Clinical trial · Interventional
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)
NCT04113616CI-TRIAL-00075345terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In September 2023, the study was terminated because of a Sponsor decision, unrelated to safety concerns.
Summary
Brief summary (as posted)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed or Refractory Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| KRT-232 | Drug | Navtemadlin | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part A - Arm 1
- description
- 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.
- interventionNames
- Drug: KRT-232
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Part A - Arm 2
- description
- 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.
- interventionNames
- Drug: KRT-232
- Drug: Decitabine
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN * Part B:Patients with relapsed or refractory AML secondary to MPN (myelofibrosis \[MF\], polycythemia vera \[PV\], or essential thrombocythemia \[ET\]); patients may have been treated with ≥1 prior lines of therapy for their AML secondary to MPN. * Adequate hepatic and renal function * Appropriate prior treatment with an FLT3 or IDH1/2 inhibitor where applicable Key Exclusion Criteria: * Patients who are TP53 mutation positive * Prior treatment with an MDM2 antagonist therapy * Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for Part A) . * Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A) . * Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A) * Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B) * Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study * Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study. * Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis * Patients who have had major surgery within 28 days prior to the first treatment with KRT-232 * Women who are pregnant or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.