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ATR Kinase Inhibitor
Adavosertib Before Surgery for Ovarian Cancer
Phase < 1
Waitlist Available
Led By Shannon N Westin
Research Sponsored by M.D. Anderson Cancer Center
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 baseline up to 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how a drug affects the DNA of patients with advanced ovarian cancer to see if it can help doctors plan more effective treatment.
Who is the study for?
This trial is for women with advanced high-grade ovarian, fallopian tube, or primary peritoneal cancer who haven't had prior treatment for these conditions. Participants must be able to swallow pills, use effective contraception if of childbearing potential, and have no gastrointestinal issues affecting medication absorption. They should understand the study and consent to it, meet certain health criteria including an ECOG status of 0 or 1, and be scheduled for surgery within a specific timeframe.
What is being tested?
The trial is testing how adavosertib affects tumor DNA in patients undergoing surgery for aggressive cancers of the ovary, fallopian tube, or peritoneum. It's an early phase I pilot study aimed at understanding DNA characteristics that influence treatment response to help plan better therapies.
What are the potential side effects?
While not explicitly listed in the provided information, side effects from adavosertib may include nausea, fatigue, blood count changes (like low white blood cells), diarrhea and other gastrointestinal symptoms based on similar medications' profiles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in level of deoxyribonucleic acid (DNA) copy number in p53-related pathways
Change in level of protein expression in p53-related pathways
Change in level of ribonucleic acid (RNA) expression in p53-related pathways
Side 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%
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%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Muscle weakness upper limb
10%
Alkalosis
10%
Tumor pain
10%
Lethargy
10%
Bruising
10%
Localized edema
10%
Lymphedema
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
10%
Eye disorders - Other, Visual disturbance
10%
Pulmonary edema
10%
Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY
10%
Investigations - Other, ELEVATED LDH
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: Treatment (adavosertib)Experimental Treatment2 Interventions
Patients receive adavosertib PO QD on days 1-5. Patients then undergo standard of care laparoscopy. Patients may also receive adavosertib PO QD on days 8-12, 15-19, and 22-26 for up to 28 days based on surgery schedule.
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?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,309 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,049 Total Patients Enrolled
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other cancers that are currently being treated, unless certain exceptions apply.You have major symptoms from the suspected illness.You have not received treatment before for a specific type of ovarian, fallopian tube, or peritoneal cancer.Your blood and other body chemical levels need to be within certain normal ranges.You are able to perform daily activities without any limitations or with only slight restrictions.Be careful if you are taking certain medications or herbal supplements that might interact with the study drug.You need to have a negative pregnancy test within 3 days before starting the study.You cannot take certain medications because they might interfere with the study drug.You have advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma based on certain clinical signs.You have received treatment for ovarian, fallopian tube, or primary peritoneal cancer before.You have a brain disease that is not stable or being treated.You need to meet certain heart and heart rhythm requirements.
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.