Your session is about to expire
← Back to Search
Anti-metabolites
Rezatapopt + Azacitidine for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase 1
Waitlist Available
Led By Courtney DiNardo, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency >2%
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Must not have
Patients with acute promyelocytic leukemia
Subject has known active viral infection with HIV, HBV, or HCV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the drug PC14586 in patients with a specific type of blood cancer called myeloid malignancies, which include AML and MDS, and have a specific genetic mutation called
Who is the study for?
This trial is for adults with TP53Y220C mutant myeloid malignancies, such as AML or MDS. Participants must have a specific mutation frequency, be in good enough health to perform daily activities (ECOG ≤2), and agree to use contraception. It's not for those with severe leukemia complications, recent major surgery, active infections including HIV/HBV/HCV, unresolved toxicities from past cancer treatments, or CNS involvement by leukemia.
What is being tested?
The study tests Rezatapopt combined with Azacitidine or both Azacitidine and Venetoclax in patients with certain genetic mutations causing blood cancers like AML and MDS. The trial is non-randomized phase Ib which means it's early in testing the safety and how well these drugs work together.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation, gastrointestinal issues due to drug ingestion or absorption problems, allergic reactions similar to other compounds used in the study drugs' composition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific TP53 mutation.
Select...
I can perform daily activities with minimal assistance.
Select...
My AML or MDS has returned or did not respond to initial treatment.
Select...
I am 18 years old or older.
Select...
My MDS is classified as either MDS-IB1 or IB2.
Select...
I have been newly diagnosed with AML or MDS and cannot undergo intensive chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I have an active HIV, HBV, or HCV infection.
Select...
I do not have any ongoing serious infections.
Select...
I am currently pregnant or breastfeeding.
Select...
I have side effects from cancer treatment that are not mild.
Select...
I have had cancer treatment like chemotherapy or immunotherapy recently.
Select...
I have undergone radiotherapy in the last 14 days.
Select...
My leukemia is causing severe, life-threatening complications.
Select...
I have leukemia that is affecting my brain and it's not under control.
Select...
I have a condition that affects my ability to take or absorb medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and adverse events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Rezatapopt + Azacitidine + VenetoclaxExperimental Treatment3 Interventions
Participants will receive treatment on an inpatient or outpatient basis.
Group II: Rezatapopt + AzacitidineExperimental Treatment2 Interventions
Participants will receive treatment on an inpatient or outpatient basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer Center (MSK)UNKNOWN
PMV Pharmaceuticals, IncIndustry Sponsor
5 Previous Clinical Trials
312 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,783 Total Patients Enrolled
Courtney DiNardo, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
13 Previous Clinical Trials
624 Total Patients Enrolled