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Kinase Inhibitor

Genetic Testing-Directed Therapy for Pediatric Cancer

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
Must not have
Patients who have an uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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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.
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My kidney function, measured by creatinine clearance or GFR, is normal or above.
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I am between 12 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any infections that are currently uncontrolled.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Incidence of research biopsy related target toxicity
Percentage of patients with grade 3 or 4 adverse events
Pharmacokinetic (PK) parameters
+1 more
Other study objectives
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
33%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2011
Completed Phase 2
~2200
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Bone Scan
2015
Completed Phase 2
~50
Radionuclide Imaging
2004
Completed Phase 2
~50
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Selpercatinib
2021
Completed Phase 1
~600
Computed Tomography
2017
Completed Phase 2
~2740
Selumetinib Sulfate
2017
Completed Phase 2
~80
Tazemetostat
2016
Completed Phase 2
~1050
Tipifarnib
2019
Completed Phase 3
~1000
Ulixertinib
2020
Completed Phase 1
~20
Vemurafenib
2015
Completed Phase 3
~3550
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Erdafitinib
2017
Completed Phase 2
~150
Ensartinib
2017
Completed Phase 2
~50
Olaparib
2007
Completed Phase 4
~2190
Palbociclib
2017
Completed Phase 3
~3880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,898 Previous Clinical Trials
41,010,403 Total Patients Enrolled
54 Trials studying Wilms Tumor
19,004 Patients Enrolled for Wilms Tumor
Donald W ParsonsPrincipal InvestigatorChildren's Oncology Group

Media Library

Erdafitinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03155620 — Phase 2
Wilms Tumor 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)
Wilms Tumor 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
~670 spots leftby Sep 2027
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