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NCT01445080 · ClinicalTrials.gov registry record · Phase 1
Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
A Phase 1 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT01445080: Completed Phase 1 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
NCT01445080 is a Phase 1 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 132-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445080, a Phase 1 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Primary Outcome
Number of patients with treatment-related dose limiting toxicities in cycle 1, as defined by study protocol, stratified by dose level.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Sorafenib Tosylate
Study Locations (20)
California
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Indiana
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
- Riley Hospital for Children - Indianapolis
New York
- Columbia University/Herbert Irving Cancer Center - New York
- State University of New York Upstate Medical University - Syracuse
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2006-05-30 |
| Est. Completion | 2012-12-10 |
| Phase | Phase 1 |
What the finished NCT01445080 record still lists
NCT01445080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 132-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (47% lower).
The record links to 10 conditions, with Juvenile Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01445080 names 20 study sites across 16 states, led by California, Indiana, New York.
Frequently Asked Questions
What is clinical trial NCT01445080 about?
NCT01445080 is a clinical study titled "Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia". This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer...
What is the current status of trial NCT01445080?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2006-05-30. Estimated completion is 2012-12-10.
What conditions does trial NCT01445080 study?
This clinical trial studies the following conditions: Juvenile Myelomonocytic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Childhood Acute Myeloid Leukemia, Blastic Phase.
What interventions are being tested in trial NCT01445080?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT01445080?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01445080 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Juvenile Myelomonocytic Leukemia
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Where NCT01445080's enrollment target sits among peer trials
70 3rd of 11 higher than 9 of 11 other Juvenile Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Juvenile Myelomonocytic Leukemia 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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