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Protein Kinase Inhibitor
Adavosertib for Central Nervous System Tumor
Phase 1 & 2
Waitlist Available
Led By Kristina A Cole
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of a combination of adavosertib and irinotecan hydrochloride in treating patients with solid tumors that have come back or have not responded to standard therapy.
Eligible Conditions
- Central Nervous System Tumor
- Rhabdomyosarcoma
- Embryonal Tumor With Multilayered Rosettes
- Medulloblastoma
- Neuroblastoma
- Solid Tumors
- Rhabdoid Tumor
- Ganglioneuroblastoma
- Pinealoblastoma
- Brain Tumor
- Brain Stem Glioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of Participants With Cycle 1 DLT
Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC
+3 moreSecondary outcome measures
Mean Fold Change in Gamma H2AX in Peripheral Blood Mono Nuclear Cells
Number and Percentage of Part B Neuroblastoma Participants With MYCN Amplification
Number and Percentage of Participants With Best Overall Response With Partial or Complete Response
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%
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 (irinotecan hydrochloride, adavosertib)Experimental Treatment2 Interventions
Patients receive irinotecan hydrochloride PO and adavosertib PO on days 1-5. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1775
Not yet FDA approved
Irinotecan
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,287 Total Patients Enrolled
Kristina A ColePrincipal InvestigatorCOG Phase I Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot swallow pills and feeding through a tube is not allowed.You have a solid tumor that has come back after treatment or is not responding to treatment, including tumors in the brain that started there or have spread from somewhere else.You have received an organ transplant in the past.You have rhabdomyosarcoma that has come back after treatment or is not responding to treatment.You must wait at least 42 days after completing immunotherapy like tumor vaccines.You have an infection that is not under control.You are currently taking a medication that is still being tested and not approved for public use.You are currently taking other medications to treat cancer.You have had a severe allergic reaction to irinotecan or certain types of antibiotics (cephalosporins or penicillin).If you can have children, you are not using two effective methods of birth control.You are able to swallow pills.You are pregnant or currently breastfeeding.You have neuroblastoma that has either come back after treatment or is not responding to treatment.You do not have any known treatments available that can cure or improve your condition and quality of life.You have fully recovered from any harmful effects caused by previous cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (irinotecan hydrochloride, adavosertib)
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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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