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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: Completed Phase 1 study, sponsored by Acrotech Biopharma.
NCT01222780 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicity was graded according to the version 4.0 of the NCI Common Toxicity Criteria (CTCAE v4.0).
Interventions
- DRUG Marqibo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01222780 record still lists
NCT01222780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Marqibo is the first listed.
NCT01222780 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01222780's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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