US Selumetinib Registry
Study Identifier:
ALX-NF1-501
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Unmapped
Study Drug
Date
Jan 2019 - Nov 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants diagnosed with NF1 and PN
- Started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 April 2020, including patients who:
- Discontinued selumetinib before enrollment; or
- Initiated treatment before enrollment and are currently on selumetinib; or
- Initiated selumetinib on the day of enrollment or intend to initiate selumetinib within 3 months after enrollment
- Able to give written informed consent. Participant or participant's parent/legal guardian must be willing and able to give written informed consent and the participant (if minor) must be willing to give written informed assent.
Exclusion Criteria
- Participants currently participating in any clinical trials at time of enrollment or initiation of selumetinib.
Sex
Female & Male
Age
2 - 18 Years
Study Details
Medical Condition
- Unmapped
Study Drug
Date
Jan 2019 - Nov 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants diagnosed with NF1 and PN
- Started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 April 2020, including patients who:
- Discontinued selumetinib before enrollment; or
- Initiated treatment before enrollment and are currently on selumetinib; or
- Initiated selumetinib on the day of enrollment or intend to initiate selumetinib within 3 months after enrollment
- Able to give written informed consent. Participant or participant's parent/legal guardian must be willing and able to give written informed consent and the participant (if minor) must be willing to give written informed assent.
Exclusion Criteria
- Participants currently participating in any clinical trials at time of enrollment or initiation of selumetinib.
Protocol Summary
The purpose of this study is to understand treatment patterns and assess long-term effectiveness and safety outcomes associated with selumetinib treatment as well as to explore clinical and non-clinical factors affecting those outcomes in patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs) who started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 April 2020 in a real-world setting.
Trial Locations
Location
Status
Location
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
N/A
Location
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-6062
Status
N/A
Location
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Status
N/A
Location
Arnold Palmer Hospital For Children
Orlando, Florida, United States, 32806
Status
N/A
Location
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Status
N/A
Location
Mayo Clinic
Rochester, Minnesota, United States, 55905
Status
N/A
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