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Protein Kinase Inhibitor

Adavosertib for Cancer with BRCA Mutations

Phase 2
Waitlist Available
Led By Shivaani Kummar
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
Patients must have mutation in the BRCA1 or BRCA2 gene in the tumor, or another aberration, as determined via the MATCH Master Protocol. Patients with tumor carrying mutations defined as variants of uncertain significance will not qualify
Patients with ovarian cancer or HER2 negative, metastatic breast cancer must have received a PARP inhibitor as part of or as one of their prior lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 3 cycles until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing a drug, AZD1775, to see if it can shrink or stop the growth of cancer cells that have a BRCA mutation.

Who is the study for?
This trial is for cancer patients with a specific genetic change called BRCA mutation. They must have had prior eligibility in the Master MATCH Protocol, normal heart rhythm and function on an ECG, and acceptable blood hemoglobin levels. Those with ovarian or metastatic breast cancer should have tried PARP inhibitors before.Check my eligibility
What is being tested?
Researchers are testing AZD1775 to see if it can shrink or stop the growth of cancers that have BRCA mutations. AZD1775 targets a protein called WEE1 which might be essential for these cancer cells' growth.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions related to targeting the WEE1 protein, which could affect cell division and potentially lead to fatigue, nausea, or other common chemotherapy-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor has a confirmed BRCA1 or BRCA2 mutation.
Select...
I have ovarian or HER2 negative breast cancer and have been treated with a PARP inhibitor.
Select...
My recent ECG showed no significant heart issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 3 cycles until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 3 cycles until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)

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%
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%
Muscle weakness upper limb
10%
Investigations - Other, ELEVATED LDH
10%
Lymphedema
10%
Pulmonary edema
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Photophobia
10%
Lethargy
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 (adavosertib)Experimental Treatment1 Intervention
Patients receive adavosertib PO QD on days 1-5 and 8-12 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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?

National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,336 Total Patients Enrolled
Shivaani KummarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Adavosertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439227 — Phase 2
Cancer Research Study Groups: Treatment (adavosertib)
Cancer Clinical Trial 2023: Adavosertib Highlights & Side Effects. Trial Name: NCT04439227 — Phase 2
Adavosertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439227 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of participation in this scientific investigation?

"This clinical trial is no longer seeking potential candidates. It was first launched on March 13th 2017 and last updated on September 14th 2022. If you are interested in alternative studies, there are presently 4670 trials actively enrolling patients with malignant neoplasms and 17 programs looking for Adavosertib volunteers."

Answered by AI

What potential risks accompany the use of Adavosertib?

"Based on Power's assessment, Adavosertib falls into the safety rating of 2 since there has yet to be any efficacy data gathered in Phase 2 trials."

Answered by AI

What prior investigations have been conducted on the use of Adavosertib?

"Currently, 17 research projects are conducting studies on Adavosertib - none of which have progressed to the Phase 3 stage. Although most trials for this drugs originate from Berkeley, California; there are 1675 other sites around the globe that are running related tests."

Answered by AI

Is participation in this experiment available to the public at present?

"As per the information on clinicaltrials.gov, this research project is not currently recruiting participants. Initially published on March 13th in 2017 and recently edited September 14th 2022, there are no open slots at this time. Nevertheless, 4687 other trials are actively enrolling patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)
2017. "Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439227.
~5 spots leftby Jun 2025
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