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NCT00819546 · ClinicalTrials.gov registry record · Phase 1
RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Richard Stone, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 3
- Study locations
NCT00819546: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Richard Stone, MD.
NCT00819546 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by Richard Stone, MD. The registered enrollment target is 29 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819546, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Richard Stone, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to determine the safety of the combination of RAD001 and PKC412 as a cancer treatment, and to establish the highest dose of RAD001 that can be given in conjunction with PKC412. These drugs have been used in other research trials for individuals with solid and hematology malignancies. Past research on PKC412 shows that it blocks the abnormal functioning of an enzyme called FLT3. FLT3 is found in your cells in either a normal (wild type) or genetically changed form and plays a role in the survival and growth of AML cells. RAD001 is an inhibitor of a central growth pathway that involves the protein MTOR. The MTOR pathway is overactive in cancer cells, causing the cells to grow abnormally. By inhibiting the abnormal growth activity of the MTOR pathway, RAD001 slows down and possibly stops the growth of cancer cells.
Conditions Studied
Interventions
- DRUG RAD001
- DRUG PKC412
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT00819546 still lists
NCT00819546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which RAD001 is the first listed.
NCT00819546 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00819546 about?
NCT00819546 is a clinical study titled "RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS". The purpose of this research study is to determine the safety of the combination of RAD001 and PKC412 as a cancer treatment, and to establish the highest dose of RAD001 that can be given in conjunction with PKC412. These drugs have been used in other research trials for individuals with solid and he...
What is the current status of trial NCT00819546?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2009-01. Estimated completion is 2025-12.
What conditions does trial NCT00819546 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00819546?
The interventions under investigation include: RAD001 (DRUG), PKC412 (DRUG).
Who is sponsoring clinical trial NCT00819546?
This trial is sponsored by Richard Stone, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00819546 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00819546's enrollment target sits among peer trials
29 211th of 306 higher than 95 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid 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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