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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
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 • NCT0476829666%
Anaemia
36%
Thrombocytopenia
32%
Neutropenia
30%
Platelet count decreased
27%
Nausea
25%
Decreased appetite
25%
Asthenia
18%
White blood cell count decreased
18%
Constipation
16%
Neutrophil count decreased
15%
Dyspnoea
15%
Diarrhoea
14%
Vomiting
14%
Fatigue
12%
Lymphocyte count decreased
11%
Hypokalaemia
11%
Pneumonia
10%
Hypoalbuminaemia
10%
Headache
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Cough
8%
Weight decreased
8%
Epistaxis
8%
Blood alkaline phosphatase increased
8%
Lipase increased
8%
Hypocalcaemia
7%
Hyponatraemia
7%
Pyrexia
7%
Insomnia
7%
Dizziness
5%
Haemoptysis
5%
Malaise
5%
Mucosal inflammation
5%
Hypomagnesaemia
5%
Gamma-glutamyltransferase increased
5%
Hyperglycaemia
5%
Febrile neutropenia
5%
COVID-19
5%
Hypertension
4%
Gastrooesophageal reflux disease
4%
Liver injury
4%
Oedema peripheral
4%
Dyspnoea exertional
4%
Alopecia
4%
COVID-19 pneumonia
4%
Tachycardia
4%
Abdominal pain
4%
Blood creatinine increased
4%
Hypophosphataemia
4%
Dysgeusia
3%
Haemoglobin decreased
3%
Productive cough
3%
Blood bilirubin increased
3%
Pleural effusion
3%
Localised oedema
3%
Night sweats
3%
Blood magnesium decreased
3%
Neuropathy peripheral
3%
Pruritus
3%
Chest discomfort
3%
Paraesthesia
3%
Pain
3%
Anxiety
3%
Sepsis
3%
Leukopenia
3%
Atrial fibrillation
3%
Abdominal pain upper
3%
Chills
3%
Upper respiratory tract infection
3%
Activated partial thromboplastin time prolonged
3%
Amylase increased
3%
Blood albumin decreased
3%
Blood lactate dehydrogenase increased
3%
Arthralgia
3%
Back pain
3%
Muscle spasms
3%
Dysphonia
3%
Hypotension
3%
Pallor
1%
Metastases to central nervous system
1%
Photosensitivity reaction
1%
Creatinine renal clearance decreased
1%
Acute kidney injury
1%
Electrolyte imbalance
1%
Hepatic pain
1%
Decubitus ulcer
1%
Memory impairment
1%
Pleuritic pain
1%
Blood sodium decreased
1%
Tremor
1%
Gout
1%
Presyncope
1%
Seizure
1%
Pneumonia bacterial
1%
Blood urea increased
1%
Hemiparesis
1%
Device malfunction
1%
Skin lesion
1%
Hypoglycaemia
1%
Lip dry
1%
Herpes zoster reactivation
1%
Cholestasis
1%
Wound infection
1%
Influenza like illness
1%
Conjunctival pallor
1%
Diplopia
1%
Haemorrhoids
1%
Generalised oedema
1%
Injection site pruritus
1%
Electrocardiogram QT prolonged
1%
Rash
1%
Blood phosphorus decreased
1%
C-reactive protein increased
1%
CD4/CD8 ratio decreased
1%
Hypochloraemia
1%
Depression
1%
Dyspnoea paroxysmal nocturnal
1%
Rash pruritic
1%
Secretion discharge
1%
Hyperthermia
1%
Choluria
1%
Swelling face
1%
Hyperbilirubinaemia
1%
Respiratory tract infection
1%
Nail disorder
1%
Haemorrhoids thrombosed
1%
Hyperkalaemia
1%
Transient aphasia
1%
Sinusitis
1%
Confusional state
1%
Pneumonia pneumococcal
1%
Eye discharge
1%
Gingival pain
1%
Sputum discoloured
1%
Oral disorder
1%
Wheezing
1%
Hypoxia
1%
Pneumothorax
1%
Lower gastrointestinal haemorrhage
1%
Pulmonary embolism
1%
Petechiae
1%
Tooth loss
1%
Spinal compression fracture
1%
Cancer pain
1%
Hemianopia homonymous
1%
Nasal congestion
1%
Myelosuppression
1%
Acute coronary syndrome
1%
Vestibular disorder
1%
Disease progression
1%
General physical health deterioration
1%
Multiple organ dysfunction syndrome
1%
Enterococcal sepsis
1%
Lung abscess
1%
Septic shock
1%
Serratia sepsis
1%
Staphylococcal sepsis
1%
Urinary tract infection
1%
Urosepsis
1%
Acute respiratory distress syndrome
1%
Respiratory failure
1%
Coagulopathy
1%
Thrombocytosis
1%
Arrhythmia
1%
Cardiac failure
1%
Sinus tachycardia
1%
Hypothyroidism
1%
Immune-mediated hypothyroidism
1%
Macular oedema
1%
Abdominal discomfort
1%
Abdominal distension
1%
Dry mouth
1%
Dyspepsia
1%
Dysphagia
1%
Flatulence
1%
Chest pain
1%
Face oedema
1%
Gait disturbance
1%
Hypersensitivity
1%
Bronchiolitis
1%
Bronchitis
1%
Candida infection
1%
Diverticulitis
1%
Gastroenteritis
1%
Compression fracture
1%
Fall
1%
Radiation oesophagitis
1%
Radiation pneumonitis
1%
Spinal fracture
1%
Aspartate aminotransferase decreased
1%
Blood cholesterol increased
1%
Blood glucose increased
1%
Blood lactic acid increased
1%
Platelet count increased
1%
Urine output decreased
1%
Malnutrition
1%
Muscular weakness
1%
Pain in extremity
1%
Tumour pain
1%
Disturbance in attention
1%
Nephrolithiasis
1%
Renal impairment
1%
Aphonia
1%
Deep vein thrombosis
1%
Orthostatic hypotension
1%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety run-in Part (DL2) + Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2
Safety run-in Part (Dose Level 1 [DL 1]): Berzosertib 105 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
~2790
Positron Emission Tomography
2011
Completed Phase 2
~2200
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Berzosertib
2021
Completed Phase 2
~90
Cisplatin
2013
Completed Phase 3
~3120
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,044 Total Patients Enrolled
Taofeek K OwonikokoPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center 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.