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ATR Kinase Inhibitor

A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
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 from screening to safety follow-up (30 days after last dose)
Awards & highlights
No Placebo-Only Group

Summary

This trial continues the use of adavosertib for patients with advanced solid tumors. The goal is to ensure the medication remains safe and effective for these patients. Adavosertib works by preventing cancer cells from multiplying.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to safety follow-up (30 days after last dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to safety follow-up (30 days after last dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with serious and non-serious adverse events

Side effects data

From 2023 Phase 1 & 2 trial • 76 Patients • NCT02095132
80%
Lymphocyte count decreased
80%
Fatigue
80%
Hypoalbuminemia
80%
White blood cell decreased
80%
Vomiting
70%
Diarrhea
70%
Anemia
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%
Alopecia
30%
Hypermagnesemia
30%
Hypomagnesemia
30%
Constipation
30%
Insomnia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Hyponatremia
20%
Hematuria
20%
Allergic rhinitis
20%
Alanine aminotransferase increased
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%
Alkalosis
10%
Lethargy
10%
Muscle weakness upper limb
10%
Bruising
10%
Localized edema
10%
Lymphedema
10%
Eye disorders - Other, Visual disturbance
10%
Tumor pain
10%
Pulmonary edema
10%
Investigations - Other, ELEVATED LDH
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
10%
Photophobia
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

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: Patients with advanced solid tumoursExperimental Treatment1 Intervention
Patients with advanced solid tumours will receive Adavosertib once daily for 5 days followed by 2 days off for 2 weeks out of a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adavosertib
2015
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,590 Total Patients Enrolled
ParexelIndustry Sponsor
313 Previous Clinical Trials
96,681 Total Patients Enrolled
~1 spots leftby Dec 2025
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