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Wee1 Kinase Inhibitor
Adavosertib for Cancer
Phase 2
Waitlist Available
Led By Rahul R Aggarwal
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
Male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for 3 months after treatment stops
Cohort B: Patients with histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma (with clear cell component on pathology), who have been treated with at least one prior systemic therapy for locally advanced or metastatic disease, including either tyrosine kinase inhibitor and/or immune checkpoint inhibitor, with evidence of SETD2 mutation on CLIA-certified next generation sequencing panel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial studies a drug called adavosertib to see how well it works in treating patients with SETD2-deficient solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread and have a SETD2 mutation. They must have tried at least one therapy, be able to swallow pills, not be pregnant or breastfeeding, use contraception if fertile, and meet certain health criteria like specific blood cell counts.Check my eligibility
What is being tested?
The trial is testing Adavosertib's effectiveness on patients with SETD2-deficient advanced solid tumors. It's a phase II study where the drug aims to block enzymes needed for tumor growth.See study design
What are the potential side effects?
Potential side effects of Adavosertib may include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, and other common chemotherapy-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male willing to use condoms during the study and for 3 months after it ends.
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I have advanced kidney cancer with a specific genetic change and have had previous treatment.
Select...
I am not pregnant, not breastfeeding, and if able to bear children, I agree to use contraception during the study.
Select...
I am willing and able to follow the study's requirements.
Select...
My bilirubin levels are within the normal range, even with liver issues or Gilbert's syndrome.
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I finished any radiation treatment at least a week ago and have recovered from its immediate side effects.
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My cancer has spread, is not kidney cancer, and has a specific genetic change.
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My genetic test for SETD2 mutation will be reviewed by experts.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am mostly active and can care for myself.
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
Objective response rate
Secondary outcome measures
Clinical benefit rate
Duration of response
H3K36me3 mark
+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%
Hypomagnesemia
30%
Insomnia
30%
Alopecia
30%
Constipation
30%
Hypermagnesemia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Allergic rhinitis
20%
Hyponatremia
20%
Alanine aminotransferase increased
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%
Investigations - Other, ELEVATED LDH
10%
Lymphedema
10%
Muscle weakness upper limb
10%
Photophobia
10%
Lethargy
10%
Pulmonary edema
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
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. 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
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
Rahul R AggarwalPrincipal InvestigatorYale University Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any cancer treatments except possibly LHRH analogues for over 6 months.I am a male willing to use condoms during the study and for 3 months after it ends.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I do not have active brain cancer or symptoms from previous brain metastases.Your liver enzymes (AST and ALT) are not more than three times the normal levels, or not more than five times the normal levels if you have liver metastases.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I have advanced kidney cancer with a specific genetic change and have had previous treatment.I am not pregnant, not breastfeeding, and if able to bear children, I agree to use contraception during the study.I am willing and able to follow the study's requirements.My bilirubin levels are within the normal range, even with liver issues or Gilbert's syndrome.I cannot swallow pills and do not have a feeding tube or receive nutrition through an IV.I have been treated with a WEE1 inhibitor before.My cancer has spread, is not kidney cancer, and has a specific genetic change.My genetic test for SETD2 mutation will be reviewed by experts.I finished any radiation treatment at least a week ago and have recovered from its immediate side effects.I am not allergic to the study drug AZD1775.I am not taking any medication or herbal supplements that affect CYP3A4 enzymes.My kidney function, measured by creatinine levels or clearance, is within the required range.I am mostly active and can care for myself.You need to have at least 100,000 platelets per microliter of blood.I have not had serious heart problems in the last 6 months.I have experienced side effects worse than mild from previous treatments, excluding hair loss or loss of appetite.Your hemoglobin level is at least 9 grams per deciliter.I am not pregnant or breastfeeding.You have a disease that can be accurately measured using specific criteria.I haven't taken any cancer drugs in the last 3 weeks or within their half-life period before starting AZD1775.You have enough white blood cells called neutrophils.I finished my radiation therapy less than a week ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other research studies that have utilized Adavosertib?
"Currently, 17 trials related to Adavosertib are underway. None of which have progressed to Phase 3 yet, although a vast number of clinics and medical centres (1675) across the globe are involved in running these tests. The majority of these sites reside in Houston, Texas."
Answered by AI
Are any participants currently being accepted for this research experiment?
"According to clinicaltrials.gov records, this trial is not in the process of recruiting at present. The study was originally posted on May 10th 2018 and last updated September 1st 2022; however, there are presently 4782 other active trials enrolling participants."
Answered by AI
What is the aggregate size of the population participating in this clinical trial?
"At this time, the trial is no longer actively recruiting participants. Inception was May 10th 2018 and last edited on September 1st 2022. For those looking for other studies related to carcinoma, there are currently 4765 active trials available; moreover 17 clinical trials involving Adavosertib require participants as well."
Answered by AI
What deleterious effects can be caused by taking Adavosertib?
"Our team at Power has rated Adavosertib's safety a 2, as there is only limited clinical data supporting its security. The Phase 2 trial does not yet have evidence of the drug's efficacy."
Answered by AI
Are there plentiful Canadian facilities conducting this experiment?
"Patients are currently being recruited for this clinical trial at 16 different medical sites, such as University of Chicago Medicine-Orland Park in Orland Park, University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh, and Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore."
Answered by AI
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