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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
  • Embryonal Tumor With Multilayered Rosettes
  • Medulloblastoma
  • Neuroblastoma
  • Rhabdomyosarcoma
  • Solid Tumors
  • Rhabdoid Tumor
  • Ganglioneuroblastoma
  • Pinealoblastoma
  • Brain Tumor
  • Brain Stem Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more
Secondary 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 • 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%
Neutrophil count decreased
40%
Anxiety
40%
Aspartate aminotransferase increased
40%
Dyspnea
40%
Headache
40%
Platelet count decreased
30%
Hypermagnesemia
30%
Insomnia
30%
Constipation
30%
Alopecia
30%
Hypomagnesemia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Hematuria
20%
Allergic rhinitis
20%
Hyponatremia
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%
Localized edema
10%
Pulmonary edema
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Investigations - Other, ELEVATED LDH
10%
Tumor pain
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Muscle weakness upper limb
10%
Bruising
10%
Lethargy
10%
Lymphedema
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
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%
Eye disorders - Other, Visual disturbance
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%
Photophobia
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
13,609 Previous Clinical Trials
40,915,570 Total Patients Enrolled
Kristina A ColePrincipal InvestigatorCOG Phase I Consortium

Media Library

Adavosertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02095132 — Phase 1 & 2
Central Nervous System Tumor Research Study Groups: Treatment (irinotecan hydrochloride, adavosertib)
Central Nervous System Tumor Clinical Trial 2023: Adavosertib Highlights & Side Effects. Trial Name: NCT02095132 — Phase 1 & 2
Adavosertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02095132 — Phase 1 & 2

Frequently Asked Questions

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

Would I be able to help out with this research project?

"This rhabdomyosarcoma clinical trial has an age limit of 21 years old and is looking for around 76 participants."

Answered by AI

Are there any other similar research projects to Adavosertib?

"As of today, there are 291 ongoing clinical trials for Adavosertib with 53 of them in Phase 3. Most of these trials take place Woolloongabba, Queensland; however, research is being conducted at 10332 different locations worldwide."

Answered by AI

How many hospitals are a part of this clinical trial?

"There are a total of 24 hospitals that are participating in this clinical trial, which include the Children's Hospital of Wisconsin in Milwaukee, the Children's Hospital of Alabama in Birmingham, and the Children's Hospital of Philadelphia in Philadelphia."

Answered by AI

How many patients are participating in this clinical trial?

"This study is not enrolling new patients at this moment. It was originally posted on March 27th, 2014 and was last edited on October 7th, 2022. If you are interested in other studies, there are 3679 trials for rhabdomyosarcoma and 291 for Adavosertib that are currently recruiting participants."

Answered by AI

What are we hoping to achieve by conducting this research?

"The purpose of this study is to investigate the pharmacokinetic parameters of adavosertib in terms of systemic exposure and maximum plasma concentration. This will be done by measuring patients prior to receiving irinotecan, before and after they receive a dose of adavosertib, on day 2. Secondary outcomes include changes in gamma H2AX levels, percentage of neuroblastoma patients with MYCN amplification, and predictive biomarkers for adavosertib sensitivity."

Answered by AI

What medical conditions does Adavosertib help to treat?

"This medication is used to target cancerous growths in the pancreas, but it can also be effective against metastatic neoplasms, stomach cancers, and rhabdomyosarcoma."

Answered by AI

Are young adults eligible for this clinical trial?

"Based on the inclusion criteria for this study, it appears that applicants must be between 1 year old and 21 years old. Out of the 682 similar studies, this is one of 3500 trials involving people over the age of 65."

Answered by AI

Are people currently being enrolled in this trial?

"According to the latest information available on clinicaltrials.gov, this study is not currently recruiting patients for participation. Although the trial was last updated on October 7th, 2022, it is not presently looking for candidates. There are 3,970 other trials that are actively searching for patients right now."

Answered by AI
~7 spots leftby Mar 2025