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Closed (no longer recruiting)Last updated: 15 August 2023

KOMET: This phase III study is trying to understand how safe and effective targeted therapy (selumetinib) is compared to placebo, in adults with neurofibromatosis 1 who have symptomatic, inoperable plexiform neurofibromaA 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)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental or Placebo Comparator Arm. In the Experimental Arm, participants will receive selumetinib via oral capsule. In the Placebo Comparator Arm, participants will receive placebo via oral capsule.

Conditions

This trial is treating patients with people with neurofibrosis 1 who have symptomatic, inoperable plexiform neurofibromas.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18+

Phase

III

Trial Acronym

KOMET

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca

Scientific Title

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)

Eligibility

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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