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Protein Kinase Inhibitor

RAD001 + PKC412 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Richard Stone, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status of 2 or less
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study the safety and efficacy of the combination of RAD001 and PKC412 in subjects with relapsed or refractory solid tumors or hematologic malignancies.

Who is the study for?
This trial is for adults with relapsed or refractory AML, MDS, or CMML who can't have standard therapy. They should be in relatively stable health (ECOG ≤2), not pregnant, using double barrier contraception if of childbearing potential, and without recent transplants or other cancers within 5 years.Check my eligibility
What is being tested?
The study tests RAD001 combined with PKC412 to find the safest high dose against certain blood cancers. RAD001 targets a protein pathway that's overactive in cancer cells while PKC412 blocks an enzyme linked to AML cell growth.See study design
What are the potential side effects?
Potential side effects may include abnormal cholesterol or triglyceride levels, digestive system issues affecting drug absorption, increased risk of infection due to immune suppression, and possible allergic reactions to the drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but cannot do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Leukemia, Myelocytic, Acute
Secondary outcome measures
Measure pharmacokinetics of each agent when administered in combination.
Observe anti-leukemic effects of this combination including a coda of patients with mutant FLT3 AML.
Observe the pharmacodynamic effects on the phosphorylation of FLT3 and on activation of relevant signaling pathways and correlate such activation with response.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Only one arm on this study.Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RAD001
2012
Completed Phase 3
~1570
PKC412
2011
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,241 Total Patients Enrolled
Richard Stone, MDLead Sponsor
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,307 Total Patients Enrolled

Media Library

PKC412 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00819546 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Only one arm on this study.
Acute Myeloid Leukemia Clinical Trial 2023: PKC412 Highlights & Side Effects. Trial Name: NCT00819546 — Phase 1
PKC412 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00819546 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutic intervention been given the green light by the Food and Drug Administration?

"Due to the paucity of data supporting efficacy and safety, this treatment was assigned a score of 1 on our team's scale. This marks it as being an early-phase clinical trial."

Answered by AI

Are there opportunities to join this experiment currently available?

"According to clinicaltrials.gov, this particular research project is no longer searching for participants, as it was first posted in 2009 and last updated in 2023. However, there are 859 other trials currently enrolling patients at this time."

Answered by AI

Has anything like this research endeavor been attempted before?

"This treatment has been under the microscope since 2008, when Novartis Pharmaceuticals organized a pilot study of 717 participants. After Phase 3 drug approval was granted in response to this initial trial, 95 active studies for it have appeared across 1208 cities and 45 countries."

Answered by AI

What is the current scope of enrollment for this research endeavor?

"Sadly, this research is no longer recruiting. It was initially listed on 1/1/2009 and last modified on 2/6/2023. If you seek an alternate trial, there are currently 764 studies for myelodysplastic syndrome patients actively looking for volunteers as well as 95 trials searching for participants related to this particular treatment."

Answered by AI

What customary applications does this therapy encompass?

"This treatment is suitable for organ transplant rejection, specifically liver and kidney transplants, as well as Waldenstrom Macroglobulinemia and lung conditions."

Answered by AI
~3 spots leftby Dec 2025