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RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
NCT00819546 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00819546
The ClinicalTrials.gov registry entry for NCT00819546 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Richard Stone, MD, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00819546 reports 3 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00819546?
The interventions under investigation include: RAD001 (DRUG), PKC412 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00819546?
This trial is sponsored by Richard Stone, MD, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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