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Anti-metabolites

Berzosertib + Gemcitabine for Ovarian Cancer

Phase 2

Waitlist Available

Led By Panagiotis A Konstantinopoulos

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

No known hypersensitivity or contraindication to the components of study treatment (M6620 [VX-970], gemcitabine)

Creatinine =< upper limit of institutional normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (within 2 weeks prior to initiation of study treatment)

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970) or gemcitabine

Patients with primary platinum refractory disease, defined as progression while first line platinum based chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, M6620, to see if it is more effective than standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?

This trial is for patients with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatment and has recurred. Participants must have measurable disease, resolved prior therapy side effects (except hair loss), good physical health, and adequate organ function. They can't join if they've had certain recent treatments, brain metastases, uncontrolled illnesses, are pregnant/breastfeeding or HIV-positive on antiretrovirals.

What is being tested?

The study compares the effectiveness of adding ATR kinase inhibitor M6620 (Berzosertib) to gemcitabine hydrochloride versus using gemcitabine alone in recurrent cancers. M6620 potentially enhances cell growth inhibition by blocking a key enzyme and may improve gemcitabine's efficacy.

What are the potential side effects?

Potential side effects include reactions related to cell growth inhibition which could affect various organs and systems in the body. Specific side effects aren't listed but generally might involve fatigue, nausea, blood count changes or increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am not allergic to the study drugs M6620 or gemcitabine.

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My kidney function is normal or nearly normal.

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All my side effects from previous treatments, except hair loss, are mild or gone.

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My cancer is high grade and resistant to platinum treatment.

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

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I am fully active or able to carry out light work.

Exclusion Criteria

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

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I am allergic to medications similar to M6620 or gemcitabine.

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My cancer got worse during my first platinum-based chemotherapy.

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I have undergone radiotherapy in the last 4 weeks.

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

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I am not pregnant or breastfeeding.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate (CBR)

Duration of Response

Number of Participants With Serious Adverse Events (SAEs)

+5 more

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 II (gemcitabine, ATR kinase inhibitor M6620)Experimental Treatment3 Interventions

Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 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 I (gemcitabine hydrochloride)Active Control2 Interventions

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420