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Menin-MLL(KMT2A) Inhibitor
Ziftomenib for Relapsed/Refractory Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Kura Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with refractory or relapsed AML defined as the reappearance of ≥ 5% blasts in the bone marrow and who have also failed or are ineligible for any approved standard of care therapies, including HSCT.
Phase 1b: Patients with a documented lysine[K]-specific methyltransferase 2-rearrangement (KMT2A-r), or Patients with a documented nucleophosmin 1 mutation (NPM1-m)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following end of treatment
Awards & highlights
Study Summary
This trial will test a new drug, ziftomenib, on patients with a specific kind of leukemia that has returned or does not respond to treatment.
Who is the study for?
Adults with relapsed or refractory acute myeloid leukemia (AML) who have failed standard treatments can join this trial. They must have controlled white blood cell counts, be in relatively good health, and agree to use effective contraception. People with active central nervous system leukemia, recent heart issues, uncontrolled infections, or those on certain drugs that affect liver enzymes are excluded.Check my eligibility
What is being tested?
The study is testing Ziftomenib's safety and effectiveness for AML patients whose disease has returned or hasn't responded to treatment. It's a two-phase trial: the first phase adjusts doses; the second expands testing specifically to patients with an NPM1 mutation.See study design
What are the potential side effects?
As this is a first-in-human study of Ziftomenib, side effects are being closely monitored but may include typical chemotherapy-related symptoms such as fatigue, nausea, increased risk of infection due to lowered immunity, liver and kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML has returned or didn't respond to treatment, and I can't have or failed standard treatments.
Select...
My cancer has a specific genetic change (KMT2A-r or NPM1-m).
Select...
I can care for myself and doctors expect me to live at least 2 more months.
Select...
My cancer has a NPM1 mutation.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
Phase 1b: Minimal biologically effective dose
Phase 1b: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
+1 moreSecondary outcome measures
Phase 1a: AUC(0-last)
Phase 1a: Cmax
Phase 1a: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
NPM1-m patients will receive the recommended phase 2 dose determined in Phase 1
Group II: Phase 1b - Dose-Validation ExpansionExperimental Treatment1 Intervention
Cohort 1: KMT2A-r / NPM1-m patients will receive a dose previously studied in Phase 1a
Cohort 2: KMT2A-r / NPM1-m patients will receive a dose previously studied in Phase 1a
Group III: Phase 1a - Dose EscalationExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Kura Oncology, Inc.Lead Sponsor
15 Previous Clinical Trials
1,323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from major side effects of previous treatments.I am not taking strong drugs that affect liver enzyme CYP3A4, except for necessary antibiotics, antifungals, or antivirals.My liver and kidneys are working well.I am on immunosuppressive therapy after a stem cell transplant.I agree to use effective birth control during and for 6 months after the study.I agree to use effective birth control during and for 3 months after the study.My AML has returned or didn't respond to treatment, and I can't have or failed standard treatments.I have not received a donor lymphocyte infusion in the last 30 days.I do not have serious heart problems or a stroke in the last 6 months.I have a condition that increases my risk of serious infections.My white blood cell count is 30,000 or less.My cancer has a specific genetic change (KMT2A-r or NPM1-m).I have not had major surgery in the last 4 weeks.I had a stem cell transplant but my blood counts haven't recovered.I haven't had any experimental treatments in the last 14 days or within 5 half-lives before starting ziftomenib.I do not have any active, uncontrolled infections.I can care for myself and doctors expect me to live at least 2 more months.My cancer has a NPM1 mutation.I am 18 years old or older.I am experiencing moderate to severe symptoms from a transplant complication.My leukemia is affecting my brain or spinal cord.I have been diagnosed with acute promyelocytic leukemia.My condition is advanced chronic myelogenous leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a - Dose Escalation
- Group 2: Phase 1b - Dose-Validation Expansion
- Group 3: Phase 2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How big is the recruitment pool for this clinical trial?
"In order to complete this clinical trial, 60 individuals who meet the pre-determined inclusion criteria are required. Those interested can inquire about participating at Mayo Clinic in Rochester, Minnesota or UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania."
Answered by AI
Are they still enrolling patients for this clinical trial?
"Yes, this research is still looking for participants. The clinicaltrials.gov website shows that the trial was first advertised on September 12th, 2019 and updated as recently as April 29th, 2022."
Answered by AI
If this trial is successful, how many other medical facilities will be interested in running it?
"Currently, this experiment is being conducted in 18 different locations. If you are interested in enrolling, please choose the site nearest to your residence to minimize travel costs and time."
Answered by AI
Why was this particular clinical trial designed?
"The primary objective for this study, which will be measured over the course of 28 days to assess Dose Limiting Toxicities, is to establish a Maximum Tolerated Dose or Recommended Phase 2 Dose. Additionally, this trial will also measure secondary objectives including Part 1a: Cmax (Maximum plasma concentration of ziftomenib), Part 1a: AUC(0-last) (Area under the plasma concentration-time curve from time 0 to last measurable concentration of ziftomenib), and Part 1a: Tmax (Time to observed maximum plasma concentration of ziftomenib)."
Answered by AI
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