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ATR Kinase Inhibitor

Berzosertib + Chemotherapy + Radiation for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Taofeek K Owonikoko

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dosage of a drug called M6620 when given with cisplatin and radiation therapy to treat patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes.

Who is the study for?

Adults with locally advanced head and neck squamous cell carcinoma, not suitable for surgery, can join this trial. They must have a life expectancy over 3 months, measurable disease, normal organ function tests, and agree to use contraception. Excluded are those with certain other health conditions or treatments that could interfere with the study.

What is being tested?

The trial is testing Berzosertib combined with usual chemotherapy (Cisplatin) and radiation therapy in patients with advanced head and neck cancer. It aims to find the best dose of Berzosertib that's effective but also safe when used alongside standard treatments.

What are the potential side effects?

Potential side effects include reactions related to DNA-damage response inhibition by Berzosertib which may affect cell growth, typical chemotherapy-related issues like nausea or hair loss from Cisplatin, and skin irritation from radiation therapy.

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

Frequency and grade of toxicity

Incidence of dose limiting toxicities

Recommended phase 2 dose

Secondary study objectives

Metabolic response rate by fluorodeoxyglucose-positron emission tomography (PET)

Overall response rate defined as complete response (CR) + partial response (PR)

Pharmacokinetic characteristics of berzosertib

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

1Treatment groups

Experimental Treatment

Group I: Treatment (berzosertib, cisplatin, radiation therapy)Experimental Treatment7 Interventions

Patients receive berzosertib IV over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, PET/CT, or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200