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ATR Kinase Inhibitor

Chemotherapy + Berzosertib for Ovarian Cancer

Phase 1

Waitlist Available

Led By Andrea E Wahner Hendrickson

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Histologically confirmed high grade serous or endometrioid ovarian, peritoneal or fallopian tube malignancy that is metastatic and for which curative measures do not exist. The histology can be confirmed from tissue that was taken at the time of diagnosis. A biopsy at the time of recurrence prior to enrollment on study is not required

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients with platinum resistant disease or platinum sensitive disease that is past the first or second recurrence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of gemcitabine hydrochloride, berzosertib, and carboplatin to treat ovarian, primary peritoneal, or fallopian tube cancer that has returned and spread.

Who is the study for?

This trial is for adults with high-grade serous or endometrioid ovarian, peritoneal, or fallopian tube cancer that's metastatic and beyond cure. Participants must have measurable disease, be in their first or second platinum-sensitive recurrence (recurrence >6 months after last platinum therapy), and have adequate organ function. They can't join if they've had more than two prior platinum treatments, recent chemotherapy/radiotherapy, known brain metastases, allergies to the drugs being tested, are pregnant/breastfeeding, or have certain genetic syndromes.

What is being tested?

The trial tests how well patients respond to a combination of Carboplatin and Gemcitabine Hydrochloride with Berzosertib versus standard treatment alone. It aims to find the best dose of these drugs together while assessing side effects when treating recurrent/metastatic ovarian, primary peritoneal or fallopian tube cancer.

What are the potential side effects?

Potential side effects include reactions related to cell growth inhibition by Berzosertib such as fatigue and digestive issues; typical chemotherapy-related effects from Carboplatin and Gemcitabine like nausea, low blood counts leading to infection risk; plus any specific organ inflammation due to drug interactions.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My cancer is a specific type that has spread and cannot be cured with surgery or radiation.

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I have a tumor that can be measured with scans or exams.

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I am an adult.

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My kidney function is normal or nearly normal.

Exclusion Criteria

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My cancer did not respond to platinum-based treatment or it came back after such treatment.

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I am not pregnant or breastfeeding.

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I do not have Li Fraumeni syndrome.

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I have no allergies to M6620, carboplatin, gemcitabine, or similar drugs.

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I have been treated with gemcitabine before.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Incidence of adverse events

Maximum tolerated dose (MTD) (phase I dose escalation)

Secondary study objectives

Confirmed response rate

Duration of response

Overall survival (OS)

+1 more

Other study objectives

Changes in the frequency of marker inhibition

Correlation between deoxyribonucleic acid (DNA) damage markers and mutation data with clinical endpoints (i.e. response, PFS, OS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin, gemcitabine hydrochloride, VX-970)Experimental Treatment5 Interventions

Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Berzosertib

2021

Completed Phase 2

~90

Carboplatin

2014

Completed Phase 3

~6120