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MDM2 Inhibitor
KRT-232 + Chemotherapy for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after last patient enrolled
Awards & highlights
Study Summary
This trial is studying KRT-232, a new drug that may help treat AML or MPN. Patients who have failed other treatments may be eligible to participate.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who have not responded to previous treatments. It's open to those with AML following a myeloproliferative disorder, provided they've had certain prior therapies and their liver and kidneys are functioning well. However, it excludes recent recipients of high-dose cytarabine or decitabine, those who've had a stem cell transplant within the last 3 months, or anyone currently dealing with graft-versus-host disease.Check my eligibility
What is being tested?
The study tests KRT-232 alone or combined with low-dose Cytarabine (LDAC) or Decitabine in treating AML. Participants will be assigned to either monotherapy with KRT-232 or combination therapy where KRT-232 is paired with one of the other drugs.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal symptoms like nausea and vomiting, blood count abnormalities which can increase infection risk, liver and kidney function changes, fatigue, and possible allergic reactions related to drug infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML that has come back, is not responding to treatment, or started due to another blood condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after last patient enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after last patient enrolled
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: To determine KRT-232 recommended phase 2 dose (RP2D)
Part B: To determine the RP2D of KRT-232
Secondary outcome measures
Part A: To determine the rates of complete remission (CR) and complete remission with partial hematological improvement (CRh)
Part B: To determine the rates of complete remission (CR), CR with partial hematological improvement (CRh) and CR with incomplete hematologic recovery (CRi)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Part B - Arm 3Experimental Treatment1 Intervention
KRT-232 administered at 180 mg orally, once daily (QD) on Days 1-7 with 14 days off on a 21-day treatment cycle.
Group II: Part B - Arm 2Experimental Treatment1 Intervention
KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle in Cycle 1, followed by 240 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day cycle, in the subsequent cycles.
Group III: Part B - Arm 1Experimental Treatment1 Intervention
KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle
Group IV: Part A - Arm 3Experimental Treatment2 Interventions
KRT-232(14-Day)+Decitabine:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 and Days 15-21 (7 days on/7 days off/7 days on/7 days off) in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.
Group V: Part A - Arm 2Experimental Treatment2 Interventions
KRT-232(7-Day)+Decitabine:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.
Group VI: Part A - Arm 1Experimental Treatment2 Interventions
KRT-232+LDAC:
KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with LDAC administered at 20 mg/m2/day subcutaneously on Days 1-10 in a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Decitabine
2004
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received more than 18 g/m2 of cytarabine in the last 3 months.My liver and kidneys are working well.I have been treated with an MDM2 antagonist before.I have been treated with FLT3 or IDH1/2 inhibitors if it was relevant for my condition.I have received treatment for graft-versus-host disease within the last month.I am not pregnant or breastfeeding.I am eligible for a stem cell transplant from a donor, or I have refused the transplant.I have AML that developed from a previous blood disorder and have been treated for it.I have not been treated with decitabine before.I have had a bone marrow transplant from a donor within the last 3 months or I am currently being treated for graft-versus-host disease.I have not had a stem cell transplant in the last 3 months and do not have active graft-versus-host disease.I have not had major surgery within the last 4 weeks.I have AML that developed from a previous blood disorder and have been treated for it.I have AML or APL with CNS involvement or a history of bleeding problems.I have AML that has come back, is not responding to treatment, or started due to another blood condition.My cancer has a TP53 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Part A - Arm 3
- Group 2: Part B - Arm 1
- Group 3: Part A - Arm 1
- Group 4: Part A - Arm 2
- Group 5: Part B - Arm 2
- Group 6: Part B - Arm 3
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.
To what health conditions is KRT-232 an effective treatment option?
"KRT-232 is an effective intervention for intermediate-2 IPSS risk category, refractory anaemia, and blast phase chronic myelocytic leukaemia."
Answered by AI
Are recruitment efforts still underway for this trial?
"Affirmative. As detailed on clinicaltrials.gov, the trial is still in search of willing participants; it initially went live on September 25th 2019 and was recently updated on August 3rd 2022. This study calls for 86 volunteers to be recruited across 7 distinct medical centres."
Answered by AI
Are there any prior research endeavors involving KRT-232?
"As of current time, there are 330 ongoing clinical trials analyzing the effects of KRT-232 with 72 in their advanced Phase 3 stage. Of these sites, most are located within New york City; however, 10877 locations worldwide have been identified as having active studies for this particular medication."
Answered by AI
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