most often used?

"Berzosertib is not only useful for treating melanoma, but also common secondary conditions like head and soft tissue sarcoma (STS), as well as non-Hodgkin lymphoma."

Answered by AI

Are volunteers still required for this experiment?

"As of July 16th, 2022, this study is no longer recruiting patients. The trial was initially posted on October 12th, 2018 and had a total duration of 3 years and 9 months. For individuals seeking other trials, 3772 studies are currently looking for patients with prostate cancer while 1013 studies are actively enrolling patients for Berzosertib treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

2019. "M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03517969.

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