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Kinase Inhibitor

Genetic Testing-Directed Therapy for Pediatric Cancer

Q: Is there an age limit to be part of this experiment?

According to the study's entry requirements, participants must be no younger than 12 months old and not older than 21.

Q: Is the research team currently seeking new participants for this experiment?

Affirmative. As per the clinicaltrials.gov records, this research is actively recruiting participants since its inception on July 24th 2017 and most recently updated on November 29th 2022. A total of 2316 individuals are being sought out from 100 distinct medical sites.

Q: What are the desired outcomes of this experiment?

This research endeavour, which will be assessed over a two year period from recruitment to conclusion of treatment, hopes to identify the percentage of juvenile subjects whose malignant growths have molecular pathways that can be targeted by select anti-<a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> medications. Secondary objectives include tracking incidences related to biopsy toxicity (any grade 3 or greater side effect likely attributable to an anaesthetic or imaging procedure within 14 days of investigation), measuring pharmacokinetic parameters (systemic exposure, clearance rate and similar figures) as well as calculating progression free survival using Kaplan-Meier methodology with confidence intervals.

Q: What is the typical purpose of a Pharmacological Study?

Unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> is often handled with Pharmacological Study, and this form of treatment also has efficacy for catarrh, <a href="https://www.withpower.com/clinical-trials/psoriasis">psoriasis</a>, and musculoskeletal trauma.

Q: How widely is the research project being conducted in Canadian medical facilities?

This trial is enrolling at 100 different medical centres, such as Riley Hospital for Children in Indianapolis, Children's Hospital Los Angeles in Los Angeles, and Banner Children's at Desert in Mesa.

Q: Has Pharmacological Study been tested in any other clinical trials?

Currently, 521 clinical trials are underway searching for insight into Pharmacological Study. Of those studies, 90 are at the advanced Phase 3 level. The majority of these investigations take place in Phoenix, <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a>; however there exist 31121 different medical sites globally that carry out research on this treatment.

Q: Am I eligible to participate in this research project?

This trial has 2,316 participants aged between one year old and 21 years of age with rhabdoid tumors. Prerequisites include a Karnofsky score for patients over 16 of at least 50%, Lansky performance rating for those under 16 of no less than 50%, neural stability in the face of CNS tumours lasting 7 days prior to enrolment; paralysis excluding an individual from being ambulatory but only if they are confined to a wheelchair, molecular profiling report carried out on tissue collected after initial recurrence/progression (with diagnostic biopsies accepted only upon high-grade gliomas involving brainstem or thalamus),

Q: Has the Pharmacological Study achieved governmental authorization?

Our team at Power concluded that Pharmacological Study has a relatively moderate safety rating due to the lack of supporting efficacy data, despite having some evidence of its security. Thus, it was given a score of 2 on our scale from 1 to 3.

Q: What is the patient cohort size of this trial?

In total, this clinical trial requires 2316 participants that meet the prescribed inclusion criteria. These individuals can visit either Riley Hospital for Children in Indianapolis, <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> or Children's Hospital Los Angeles in <a href="https://www.withpower.com/clinical-trials/california">California</a> to take part.

Phase 2

Recruiting

Led By Donald W Parsons

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

Bilirubin =< 1.5 x upper limit of normal (ULN) for age

Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses, and central nervous system (CNS) tumors are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is studying how well treatment that is directed by genetic testing works in pediatric patients with solid tumors or non-Hodgkin lymphomas.

Who is the study for?

This trial is for pediatric patients aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have worsened after treatment or lack standard survival-prolonging treatments. They must have recovered from previous therapies' side effects, be able to swallow pills, and meet specific blood count and organ function criteria.Check my eligibility

What is being tested?

The Pediatric MATCH trial tests if targeted therapy based on genetic testing can effectively treat children's cancers. It involves various interventions like imaging scans and biopsies to identify mutations in tumor genes, followed by matching patients with medications targeting those mutations.See study design

What are the potential side effects?

Potential side effects depend on the specific medication given but may include fatigue, nausea, liver issues (elevated enzymes), skin reactions (rash), digestive problems (diarrhea), blood cell changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bilirubin levels are within the normal range for my age.

Select...

I have a recurring or hard-to-treat tumor, including in the brain, lymph system, or other solid tumors.

Select...

I am mostly able to care for myself and carry out daily activities.

Select...

My kidney function, measured by creatinine clearance or GFR, is normal or above.

Select...

I am between 12 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 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 (complete response/partial response)

Proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs

Secondary outcome measures

Incidence of research biopsy related target toxicity

Percentage of patients with grade 3 or 4 adverse events

Pharmacokinetic (PK) parameters

+1 more

Other outcome measures

Change in genomics in advanced pediatric cancers

Diagnostic and profiling genomics of tumor approach

Frequency of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

12Treatment groups

Experimental Treatment

Group I: Subprotocol N (activating RET mutations)Experimental Treatment11 Interventions

Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.

Group II: Subprotocol J (MAPK pathway mutations)Experimental Treatment6 Interventions

Patients with MAPK pathway mutations receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group III: Subprotocol I (Rb positive, alterations in cell cycle genes)Experimental Treatment6 Interventions

Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group IV: Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations)Experimental Treatment6 Interventions

Patients deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group V: Subprotocol G (BRAF V600 gene mutation)Experimental Treatment6 Interventions

Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group VI: Subprotocol F (ALK or ROS1 gene alteration)Experimental Treatment13 Interventions

Patients with an ALK or ROS1 gene alteration receive ensartinib PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Group VII: Subprotocol E (activating MAPK pathway gene mutation)Experimental Treatment6 Interventions

Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group VIII: Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation)Experimental Treatment6 Interventions

Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group IX: Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation)Experimental Treatment6 Interventions

Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group X: Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation)Experimental Treatment12 Interventions

Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Group XI: Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion)Experimental Treatment6 Interventions

Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate PO or via nasogastric- or gastric-tube BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Group XII: Subprotcol M (HRAS gene alterations)Experimental Treatment6 Interventions

Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Radionuclide Imaging

2004

Completed Phase 2

~50

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Selpercatinib

2021

Completed Phase 1

~600

Computed Tomography

2017

Completed Phase 2

~2720

Selumetinib Sulfate

2017

Completed Phase 2

~80

Tazemetostat

2016

Completed Phase 2

~1050

Tipifarnib

2000

Completed Phase 3

~710

Ulixertinib

2020

Completed Phase 1

~20

Vemurafenib

2015

Completed Phase 3

~3100

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Erdafitinib

2017

Completed Phase 2

~150

Ensartinib

2017

Completed Phase 2

~50

Olaparib

2007

Completed Phase 4

~2140

Palbociclib

2017

Completed Phase 3

~3760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,688 Previous Clinical Trials

40,928,110 Total Patients Enrolled

Donald W ParsonsPrincipal InvestigatorChildren's Oncology Group

Media Library

Erdafitinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03155620 — Phase 2

Histiocytic Sarcoma Research Study Groups: Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation), Subprotocol G (BRAF V600 gene mutation), Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations), Subprotocol I (Rb positive, alterations in cell cycle genes), Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion), Subprotocol F (ALK or ROS1 gene alteration), Subprotcol M (HRAS gene alterations), Subprotocol E (activating MAPK pathway gene mutation), Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation), Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation), Subprotocol J (MAPK pathway mutations), Subprotocol N (activating RET mutations)

Histiocytic Sarcoma Clinical Trial 2023: Erdafitinib Highlights & Side Effects. Trial Name: NCT03155620 — Phase 2

Erdafitinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03155620 — Phase 2

Frequently Asked Questions

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

Is there an age limit to be part of this experiment?

"According to the study's entry requirements, participants must be no younger than 12 months old and not older than 21."

Answered by AI

Is the research team currently seeking new participants for this experiment?

"Affirmative. As per the clinicaltrials.gov records, this research is actively recruiting participants since its inception on July 24th 2017 and most recently updated on November 29th 2022. A total of 2316 individuals are being sought out from 100 distinct medical sites."

Answered by AI

What are the desired outcomes of this experiment?

"This research endeavour, which will be assessed over a two year period from recruitment to conclusion of treatment, hopes to identify the percentage of juvenile subjects whose malignant growths have molecular pathways that can be targeted by select anti-cancer medications. Secondary objectives include tracking incidences related to biopsy toxicity (any grade 3 or greater side effect likely attributable to an anaesthetic or imaging procedure within 14 days of investigation), measuring pharmacokinetic parameters (systemic exposure, clearance rate and similar figures) as well as calculating progression free survival using Kaplan-Meier methodology with confidence intervals."

Answered by AI

What is the typical purpose of a Pharmacological Study?

"Unresectable melanoma is often handled with Pharmacological Study, and this form of treatment also has efficacy for catarrh, psoriasis, and musculoskeletal trauma."

Answered by AI

How widely is the research project being conducted in Canadian medical facilities?

"This trial is enrolling at 100 different medical centres, such as Riley Hospital for Children in Indianapolis, Children's Hospital Los Angeles in Los Angeles, and Banner Children's at Desert in Mesa."

Answered by AI

Has Pharmacological Study been tested in any other clinical trials?

"Currently, 521 clinical trials are underway searching for insight into Pharmacological Study. Of those studies, 90 are at the advanced Phase 3 level. The majority of these investigations take place in Phoenix, Arizona; however there exist 31121 different medical sites globally that carry out research on this treatment."

Answered by AI

Am I eligible to participate in this research project?

"This trial has 2,316 participants aged between one year old and 21 years of age with rhabdoid tumors. Prerequisites include a Karnofsky score for patients over 16 of at least 50%, Lansky performance rating for those under 16 of no less than 50%, neural stability in the face of CNS tumours lasting 7 days prior to enrolment; paralysis excluding an individual from being ambulatory but only if they are confined to a wheelchair, molecular profiling report carried out on tissue collected after initial recurrence/progression (with diagnostic biopsies accepted only upon high-grade gliomas involving brainstem or thalamus),"

Answered by AI

Has the Pharmacological Study achieved governmental authorization?

"Our team at Power concluded that Pharmacological Study has a relatively moderate safety rating due to the lack of supporting efficacy data, despite having some evidence of its security. Thus, it was given a score of 2 on our scale from 1 to 3."

Answered by AI

What is the patient cohort size of this trial?

"In total, this clinical trial requires 2316 participants that meet the prescribed inclusion criteria. These individuals can visit either Riley Hospital for Children in Indianapolis, Indiana or Children's Hospital Los Angeles in California to take part."

Answered by AI