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Official Title

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A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas

This is a randomized, double-blind, placebo-controlled, 2 arm multicentre, global Phase III study to assess the efficacy and safety of selumetinib compared with placebo in adult participants with NF1 who have symptomatic, inoperable PN.

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Therapeutic Area

Selumetinib oral capsules (10 mg and 25  mg)

Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)

Research Site

A Phase III, Multicentre, International Study with a Parallel,
Randomised, Double-blind, Placebo-controlled, 2 Arm Design to
Assess the Efficacy and Safety of Selumetinib in Adult
Participants with NF1 who have Symptomatic, Inoperable
Plexiform Neurofibromas (KOMET)

ORR will be defined as the proportion of patients who have a confirmed complete response or confirmed partial response as determined by ICR per REiNS criteria

Difference in mean change from baseline in chronic target PN pain intensity score between Arm A and Arm B, obtained using an NRS-11 scale to assess pain intensity of a target plexiform neurofibroma

DoR will be defined as the time from the date of first documented response (which is subsequently confirmed) until progression by ICR per REiNS criteria or death due to any cause

PFS will be defined as the time from first selumetinib dose until date of disease progression by ICR per REiNS criteria or death due to any cause

TTP is defined as the time from the date of first selumetinib dose until date of disease progression by ICR per REiNS criteria

TTR is defined as the time from date of first selumetinib dose until the date of objective response by ICR per REiNS criteria

Difference in best percentage change from baseline in target PN volume by ICR per REiNS criteria

Difference in change from baseline between Arm A and Arm B

Arms	Assigned Interventions
Experimental: Arm A Selumetinib	Drug: Selumetinib Selumetinib oral capsules (10 mg and 25 mg) Other Name: AZD6244
Placebo Comparator: Arm B Placebo	Other: Placebo Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)

Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas - KOMET

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