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NCT01324180 · ClinicalTrials.gov registry record · Phase 1
Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01324180 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 14 participants.
The verdict
NCT01324180, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of the trial is to study the clinical and biological effects of metformin in combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a dismal outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose (MTD) of metformin in conjunction with ALL therapy. There have also been analysis of patients enrolled on trials who were diabetics on metformin and their outcome was better than patients on the same trial that were not on metformin as their antihyperglycemic.
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Metformin
- DRUG Vincristine
- DRUG PEG-asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-07-18 |
| Est. Completion | 2017-07-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324180
The ClinicalTrials.gov registry entry for NCT01324180 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT01324180 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01324180 about?
NCT01324180 is a clinical study titled "Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)". H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of the trial is to study the clinical and biological effects of metformin in combination with standard systemic chemotherapy in a disease (relapsed ALL) that...
What is the current status of trial NCT01324180?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-07-18. Estimated completion is 2017-07-27.
What interventions are being tested in trial NCT01324180?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Metformin (DRUG), Vincristine (DRUG), PEG-asparaginase (DRUG).
Who is sponsoring clinical trial NCT01324180?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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