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Enzyme Inhibitor

Berzosertib + Carboplatin +/- Docetaxel for Prostate Cancer

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

Must not have

Prior treatment with platinum-containing regimen or ATR inhibitor for prostate cancer

Subjects receiving treatment with ototoxic or nephrotoxic medications that cannot be discontinued

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with platinum-based drugs or ATR inhibitors for prostate cancer.

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I am on medication that could harm my hearing or kidneys and cannot stop taking it.

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I do not have any uncontrolled illnesses.

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I have brain metastases or leptomeningeal disease.

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I am HIV-positive with a viral load or CD4 count of 300 or less.

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I am allergic to medications similar to M6620 or carboplatin.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate (complete response + partial response)

Secondary study objectives

Incidence of adverse events

Progression-free survival (PFS)

Radiographic progression-free survival (rPFS)

+1 more

Other study objectives

Gene mutation frequencies

Overall survival (OS)

Side effects data

From 2023 Phase 2 trial • 76 Patients • NCT04768296

100%

Anaemia

100%

Thrombocytopenia

67%

Alopecia

33%

Electrocardiogram QT prolonged

33%

Lipase increased

33%

Neutropenia

33%

Toothache

33%

Nausea

33%

Neuropathy peripheral

33%

Leukopenia

33%

Constipation

33%

Fatigue

33%

COVID-19

33%

Infusion related reaction

33%

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Safety run-in Part (Dose Level 1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2

Safety run-in Part (DL2) + Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120