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Kinase Inhibitor

Selumetinib for Neurofibromatosis (SEL-TH-1601 Trial)

Phase 2

Waitlist Available

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky ≥ 60% for patients > 16 years of age, Lansky ≥ 60 for patients ≤ 16 years of age

Patients must be able to swallow capsules

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 2 years

Awards & highlights

SEL-TH-1601 Trial Summary

This trial is testing if the drug selumetinib can stop the growth of tumors in patients with neurofibromatosis type II.

Who is the study for?

This trial is for patients with neurofibromatosis type II (NF2) related tumors, specifically those who have experienced hearing loss or tumor growth. Participants must be between 3-45 years old, able to swallow capsules, and have stable health without immediate need for surgery or radiation. Pregnant women and those on certain other treatments are excluded.Check my eligibility

What is being tested?

The study tests the drug selumetinib's effectiveness in stopping NF2 related tumor growth, improving hearing over six months, enhancing physical/emotional well-being and daily activity performance. It also examines if these tumors have targets responsive to selumetinib.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of drugs like selumetinib may include skin rash, nausea, fatigue, diarrhea, eye problems (like blurred vision), muscle aches and increased blood pressure. Specific side effects will be monitored throughout the trial.

SEL-TH-1601 Trial Eligibility Criteria

Inclusion Criteria

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

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

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I can swallow pills.

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My bone marrow, kidneys, liver, and brain are all working well.

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My heart functions well, with a good ejection fraction and normal EKG results.

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It has been over 6 months since my last radiation therapy for a tumor.

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I have been diagnosed with neurofibromatosis 2.

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My cancer has grown by at least 25% or worsened in the last 18 months.

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I have had a transplant over 3 months ago and do not currently have graft vs. host disease.

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I am between 3 and 45 years old.

SEL-TH-1601 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 2 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

Change in hearing response at 24 weeks

Response rate of other NF2 related tumors

Secondary outcome measures

Change in quality of life

Response rate of vestibular schwannomas

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214

75%

Diarrhea

50%

Fatigue

47%

Anemia

47%

Rash acneiform

44%

Hypoalbuminemia

44%

Edema, limbs

39%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

33%

White blood cell decreased

31%

Nausea

31%

Vomiting

28%

Platelet count decreased

25%

CPK increased

25%

Hypomagnesemia

22%

Hypertension

19%

Hypophosphatemia

19%

Hypocalcemia

19%

Hyponatremia

19%

Edema, face

17%

Dry skin

17%

Alanine aminotransferase increased

14%

Skin and subcutaneous tissue disorders - Other

14%

Hypokalemia

14%

Creatinine increased

14%

Back pain

14%

Dyspnea

14%

Lymphocyte count decreased

11%

Pain

11%

Fever

11%

Localized edema

11%

Peripheral sensory neuropathy

11%

Hyperkalemia

11%

Dizziness

11%

Abdominal pain

Acute kidney injury

Hypoglycemia

Anorexia

Death, NOS

Periorbital edema

Skin hypopigmentation

Pain in extremity

Cough

Insomnia

Alkaline phosphatase increased

Dry mouth

Sepsis

Renal and urinary disorders - Other

Dehydration

Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis

Hypernatremia

Blood and lymphatic system disorders - Other

Hypercalcemia

Metabolism and nutrition disorders - Other

Chills

Hypotension

Myalgia

Arthralgia

Upper respiratory infection

Headache

Sinusitis

Generalized muscle weakness

Gastrointestinal disorders - Other

Gastroesophageal reflux disease

Confusion

Vaginal inflammation

Pruritus

Febrile neutropenia

Flu like symptoms

Hepatic failure

Skin infection

Fall

Fracture

Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral

Adult respiratory distress syndrome

Renal and urinary disorders - Other, Acute renal failure

INR increased

100%

80%

60%

40%

20%

Study treatment Arm

AZD6244 (Selumetinib) Treatment

SEL-TH-1601 Trial Design

2Treatment groups

Experimental Treatment

Group I: Stratum 2: other NF2 related tumors (meningiomas and ependymoma)Experimental Treatment1 Intervention

Stratum 2 will include patients who have progressive lesions other than VS (including non-vestibular schwannomas, meningiomas, and spinal cord lesions). Participants will receive continuous twice daily dosing of selumentinib. Dosing is based on BSA calculated at the beginning of each course. One course is equivalent to 28 days. Therapy may continue for up to two years (26 courses) in the absence of disease progression or unacceptable toxicity.

Group II: Stratum 1 - NF2 related vestibular schwannomas- NOW CLOSEDExperimental Treatment1 Intervention

Stratum 1 included patients with NF2 with vestibular schwannomas who exhibit hearing loss. Participants received continuous twice daily dosing of selumetinib. Dosing was based on BSA calculated at the beginning of each course. One course is equivalent to 28 days. Therapy continued for up to two years (26 courses) in the absence of disease progression or unacceptable toxicity. Stratum 1 arm was closed in November, 2022.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selumetinib

2010

Completed Phase 2

~2050

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,562 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,868 Total Patients Enrolled

Trent Hummel, MDStudy ChairChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

1,500 Total Patients Enrolled

Media Library

Selumetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03095248 — Phase 2

Neurofibromatosis Research Study Groups: Stratum 1 - NF2 related vestibular schwannomas- NOW CLOSED, Stratum 2: other NF2 related tumors (meningiomas and ependymoma)

Neurofibromatosis Clinical Trial 2023: Selumetinib Highlights & Side Effects. Trial Name: NCT03095248 — Phase 2

Selumetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03095248 — Phase 2

Frequently Asked Questions

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

Has the Food and Drug Administration allowed Selumetinib to be utilized medicinally?

"Selumetinib received a score of 2 as there is limited evidence confirming its safety; no clinical trials have been conducted to prove efficacy."

Answered by AI

Has there been any prior research of this kind?

"Selumetinib's inception dates back to 2007 with a pioneering study sponsored by AstraZeneca. This research, involving 58 participants, led the drug to its Phase 1 approval. Currently, there are 34 active investigations of Selumetinib in 33 countries and 156 cities worldwide."

Answered by AI

Are there still openings to participate in this research experiment?

"Affirmative, according to clinicaltrials.gov records this trial is still recruiting patients. It was first listed on May 8th 2017 and modified most recently on April 7th 2022; it is currently seeking 34 participants across 1 medical centre."

Answered by AI

For which demographics is this medical experiment most suitable?

"This clinical trial is recruiting 34 patients aged 3 to 45 with ependymoma. Eligibility criteria include: fulfilling National Institute of Health (NIH) or Manchester requirements, bearing a causative mutation in the NF2 gene, having bilateral vestibular schwannomas, presenting first-degree relatives with NF2 and either unilateral eighth nerve mass OR two other conditions such as neurofibroma, meningioma, glioma, schwannoma; possessing a <85% word recognition score and >0%, exhibiting progression within 18 months via ≥ 20% increase in volume or new lesions/deterioration"

Answered by AI

What is the total number of participants in this experiment?

"Affirmative. Data gathered from clinicaltrials.gov reveals that this research endeavour, which was first posted on May 8th 2017, is looking to enroll 34 patients at 1 site."

Answered by AI

Is the patient eligibility criteria for this clinical trial extended to those of an advanced age?

"This clinical experiment is looking for volunteers aged between 3 and 45 years old."

Answered by AI

What prior research exists on Selumetinib's efficacy?

"Currently, there are 34 Selumetinib trials in effect, with 5 at Phase 3. Philadelphia is one of the cities conducting investigations on this drug; however, more than 1000 other locations have studies underway too."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors

2017. "Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03095248.

All > Acoustic Neuroma > Neurofibromatosis