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Tyrosine Kinase Inhibitor

Erdafitinib for Cancer

Phase 2

Waitlist Available

Led By Alice Lee

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

Patients must not have received prior exposure to erdafitinib or another FGFR inhibitor such as (but not limited to) AZD4547, BGJ398, BAY1163877, LY2874455

Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =/< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L) (performed within 7 days prior to enrollment)

Must not have

A history of any of the following: sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, cardiac arrest, Mobitz II second degree heart block or third degree heart block; known presence of dilated, hypertrophic, or restrictive cardiomyopathy

Patients who have an uncontrolled infection are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses erdafitinib to treat patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread and come back or don't respond to treatment with FGFR mutations.

Who is the study for?

This trial is for children and young adults aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have FGFR mutations. Participants must be able to swallow tablets, have not been treated with erdafitinib before, and meet specific health criteria like normal bilirubin levels and kidney function.

What is being tested?

The study tests the effectiveness of erdafitinib in patients whose cancer has returned or is resistant to treatment. It aims to see if this drug can stop cancer growth by blocking enzymes needed for cell growth. The trial includes imaging tests like X-rays and MRIs as well as biospecimen collection.

What are the potential side effects?

While the document does not list specific side effects of erdafitinib, similar medications often cause diarrhea, dry mouth, nail changes, low appetite, altered taste sensation, hair loss and may affect liver function which will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have never taken erdafitinib or similar FGFR inhibitor drugs.

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My liver enzyme (ALT) level is within the required range for the study.

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My kidney function tests are within the normal range.

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I can swallow pills without any issues.

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My body surface area is at least 0.53 square meters.

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I have received external beam radiation therapy.

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I have received radiopharmaceutical therapy.

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I have received a stem cell infusion, with or without total body irradiation.

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I am enrolled in APEC1621SC and assigned to MATCH in APEC1621B due to an actionable mutation.

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I am between 12 and 21 years old.

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My solid tumor cancer has not spread to my bone marrow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart rhythm problems or specific heart muscle conditions.

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I do not have any infections that are not under control.

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I have had serious heart or stroke issues in the last year.

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I am not currently taking any cancer treatment drugs.

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I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I have been on a stable or decreasing dose of corticosteroids for at least 7 days.

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I am not taking drugs that strongly affect CYP2C9 enzyme activity.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Secondary study objectives

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Pharmacokinetic (PK) Parameters

Progression Free Survival (PFS)

Other study objectives

Changes in Tumor Genomic Profile

Side effects data

From 2024 Phase 1 trial • 35 Patients • NCT03238196

75%

Diarrhea

75%

Oral mucositis

50%

Hypomagnesemia

50%

Nausea

50%

Dry skin

25%

Aspartate aminotransferase increased

25%

Epistaxis

25%

Peripheral motor neuropathy

25%

Neutrophil decreased

25%

White blood cell decreased

25%

Flushing

25%

Bullous dermatitis

25%

Alkaline phosphatase increased

25%

Palmar-plantar erythrodysesthesia

25%

Alanine aminotransferase increased

25%

Fatigue

25%

Anxiety

25%

Dysgeusia

25%

Dysphasia

25%

Hyperparathyroidism

25%

Arthralgia

25%

Flank pain

25%

Blurred vision

25%

Back pain

25%

Dry mouth

25%

Vomiting

25%

Constipation

25%

Alopecia

25%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Fulvestrant 500mg, Palbociclib 125mg and Erdafitinib 8mg

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 6mg

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 5mg

Expansion

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 (erdafitinib)Experimental Treatment11 Interventions

Patients 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, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180