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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 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.

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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

Acute Myeloid Leukemia Myelodysplastic Syndrome

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

FieldValue
Enrollment Target 29 participants
Start Date 2009-01
Est. Completion 2025-12
Phase Phase 1

Sponsor

Richard Stone, MD

2 total trials

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What the Registry Record Tells You About NCT00819546

The ClinicalTrials.gov registry entry for NCT00819546 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (75% lower). The listed sponsor is Richard Stone, MD, which has 2 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.