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NCT01362803 · ClinicalTrials.gov registry record · Phase 1
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
A Phase 1 study of Neurofibromatosis 1 and Neurofibromatosis Type 1, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
- 4
- Study locations
NCT01362803: Active Phase 1 study of Neurofibromatosis 1 and Neurofibromatosis Type 1, sponsored by National Cancer Institute (NCI).
NCT01362803 is a Phase 1 study of Neurofibromatosis 1 and Neurofibromatosis Type 1 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 99 participants, below the 1,031-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362803, a Phase 1 study of Neurofibromatosis 1 and Neurofibromatosis Type 1, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
- 4
- Study locations
Study Summary
Background: \- Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat them is with surgery. Some of these tumors cannot be completely removed. The tumors may be too large, too numerous, or in a bad location for surgery. An experimental drug called AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their growth, or shrink them. This drug has been tested in adults with cancer and in children with some types of brain cancer. This study will test how well this drug works with these types of tumors. Objectives: \- To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young adults with plexiform neurofibromas that cannot be completely removed by surgery. Eligibility: \- Children and young adults between 12 and 18 years of age who have plexiform neurofibromas that cannot be completely removed by surgery. Design: * Patients will be screened with a physical exam, medical history, blood tests, and imaging studies. * They will take the study drug twice a day with 8 ounces of water, every day for 28-day cycles of treatment. During study visits, participants will have blood and urine tests and physical exams. They will also have imaging studies to examine the tumor sizes and locations. They will answer questions about their health. They may have other tests as needed. * Participants will continue to receive the study drug as long as they have no severe side effects and the disease is not getting worse.
Primary Outcome
Evaluate the confirmed partial and complete response rate of selumetinib in children and young adults with NF1 and inoperable PN.
Conditions Studied
Interventions
- DRUG AZD6244
Study Locations (4)
District of Columbia
- Children's National Medical Center - Washington D.C.
Maryland
- National Institutes of Health Clinical Center - Bethesda
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2011-09-21 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 1 |
What the registry record for NCT01362803 still lists
NCT01362803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,031-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 1 intervention - of which AZD6244 is the first listed.
NCT01362803 reports a single indexed study location in District of Columbia, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT01362803 about?
NCT01362803 is a clinical study titled "AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors". Background: \- Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat them is with surgery. Some of these tumors cannot be completely removed. The tumors may be too large, too numerous, or in a bad location for surgery. An experimental drug called AZD6244 hydrogen ...
What is the current status of trial NCT01362803?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2011-09-21. Estimated completion is 2032-01-01.
What conditions does trial NCT01362803 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Neurofibromatosis Type 1, NF1, Neurofibroma Plexiform.
What interventions are being tested in trial NCT01362803?
The interventions under investigation include: AZD6244 (DRUG).
Who is sponsoring clinical trial NCT01362803?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01362803 being conducted?
This trial has 4 study locations across District of Columbia, Maryland, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01362803's enrollment target sits among peer trials
99 12th of 24 higher than 13 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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