Clinical Trials

active infection, active
bleeding diatheses, or renal transplant, including any patient known to have hepatitis
B, hepatitis C, or human immunodeficiency virus (HIV) will be excluded.

5. Participants who, in the opinion of the investigator, may not be able to comply with
the safety monitoring requirements of the study.

6. Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory
bowel disease), or significant bowel resection that would preclude adequate
absorption.

7. Supplementation with vitamin E greater than 100% of the daily recommended dose. Any
multivitamin containing vitamin E must be stopped prior to initiation of therapy.

8. Participants not achieving adequate blood pressure despite antihypertensive therapy
for control of blood pressure.

9. Cardiac conditions:

1. Known inherited coronary disease

2. Symptomatic heart failure (NYHA Class II-IV prior or current cardiomyopathy, or
severe valvular heart disease)

3. Prior or current cardiomyopathy

4. Severe valvular heart disease

5. History of atrial fibrillation

10. Ophthalmologic conditions:

1. Current or past history of central serous retinopathy or retinal pigment
epithelial detachment (RPED).

2. Current or past history of retinal vein occlusion.

3. History of radiation therapy that included the orbit in the field of treatment.

4. Known intraocular pressure (IOP) > 21 mmHg (or ULN adjusted by age) or
uncontrolled glaucoma (irrespective of IOP). Participants with known glaucoma and
increased IOP who do not have meaningful vision (light perception only or no
light perception) and are not experiencing pain related to the glaucoma, may be
eligible after discussion with the study chair.

5. Participants with any other significant abnormality on ophthalmic examination
should be discussed with the Study Chair for potential eligibility.

6. Ophthalmological findings secondary to long-standing optic pathway glioma (such
as visual loss, optic nerve pallor or strabismus) will NOT be considered a
significant abnormality for the purposes of the study.

11. Known severe hypersensitivity to selumetinib or any excipient of selumetinib or
history of allergic reactions attributed to compounds of similar chemical or biologic
composition to selumetinib.

12. Recent major surgery within a minimum of 4 weeks prior to starting study treatment.

13. Any unresolved chronic toxicity with CTC AE grade ≥ 2 from previous therapy, except
for alopecia.

14. Receiving herbal supplements or medications known to be strong or moderate inhibitors
or inducers of the cytochrome P450 (CYP)2C19 and CYP3A4 enzymes or fluconazole unless
such products can be safely discontinued at least 14 days or 5 half-lives (whichever
is longer) before the first dose of study medication.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/20/2024. Questions regarding updates should be directed to the study team contact.