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ATR Kinase Inhibitor
Berzosertib for Head and Neck Cancers
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and grade of toxicity
Incidence of dose limiting toxicities
Recommended phase 2 dose
Secondary outcome measures
Metabolic response rate by fluorodeoxyglucose-positron emission tomography (PET)
Overall response rate defined as complete response (CR) + partial response (PR)
Pharmacokinetic characteristics of berzosertib
Other outcome measures
Expression of tissue-based biomarkers as markers of deoxyribonucleic acid damage and predictors of clinical outcome
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (berzosertib, cisplatin, radiation therapy)Experimental Treatment4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berzosertib
2021
Completed Phase 2
~80
Cisplatin
2013
Completed Phase 3
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,924,574 Total Patients Enrolled
Taofeek K OwonikokoPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot be taking any other experimental drugs or treatments.You have a medical condition that is not well controlled or managed.You cannot participate if you have nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), or salivary gland carcinomas.You have a mental health condition or social circumstances that might make it difficult for you to follow the study instructions.You have neck cancer where the original source is unknown, regardless of HPV/p16 status.You are currently taking a medication called tacrolimus or any other medication that can weaken your immune system and may interfere with the effectiveness of cisplatin.You currently have a serious infection that requires treatment with antibiotics given through a vein.You are expected to live for more than 3 months.You have had allergic reactions to drugs that are similar to M6620 (VX-970, berzosertib) or cisplatin.You have had a heart attack in the past 6 months.You have unstable chest pain or irregular heart rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (berzosertib, cisplatin, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
From how many individual sites is this trial being administered?
"This study is enrolling at 10 sites, including University of Kentucky/Markey Cancer Center in Lexington, Smilow Cancer Hospital Care Center-Trumbull in Trumbull, and University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh."
Answered by AI
What is the Berzosertib success rate in getting FDA approval?
"Berzosertib's safety is unproven because it is only in Phase 1 of clinical trials."
Answered by AI
What conditions does Berzosertib normally help alleviate?
"Berzosertib is approved to treat advanced ovarian cancer as well as other serious illnesses like refractory to standard therapies, neoplasm metastasis, and advance directives."
Answered by AI
What other drugs has Berzosertib been studied in combination with?
"Berzosertib was first studied at City of Hope Comprehensive Cancer Center in 1997. Out of the 1603 completed clinical trials, 786 are active and ongoing. Many of these active trials are taking place in Lexington, Kentucky."
Answered by AI
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