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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 belowSelect...
I can take care of myself but cannot do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreTrial 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
1,614 Previous Clinical Trials
2,721,365 Total Patients Enrolled
Richard Stone, MDLead Sponsor
Beth Israel Deaconess Medical CenterOTHER
839 Previous Clinical Trials
13,010,397 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with acute promyelocytic leukemia.I had a bone marrow or stem cell transplant less than 2 months ago.I do not have severe health or mental conditions that could stop me from completing the study.I currently have an infection that is not under control.I have high cholesterol or triglycerides despite taking medication.I can take care of myself but cannot do heavy physical work.I always follow my medical treatments as prescribed.I am on long-term steroids or other drugs that weaken my immune system.I have not had any live vaccines in the week before or during the study.I have not had any cancer except for certain skin or cervical cancers in the last 5 years.I don't expect to need treatment to reduce my blood cell count within a month, except for hydroxyurea.I have a stomach or intestine problem that affects how my body absorbs medication.My blood cancer diagnosis is confirmed and standard treatments haven't worked or aren't suitable for me.I am not pregnant, breastfeeding, and if capable of childbearing, I use effective contraception.I have tested positive for HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Only one arm on this study.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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