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NCT01523977 · ClinicalTrials.gov registry record · Phase 1
Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01523977 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 22 participants.
The verdict
NCT01523977, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensively studied in people with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of other drugs. Studies in adults with cancer have also evaluated Everolimus in combination with other anti-tumor drugs. Information from lab studies and some other clinical trials suggests that Everolimus may kill leukemia cells on its own, and also make it more likely that steroids (such as prednisone) are able to kill leukemia cells. In this research study, we are looking to learn more about how Everolimus works in combination with other drugs which are commonly used to treat relapsed acute lymphoblastic leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the study is to evaluate the side effects of this treatment combination in order to determine a safe dose of Everolimus which can be given with these other 4 drugs.
Interventions
- DRUG Doxorubicin
- DRUG Everolimus
- DRUG Vincristine
- DRUG Prednisone
- DRUG PEG-Asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01523977
The ClinicalTrials.gov registry entry for NCT01523977 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 Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT01523977 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01523977 about?
NCT01523977 is a clinical study titled "Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL". Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensivel...
What is the current status of trial NCT01523977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-11. Estimated completion is 2018-11.
What interventions are being tested in trial NCT01523977?
The interventions under investigation include: Doxorubicin (DRUG), Everolimus (DRUG), Vincristine (DRUG), Prednisone (DRUG), PEG-Asparaginase (DRUG).
Who is sponsoring clinical trial NCT01523977?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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