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NCT01222780 · ClinicalTrials.gov registry record · Phase 1
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
A Phase 1 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01222780 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 22 participants.
The verdict
NCT01222780, a Phase 1 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Background: * Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate, which is a widely used anticancer drug, and packages it into a tiny fat bubble known as a liposome. The goal of this is to improve the drug's ability to destroy cancer cells and help reduce the potential side effects of treatment. * Vincristine sulfate was originally developed from chemicals found in the periwinkle plant and acts against multiple types of malignant cancer. It is approved for multiple cancer types including solid tumors and blood cancers. * Research has shown that Marqibo(Registered Trademark) is able to slow or stop the growth of cancer cells in some adults, both alone and in combination with other chemotherapy drugs, but more research is needed to determine its use in children. * There has been one previous small study of Marqibo(Registered Trademark) in children. Although some anti-cancer activity was seen, side effects and optimal dosing were not fully determined. * As is seen with standard Vincristine suflate, the most common side effect of Marqibo(Registered Trademark) involves the nervous system. It can cause numbness and tingling in the hands and feet. Symptoms commonly improve when the drug is discontinued or the dose is lowered. Objectives: \- To determine the safety and efficacy of Marqibo as a treatment for children who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment. Eligibility: * Children and adolescents between 2 and 21 years of age who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment. * These cancer types include solids tumors, primary brain tumors, leukemias, and lymphomas.
Interventions
- DRUG Marqibo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01222780
The ClinicalTrials.gov registry entry for NCT01222780 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Marqibo is the first listed.
NCT01222780 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01222780 about?
NCT01222780 is a clinical study titled "To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer". Background: * Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate, which is a widely used anticancer drug, and packages it into a tiny fat bubble known as a liposome. The goal of this is to improve the drug's ability to destroy cancer cells and help reduce the po...
What is the current status of trial NCT01222780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2010-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01222780?
The interventions under investigation include: Marqibo (DRUG).
Who is sponsoring clinical trial NCT01222780?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
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