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ATR Kinase Inhibitor
Adavosertib + Radiation for Esophageal Cancer
Phase 1
Waitlist Available
Led By Eric D Miller
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
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a combo of adavosertib and radiation to treat esophageal/gastroesophageal cancer with no available treatment. It may stop growth of tumor cells & radiation kills them to shrink tumors.
Who is the study for?
Adults with inoperable esophageal or gastroesophageal junction cancer, including squamous cell or adenocarcinoma, that is not eligible for definitive chemoradiation. Participants must have proper liver and kidney function, no severe heart conditions, be able to swallow capsules, and have a life expectancy over 3 months. Pregnant women are excluded.Check my eligibility
What is being tested?
The trial tests the safety and optimal dosage of Adavosertib combined with radiation therapy on patients with incurable esophageal or gastroesophageal junction cancers. The goal is to see if this combination is more effective than radiation alone in stopping tumor growth.See study design
What are the potential side effects?
Potential side effects include issues related to organ functions influenced by enzymes targeted by Adavosertib, as well as typical risks associated with radiation therapy such as skin irritation and fatigue. Specific side effect profiles will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hepatitis B is under control with treatment.
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My recent ECG shows no significant heart issues.
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I am fully active or able to carry out light work.
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I am 18 years old or older.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My esophageal cancer is confirmed and cannot be removed by surgery or treated with chemoradiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD)
Secondary outcome measures
Biomarkers
Ogilvie dysphagia scores
Overall survival
+2 moreSide effects data
From 2023 Phase 1 & 2 trial • 76 Patients • NCT0209513280%
Lymphocyte count decreased
80%
Fatigue
80%
Hypoalbuminemia
80%
White blood cell decreased
80%
Vomiting
70%
Anemia
70%
Diarrhea
70%
Abdominal pain
70%
Nausea
60%
Anorexia
50%
Sinus tachycardia
50%
Cough
50%
Fever
50%
Pleural effusion
40%
Anxiety
40%
Neutrophil count decreased
40%
Aspartate aminotransferase increased
40%
Dyspnea
40%
Headache
40%
Platelet count decreased
30%
Insomnia
30%
Hypomagnesemia
30%
Alopecia
30%
Constipation
30%
Hypermagnesemia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Alanine aminotransferase increased
20%
Allergic rhinitis
20%
Hyponatremia
20%
Hematuria
20%
Wound infection
20%
Atelectasis
20%
Gait disturbance
20%
Hyperkalemia
20%
Hypophosphatemia
20%
Hypokalemia
20%
Myalgia
20%
Nasal congestion
20%
Osteoporosis
20%
Productive cough
20%
Dry mouth
20%
Hypotension
20%
Peripheral sensory neuropathy
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Muscle weakness upper limb
10%
Investigations - Other, ELEVATED LDH
10%
Lymphedema
10%
Photophobia
10%
Lethargy
10%
Pulmonary edema
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Tumor pain
10%
Alkalosis
10%
Bruising
10%
Eye disorders - Other, Visual disturbance
10%
Localized edema
10%
Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY
10%
Sinus bradycardia
10%
Generalized muscle weakness
10%
Muscle weakness lower limb
10%
Urine output decreased
10%
Chest wall pain
10%
Malaise
10%
Skin ulceration
10%
Hypothyroidism
10%
Acute kidney injury
10%
Hyperglycemia
10%
Hypoxia
10%
Non-cardiac chest pain
10%
Back pain
10%
Blood bilirubin increased
10%
Blurred vision
10%
Chills
10%
Dyspepsia
10%
Dysphagia
10%
Fecal incontinence
10%
Gastritis
10%
Hyperhidrosis
10%
Hypernatremia
10%
Hypertriglyceridemia
10%
Infections and infestations - Other, C. DIFF INFECTION
10%
Infections and infestations - Other, E COLI
10%
Infections and infestations - Other, E. COLI
10%
Investigations - Other, BUN increased
10%
Investigations - Other, elevated LDH
10%
Lipase increased
10%
Metabolism and nutrition disorders - Other, CACHEXIA
10%
Mucositis oral
10%
Oculomotor nerve disorder
10%
Paresthesia
10%
Proteinuria
10%
Respiratory, thoracic and mediastinal disorders - Other,
10%
Respiratory, thoracic and mediastinal disorders - Other, TACHYPNEA
10%
Scoliosis
10%
Skin hypopigmentation
10%
Surgical and medical procedures - Other, G-tube placement
10%
Tinnitus
10%
Urinary retention
10%
Skin and subcutaneous tissue disorders - Other, TUMOR BLEEDING
10%
Urinary tract obstruction
10%
Alkaline phosphatase increased
10%
Bone pain
10%
Creatinine increased
10%
Dysgeusia
10%
Electrocardiogram QT corrected interval prolonged
10%
Investigations - Other, VIT D DEFICIENCY
10%
Hearing impaired
10%
Investigations - Other, bicarbonate serum low
10%
Neck pain
10%
Sore throat
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part D, Rhabdomyosarcoma
Part A, Dose Level 1
Part A, Dose Level 2
Part A, Dose Level 3
Part A, Dose Level 4
Part A, Dose Level 5
Part A, PK Expansion
Part B, Neuroblastoma
Part C, Medulloblastoma/CNS PNET
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, adavosertib)Experimental Treatment2 Interventions
Patients undergo radiation therapy QD 5 days per week for 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive adavosertib PO QD for 2-5 days (depending on dose level) during weeks 1 and 3 of radiation therapy in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Adavosertib
2015
Completed Phase 2
~570
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,331 Total Patients Enrolled
Eric D MillerPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have long QT syndrome, a history of Torsades de pointes, recent heart attack, or ventricular arrhythmias.I've had radiation therapy in my chest or belly area that might overlap with new treatment areas.My recent ECG shows no significant heart issues.I have another cancer type, but it won't affect this trial's treatment.My hepatitis B is under control with treatment.I agree to use birth control during and after the study, and I am not pregnant.I am not pregnant or breastfeeding.My doctor does not believe I need immediate treatment for my brain metastases.I have recovered from side effects of previous cancer treatments, except for hair loss.My brain scans show no worsening after treatment for brain metastases.My kidney function is within the safe range for the trial.I can swallow whole capsules.I am fully active or able to carry out light work.I am 18 years old or older.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not taking any strong CYP3A4 inhibitors or inducers.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My esophageal cancer is confirmed and cannot be removed by surgery or treated with chemoradiation.I do not have any unmanaged ongoing illnesses.I can understand and am willing to sign the consent form. If I'm unable, someone can consent for me.I haven't had chemotherapy or radiotherapy in the last 3 weeks.My current medications won't interfere with the trial drug, as confirmed by the principal investigator.You are expected to live for at least 3 more months.You are currently taking part in another experimental treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy, adavosertib)
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.
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